Article

Feasibility, acceptability and effects of multimodal pelvic floor physical therapy for gynecological cancer survivors suffering from painful sexual intercourse: A multicenter prospective interventional study

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Abstract

Objectives: Painful sexual intercourse (dyspareunia) is a distressing condition affecting a large proportion of gynecological cancer survivors, yet treatments remain limited and poorly studied. This multicenter prospective interventional study examined the feasibility, acceptability and effects of multimodal pelvic floor physical therapy in gynecological cancer survivors with dyspareunia. Methods: Thirty-one endometrial and cervical cancer survivors with dyspareunia participated in 12 weekly 60-min physical therapy sessions combining education, manual therapy, pelvic floor muscle exercises using biofeedback and home exercises, which included the use of a dilator. The adherence rate to home exercises (≥80%), the attendance rate at physical therapy sessions (≥80% of participants attending ≥10 sessions) and the dropout rate (˂15%) served as feasibility and acceptability outcomes and benchmarks. Pain intensity, pain quality, sexual function, pelvic floor dysfunction symptoms and quality of life were measured at baseline and post-treatment. Treatment satisfaction and participants' perceived improvement were also assessed. Results: The adherence rate was 88% (SD 10), 29/31 (94%) women attended ≥10 treatment sessions, and the dropout rate was 3%. Moreover, women experienced significant improvements in all outcomes after the intervention (p ≤ 0.044). They also reported being highly satisfied with the treatment (9.3/10 (SD 1.2)), and 90% of them were very much or much improved. Conclusions: Our findings support the feasibility and acceptability of multimodal pelvic floor physical therapy for gynecological cancer survivors with dyspareunia. The intervention also led to significant improvements in pain, sexual function, pelvic floor dysfunction symptoms and quality of life. A randomized controlled trial is needed to confirm these results.

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... 17,20 A recent prospective study showed a statistically and clinically significant reduction in pain as well as an improvement in sexual function following multimodal physical therapy in women affected by dyspareunia after being treated for gynecologic malignancies. 21 Supporting the rationale for this treatment, a recent crosssectional comparative study showed heightened pelvic floor muscle tone, lower tissue flexibility, higher pelvic floor muscle stiffness as well as lower coordination and endurance using dynamometry and ultrasound imaging in women with dyspareunia after treatment for gynecologic malignancies in comparison to asymptomatic women. 9 These alterations can be addressed by physical therapy through education, pelvic floor muscle exercises and manual therapy. ...
... identifier: NCT03935698) was to assess the multidimensional effects of multimodal physical therapy in women with dyspareunia who had received oncological treatments for a gynecologic cancer. Please note that all details related to the feasibility and acceptability of the intervention as well as its effects on pain, sexual function and pelvic floor dysfunction symptoms with their impact on the quality of life have been published elsewhere 21 and those on pelvic floor muscle outcomes will be described in another manuscript. ...
... Further details of the treatment protocol are available elsewhere. 21 ...
Article
Background Dyspareunia affects most women after treatment for gynecologic malignancies. However, to date, evidence-based interventions remain limited and no study has examined the effects of multimodal physical therapy on psychosexual outcomes in these patients. Aim To assess the effects of multimodal physical therapy on psychosexual outcomes including sexual distress, body image concerns, pain anxiety, pain catastrophizing, pain self-efficacy and depressive symptoms in women with dyspareunia after treatment for gynecologic malignancies. Methods Thirty-one gynecologic cancer survivors with dyspareunia enrolled in this prospective single-arm interventional study. The participants undertook 12 weekly sessions of physical therapy incorporating education, pelvic floor muscle exercises with biofeedback, manual therapy and home exercises. Outcome measures were evaluated pre- and post-treatment. Paired t-tests were conducted to investigate the changes from pre-treatment (P-value ˂ 0.05) while effect sizes (Cohen's d) were calculated to measure the magnitude of the change. Main Outcome Measures Sexual distress (Female Sexual Distress Scale-Revised), body image concerns (Body Image Scale), pain anxiety (Pain Anxiety Symptoms Scale), pain catastrophizing (Pain Catastrophizing Scale), pain self-efficacy (Painful Intercourse Self-Efficacy Scale) and depressive symptoms (Beck Depression Inventory-II). Results Significant changes were found from pre- to post-treatment for all psychosexual outcomes. Women reported reductions in sexual distress (P ˂ 0.001, d = 1.108), body image concerns (P ˂ 0.001, d = 0.829), pain anxiety (P ˂ 0.001, d = 0.980), pain catastrophizing (P ˂ 0.001, d = 0.968) and depression symptoms (P = 0.002, d = 0.636) with an increase in pain self-efficacy (P ˂ 0.001, d ≥ 0.938) following the intervention. Clinical Implications The results suggest that multimodal physical therapy significantly improves sexual distress, body image concerns, pain anxiety, pain catastrophizing, pain self-efficacy and depressive symptoms in our sample of women with dyspareunia after treatment for gynecologic malignancies. The medium to large effect sizes obtained with the high proportion of women presenting meaningful changes according to the known minimal clinically important difference or clinical cut-off underlines the significance of these effects. Strengths & Limitations The current study used validated questionnaires to assess the psychosexual outcomes of a well-designed physical therapy intervention using multiple modalities to address the multifaceted aspect of dyspareunia in cancer survivors. This study did not include a control group, which may limit drawing definitive conclusions. Conclusion Findings showed that multimodal physical therapy yielded significant improvements in psychosexual outcomes in gynecologic cancer survivors with dyspareunia. A randomized controlled trial is indicated to confirm these results. Cyr M-P, Dumoulin C, Bessette P, et al. A Prospective Single-Arm Study Evaluating the Effects of a Multimodal Physical Therapy Intervention on Psychosexual Outcomes in Women With Dyspareunia After Gynecologic. J Sex Med 2021;XXX:XXX–XXX.
... Three before-after studies assessed the efficacy of combined pelvic floor therapy with psychoeducational interventions-mindfulness-based cognitive therapy (poor quality), topical intervention (olive oil and vaginal moisturizer) (poor quality), and insertion technique with vaginal dilator along with the use of vaginal lubricants and moisturizer for dyspareunia (good quality). [70][71][72] These multimodal interventions significantly improved sexual function, with moderate to large treatment effects. ...
... 25 However, the multimodal-intervention trials in our review used the combination of pelvic muscle therapy or relaxation (with vaginal dilators), psychoeducational therapy (ie, mindfulness cognitive therapy), and vaginal lubricant or moisturizer, which is different to the multimodal intervention recommended in the guidelines. [70][71][72] Moreover, this does align with a clinical-focused literature review on vaginal health management strategies in women cancer survivors by Carter et al, 89 which recommended clinicians integrate vaginal dilators, lubricant, and pelvic muscle exercise to improve vaginal discomfort and overall vaginal health. There is benefit in targeting multiple symptoms (particularly since sexual dysfunction has multiple causes); however, the studies reviewed were all uncontrolled small-scale studies, and thus further research is needed to elucidate the true effects of these interventions. ...
Article
Importance: Cancer and its treatment negatively affect female sexual health and function. The prevalence of female sexual dysfunction after cancer is between 33% and 43%. Numerous studies have addressed treatment options for sexual dysfunction in women with cancer, but it still remains a challenge to select the most efficacious option for patients. Objective: To compile and appraise recent evidence of any interventions for managing sexual dysfunction in female cancer survivors. Evidence review: A literature search of the electronic databases MEDLINE, EMBASE, PsycINFO, and Cochrane Central Register of Controlled Trials (January 2011 to February 2021) was conducted using general search terms of ‘‘women’’, ‘‘cancer’’, ‘‘intervention’’, ‘‘sexual dysfunction’’. We included randomized controlled trials (RCTs) and uncontrolled before-after studies that evaluated the efficacy of intervention for female sexual dysfunction in women with history of cancer. Methodological quality of studies was assessed using Risk of Bias (RoB) 2.0 for RCTs and National Institutes of Health (NIH) assessment tools for uncontrolled before-after studies. Findings: Thirty-six studies were included for qualitative synthesis (14 RCTs (n = 1284), 17 uncontrolled trials (n = 589), and 5 cohort studies (n = 497). Only four studies were at low risk of bias. Topical interventions (vaginal gels or creams) were able to alleviate vaginal dryness and dyspareunia, with intravaginal dehydroepiandrosterone (DHEA) (6.5 mg) gel showing evidence of improved sexual function. Evidence for estriol-lactobacilli vaginal tablets was unreliable due to a small-scale study. Psychoeducational therapy (internet-based cognitive behavioral therapy [CBT]) studies typically were at high risk of bias, but all displayed significant improvements of sexual function. Both laser therapy (fractional CO2 and erbium) and multimodal approach studies were at concerning risk of bias, although suggesting beneficial effects on sexual function. Conclusions and Relevance: The most reliable evidence for improvement was from a study of DHEA vaginal gel, but in general, gels or creams were useful in reducing dyspareunia. Pharmacological, psychoeducational, laser therapy, and multimodal approaches demonstrated potential in managing cancer-related sexual issues, but most were small in size (10-70 participants), with moderate to high risk of bias. Therefore, large-scale, double-blind, RCTs with long-period follow-up, and at low risk of bias are needed to show efficacy for these interventions.
... Breast cancer Pelvic floor rehabilitation [90] Colorectal cancer Dilator therapy [96] Gynecologic cancers (all) Dilator therapy [96] Pelvic floor rehabilitation [97,98] Vasomotor symptoms of menopause ...
... Yang et al. evaluated a pelvic rehabilitation program in gynecologic cancer survivors, consisting of an exercise training session with biofeedback and core strengthening, in combination with weekly counseling, which resulted in significant improvement in pelvic floor strength and numerous sexual function domains (n = 24) [97]. Similar findings, again for gynecologic cancer survivors, were observed by Cyr et al. [98]. Additionally, this study assessed feasibility and satisfaction and found excellent adherence (88%) and patient satisfaction, with 90% of participants reporting "much" or "very much" improvement. ...
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Sexual health concerns, both physical and psychological, are common and represent an unmet need among women with and surviving cancer. Sexual challenges and conditions negatively impact body image, satisfaction, relationships, well-being, and quality of life, yet are widely reported to be under-recognized and undertreated. To guide clinical care and future research on sexual function in women with cancer, we performed a scoping review of interventions for sexual health concerns, including sexual function, body image, genitourinary symptoms, and hot flashes. Relevant publications between 2005 and 2020 were identified by searching PubMed with a combination of medical subject headings and keywords. Articles were included if they focused on the aforementioned topics, were primary research publications, and included female cancer survivors. Studies focusing on women receiving hormone therapy for breast cancer were also included. A total of 91 investigations conducted in the US and abroad were reviewed. Most commonly, interventions included a component of psychoeducation, although pharmacologic, exercise, and other approaches have been evaluated. Many studies have focused on survivors of breast or gynecologic cancer, among other sampling and methodological limitations. These limitations underscore the need for more work on this vital survivorship issue. Recommendations for future research in this area are also offered.
... The most common recommendation addressed in the reviewed papers was the provision of self-management and quality resources for patients (CCO-15, A-6, B-1). This was addressed fully or partially in 16 (38%) of the included studies [15,[21][22][23]26,29,30,32,34,36,37,46,49,51,53,56]. Three recommendations were equally addressed in the reviewed papers: 'to support healthy behaviours (B-1)' [17,23,[28][29][30]34,37,50,52,53]; to provide 'variable delivery of supportive care and information (CCO-14)' [14,22,27,37,38,45,46,52,56,57]; and 'treatment summary, follow-up plan and contacts given to patient (CCO-4, A-3)' [15,17,18,21,22,26,[51][52][53]55]. ...
... This was addressed fully or partially in 16 (38%) of the included studies [15,[21][22][23]26,29,30,32,34,36,37,46,49,51,53,56]. Three recommendations were equally addressed in the reviewed papers: 'to support healthy behaviours (B-1)' [17,23,[28][29][30]34,37,50,52,53]; to provide 'variable delivery of supportive care and information (CCO-14)' [14,22,27,37,38,45,46,52,56,57]; and 'treatment summary, follow-up plan and contacts given to patient (CCO-4, A-3)' [15,17,18,21,22,26,[51][52][53]55]. These recommendations were each reflected in 10 (24%) of the included papers (Table S4). ...
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(1) Background: One in two Canadians will be diagnosed with cancer in their lifetime, but as a result of the progress in diagnosis and treatment, more individuals are surviving cancer than ever before. However, the impact of cancer does not end with treatment. The objectives of this review are to (1) provide a broad overview of the supportive care interventions and models of care that have been researched to support Canadian post-treatment cancer survivors; and (2) analyze how these supportive care interventions and/or care models align with the practice recommendations put forth by Cancer Care Ontario (CCO) and the Canadian Association of Psychosocial Oncology/Canadian Partnership Against Cancer (CAPO/CPAC). (2) Methods: An electronic search was completed in MEDLINE, Embase, PsycINFO, and CINAHL in January 2021. Included studies described supportive care interventions or models of care utilized by adult Canadian cancer survivors. (3) Results: Forty-two articles were included. Survivors utilized a multitude of supportive care interventions, with peer support and physical activity programs being most frequently cited. Four models of follow-up care were identified: primary care, oncology care, shared-care, and transition clinics. The supportive care interventions and models of care variably aligned with the recommendations set by CCO and CAPO/CPAC. The most commonly followed recommendation was the promotion of self-management and quality resources for patients. (4) Conclusions: Results indicate an inconsistency in access to supportive care interventions and the delivery of survivorship care for cancer survivors across Canada. Current efforts are being made to implement the recommendations by CCO and CAPO/CPAC; however, provision of these guidelines remains varied.
... 155 Referral to pelvic floor physical therapy is essential to optimize quality of life in the survivorship phase of these patients' care. 156 Male Spermatogenesis is impaired by very low RT doses, with immature spermatogonia the most radiosensitive, followed by spermatocytes and spermatids. Because of the theoretical risk of embryologic abnormalities from fertilization by genetically compromised sperm, many practitioners recommend against conception during and for up to 1 or 2 years after pelvic RT. 157 Permanent infertility may occur at testicular doses >6 Gy, with lower doses leading to temporary azoospermia lasting months to years. ...
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Radiation therapy (RT) is a curative treatment for many malignancies and provides effective palliation in patients with tumor‐related symptoms. However, the biophysical effects of RT are not specific to tumor cells and may produce toxicity due to exposure of surrounding organs and tissues. In this article, the authors review the clinical context, pathophysiology, risk factors, presentation, and management of RT side effects in each human organ system. Ionizing radiation works by producing DNA damage leading to tumor death, but effects on normal tissue may result in acute and/or late toxicity. The manifestation of toxicity depends on both cellular characteristics and affected organs' anatomy and physiology. There is usually a direct relationship between the radiation dose and volume to normal tissues and the risk of toxicity, which has led to guidelines and recommended dose limits for most tissues. Side effects are multifactorial, with contributions from baseline patient characteristics and other oncologic treatments. Technological advances in recent decades have decreased RT toxicity by dramatically improving the ability to deliver RT that maximizes tumor dose and minimizes organ dose. Thus the study of RT‐associated toxicity is a complex, core component of radiation oncology training that continues to evolve alongside advances in cancer management. Because RT is used in up to one‐half of all patients with cancer, an understanding of its acute and late effects in different organ systems is clinically pertinent to both oncologists and nononcologists.
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IntroductionThe present study aims to describe: 1. How the side effects of radiotherapy (RT) could impact sexual health in women; 2. The effectiveness of physical rehabilitation including pelvic floor muscle training (PFMT) in the management of sexual dysfunction after RT.Materials and Methods Search keys on PubMed, Web of Science, Scopus, PEDro, and Cochrane were used to identify studies on women treated with radical or adjuvant RT and/or brachytherapy for gynecological cancers with an emphasis on vulvo-vaginal toxicities and PFMT studies on sexual dysfunction for this group of women.ResultsRegarding the first key question, we analyzed 19 studies including a total of 2,739 women who reported vaginal dryness, stenosis, and pain as the most common side effects. Reports of dosimetric risk factors and dose-effect data for vaginal and vulvar post-RT toxicities are scant. Only five studies, including three randomized controlled trials (RCTs), were found to report the effect of PFMT alone or in combination with other treatments. The results showed some evidence for the effect of training modalities including PFMT, but to date, there is insufficient evidence from high-quality studies to draw any conclusion of a possible effect.Conclusions Gynecological toxicities after RT are common, and their management is challenging. The few data available for a rehabilitative approach on post-actinic vulvo-vaginal side effects are encouraging. Large and well-designed RCTs with the long-term follow-up that investigate the effect of PFMT on vulvo-vaginal tissues and pelvic floor muscle function are needed to provide further guidance for clinical management.
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Background A large proportion of gynecological cancer survivors suffer from pain during sexual intercourse, also known as dyspareunia. Following a multimodal pelvic floor physical therapy (PFPT) treatment, a reduction in pain and improvement in psychosexual outcomes were found in the short term, but no study thus far has examined whether these changes are sustained over time. Purpose To examine the improvements in pain, sexual functioning, sexual distress, body image concerns, pain anxiety, pain catastrophizing, painful intercourse self-efficacy, depressive symptoms and pelvic floor disorder symptoms in gynecological cancer survivors with dyspareunia after PFPT, and to explore women’s perceptions of treatment effects at one-year follow-up. Methods This mixed-method study included 31 gynecological cancer survivors affected by dyspareunia. The women completed a 12-week PFPT treatment comprising education, manual therapy and pelvic floor muscle exercises. Quantitative data were collected using validated questionnaires at baseline, post-treatment and one-year follow-up. As for qualitative data, semi-structured interviews were conducted at one-year follow-up to better understand women’s perception and experience of treatment effects. Results Significant improvements were found from baseline to one-year follow-up on all quantitative outcomes ( P ≤ 0.028). Moreover, no changes were found from post-treatment to one-year follow-up, supporting that the improvements were sustained at follow-up. Qualitative data highlighted that reduction in pain, improvement in sexual functioning and reduction in urinary symptoms were the most meaningful effects perceived by participants. Women expressed that these effects resulted from positive biological, psychological and social changes attributable to multimodal PFPT. Adherence was also perceived to influence treatment outcomes. Conclusions Findings suggest that the short-term improvements following multimodal PFPT are sustained and meaningful for gynecological cancer survivors with dyspareunia one year after treatment.
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Background: Responder analyses are used to determine whether changes that occur during a clinical trial are clinically meaningful; for subjective endpoints such as those based on patient-reported outcomes (PROs), responder analyses are particularly useful. Aim: To identify the minimal clinically important difference (MCID) for selected scores on questionnaires assessing female sexual functioning and to use these differences to analyze the response in a large, controlled, phase 2b, dose-finding study of bremelanotide in premenopausal women with hypoactive sexual desire disorder (HSDD) and mixed HSDD/female sexual arousal disorder (FSAD). Methods: The responder analyses were performed for the change from baseline to end of study for a total of 7 endpoints. Each PRO endpoint was assessed using at least 1 of 4 types of responder analyses: a planned analysis anchored to MCIDs based on expert estimates (historical anchors); post hoc analyses based on self-reported global benefit; receiver operating characteristic (ROC) curves; and cumulative distribution function. The prespecified analysis groups were all female sexual dysfunction (FSD)-based diagnoses (all study participants), those with HSDD alone, and a combined group of those with FSAD alone plus those with mixed HSDD/FSAD. Post hoc analyses were also performed for subjects with mixed HSDD/FSAD with a primary diagnosis of HSDD. Outcomes: MCIDs based on the ROC curves for changes in Female Sexual Function Index-desire domain, Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) total score, FSDS-DAO item 13 and 14 scores, and number of satisfying sexual events. Results: Outcomes matched those based on input from clinical experts. For all 7 endpoints, responder rates at the 1.75 mg dose in the overall modified intention-to-treat population achieved statistical significance compared with placebo (P ≤ .03). Clinical implications: These responder definitions were subsequently used in the bremelanotide phase 3 registration studies (RECONNECT) that evaluated the safety and efficacy of the bremelanotide 1.75 mg subcutaneous dose in premenopausal women with HSDD. Strengths & limitations: MCIDs for this study were based on changes from a single-blind phase to account for changes due to the placebo effect. These analyses were restricted to a study population composed only of premenopausal women with a clinical diagnosis of HSDD and/or FSAD and were based on data from the same clinical trial. Conclusion: Bremelanotide was safe and well tolerated and demonstrated significant improvement in efficacy vs placebo in the phase 2b trial. The multiple responder analyses offer a valuable approach for determining clinically important effects of bremelanotide for HSDD and FSAD. Althof S, Derogatis LR, Greenberg S, et al. Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide. J Sex Med 2019;16:1226-1235.
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Purpose The adaptation of the Cancer Care Ontario (CCO) guideline Interventions to Address Sexual Problems in People With Cancer provides recommendations to manage sexual function adverse effects that occur as a result of cancer diagnosis and/or treatment. Methods ASCO staff reviewed the guideline for developmental rigor and updated the literature search. An ASCO Expert Panel ( Table A1 ) was assembled to review the guideline content and recommendations. Results The ASCO Expert Panel determined that the recommendations from the 2016 CCO guideline are clear, thorough, and based upon the most relevant scientific evidence. ASCO statements and modifications were added to adapt the CCO guideline for a broader audience. Recommendations It is recommended that there be a discussion with the patient, initiated by a member of the health care team, regarding sexual health and dysfunction resulting from cancer or its treatment. Psychosocial and/or psychosexual counseling should be offered to all patients with cancer, aiming to improve sexual response, body image, intimacy and relationship issues, and overall sexual functioning and satisfaction. Medical and treatable contributing factors should be identified and addressed first. In women with symptoms of vaginal and/or vulvar atrophy, lubricants in addition to vaginal moisturizers may be tried as a first option. Low-dose vaginal estrogen, lidocaine, and dehydroepiandrosterone may also be considered in some cases. In men, medication such as phosphodiesterase type 5 inhibitors may be beneficial, and surgery remains an option for those with symptoms or treatment complications refractory to medical management. Both women and men experiencing vasomotor symptoms should be offered interventions for symptomatic improvement, including behavioral options such as cognitive behavioral therapy, slow breathing and hypnosis, and medications such as venlafaxine and gabapentin.Additional information is available at: www.asco.org/survivorship-guidelines and www.asco.org/guidelineswiki .
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Background and objectives: To ensure the effectiveness of Physical Therapy for urinary incontinence (UI), it is crucial that patients adhere to treatment in both the long and the short term. Treatment adherence may prevent symptom progression and the need for surgery, which is associated with higher costs and potential complications. Adherence is defined as carrying out a recommended behavioral modification or change. The World Health Organization (WHO) has established that adherence is a multifactorial phenomenon determined by the interaction of five dimensions, which include diverse factors that affect long-term adherence on many levels. Aim: To identify the factors that influence long-term adherence to pelvic floor exercises in women with UI. Methods: Observational, descriptive, cross-sectional study. The sample was recruited from the "Centro Integral de Reeducación de Piso Pélvico" (CIREP), and included 61 women treated for UI at the center in 2014 and 2015. Participants completed a self-administered, 28-item questionnaire developed for this study based on the WHO five dimensions. Data analysis was performed using STATA 13.0 software. Results: Having performed pelvic floor home exercises after discharge from Physical Therapy was significantly associated with self-rated treatment adherence (P < 0.001). Patient-related factors were significantly associated with long-term adherence to the pelvic floor exercise program (P < 0.001). Conclusion: Patient-related factors, exerted the strongest influence on long-term adherence to pelvic floor exercises in women with UI; forgetting to do the exercises and boredom with the exercises were the factors most strongly related to low treatment adherence, while motivation and commitment were associated with high adherence in this population.
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Background It is increasingly acknowledged that ‘acceptability’ should be considered when designing, evaluating and implementing healthcare interventions. However, the published literature offers little guidance on how to define or assess acceptability. The purpose of this study was to develop a multi-construct theoretical framework of acceptability of healthcare interventions that can be applied to assess prospective (i.e. anticipated) and retrospective (i.e. experienced) acceptability from the perspective of intervention delivers and recipients. Methods Two methods were used to select the component constructs of acceptability. 1) An overview of reviews was conducted to identify systematic reviews that claim to define, theorise or measure acceptability of healthcare interventions. 2) Principles of inductive and deductive reasoning were applied to theorise the concept of acceptability and develop a theoretical framework. Steps included (1) defining acceptability; (2) describing its properties and scope and (3) identifying component constructs and empirical indicators. ResultsFrom the 43 reviews included in the overview, none explicitly theorised or defined acceptability. Measures used to assess acceptability focused on behaviour (e.g. dropout rates) (23 reviews), affect (i.e. feelings) (5 reviews), cognition (i.e. perceptions) (7 reviews) or a combination of these (8 reviews).From the methods described above we propose a definition: Acceptability is a multi-faceted construct that reflects the extent to which people delivering or receiving a healthcare intervention consider it to be appropriate, based on anticipated or experienced cognitive and emotional responses to the intervention. The theoretical framework of acceptability (TFA) consists of seven component constructs: affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy. Conclusion Despite frequent claims that healthcare interventions have assessed acceptability, it is evident that acceptability research could be more robust. The proposed definition of acceptability and the TFA can inform assessment tools and evaluations of the acceptability of new or existing interventions.
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Purpose: Although vaginal dilator use after combined pelvic radiation therapy and brachytherapy (RT/BT) is recommended to prevent vaginal shortening and stenosis, women fail to use them and experience sexual problems. A nurse-led sexual rehabilitation intervention targeting sexual recovery and vaginal dilatation was developed. Its feasibility was investigated during a prospective, longitudinal, observational pilot study. Methods: Four oncology nurses were specifically trained to conduct the intervention. Gynecologic cancer patients treated with RT/BT were assessed using (i) questionnaires on frequency of dilator use (monthly), sexual functioning, and sexual distress (at baseline and 1, 6, and 12 months) and psychological and relational distress (at 1, 6, and 12 months); (ii) semi-structured interviews (between 6 and 12 months); and (iii) consultation recordings (a random selection of 21 % of all consults). Results: Twenty participants were 26-71 years old (mean = 40). Eight participants discontinued participation after 3 to 9 months. At 6 months after RT, 14 out of 16 (88 %), and at 12 months 9 out of 12 (75 %), participants dilated regularly, either by having sexual intercourse or by using dilators. Sexual functioning improved between 1 and 6 months after RT, with further improvement at 12 months. Most participants reported that the intervention was helpful and the nurses reported having sufficient expertise and counseling skills. Conclusions: According to the pilot results, the intervention was feasible and promising for sexual rehabilitation and regular dilator use after RT. Its (cost-)effectiveness will be investigated in a randomized controlled trial.
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The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply. The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist. The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number. This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improve
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The Female Sexual Function Index (FSFI) is a brief multidimensional scale for assessing sexual function in women. The scale has received initial psychometric evaluation, including studies of reliability, convergent validity, and discriminant validity (Meston, 2003; Rosen et al., 2000). The present study was designed to crossvalidate the FSFI in several samples of women with mixed sexual dysfunctions (N = 568) and to develop diagnostic cut-off scores for potential classification of women's sexual dysfunction. Some of these samples were drawn from our previous validation studies (N = 414), and some were added for purposes of the present study (N = 154). The combined data set consisted of multiple samples of women with sexual dysfunction diagnoses (N = 307), including female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), female sexual orgasm disorder (FSOD), dyspareunia/vaginismus (pain), and multiple sexual dysfunctions, in addition to a large sample of nondysfunctional controls (n = 261). We conducted analyses on the individual and combined samples, including replicating the original factor structure using principal components analysis with varimax rotation. We assessed Cronbach's alpha (internal reliability) and interdomain correlations and tested discriminant validity by means of a MANOVA (multivariate analysis of variance; dysfunction diagnosis x FSFI domain), with Bonferroni-corrected post hoc comparisons. We developed diagnostic cut off scores by means of standard receiver operating characteristics-curves and the CART (Classification and Regression Trees) procedure. Principal components analysis replicated the original five-factor structure, including desire/arousal, lubrication, orgasm, pain, and satisfaction. We found the internal reliability for the total FSFI and six domain scores to be good to excellent, with Cronbach alpha's >0.9 for the combined sample and above 0.8 for the sexually dysfunctional and nondysfunctional samples, independently. Discriminant validity testing confirmed the ability of both total and domain scores to differentiate between functional and nondysfunctional women. On the basis of sensitivity and specificity analyses and the CART procedure, we found an FSFI total score of 26.55 to be the optimal cut score for differentiating women with and without sexual dysfunction. On the basis of this cut-off we found 70.7% of women with sexual dysfunction and 88.1% of the sexually functional women in the cross-validation sample to be correctly classified. Addition of the lubrication score in the model resulted in slightly improved specificity (from .707 to .772) at a slight cost of sensitivity (from .881 to .854) for identifying women without sexual dysfunction. We discuss the results in terms of potential strengths and weaknesses of the FSFI, as well in terms of further clinical and research implications.
Article
Objective More than half of gynecological cancer survivors are affected by pain during sexual intercourse, also known as dyspareunia. Oncological treatments may result in pelvic floor muscle (PFM) alterations, which are suspected to play a key role in dyspareunia. However, to date, no study has investigated PFM function and morphometry in this population. The aim of the study was to characterize and compare PFM function and morphometry between gynecological cancer survivors with dyspareunia and asymptomatic women. Methods Twenty-four gynecological cancer survivors with dyspareunia and 32 women with a history of total hysterectomy but without pelvic pain (asymptomatic women) participated in this comparative cross-sectional study. PFM passive forces (tone), flexibility, stiffness, maximal strength, coordination and endurance were assessed with an intra-vaginal dynamometric speculum. Bladder neck position, levator plate angle, anorectal angle and levator hiatal dimensions were measured at rest and on maximal contraction with 3D/4D transperineal ultrasound imaging. Results Compared to asymptomatic women, gynecological cancer survivors showed heightened PFM tone, lower flexibility, higher stiffness, lower coordination and endurance (p ˂ .03). At rest, they had a smaller anorectal angle and smaller levator hiatal dimensions (p ˂ .05), indicating heightened PFM tone. They also presented fewer changes from rest to maximal contraction for anorectal angle and levator hiatal dimensions (p ˂ .03), suggesting an elevated tone or altered contractile properties. Conclusions Gynecological cancer survivors with dyspareunia present with altered PFM function and morphometry. This research provides therefore a better understanding of the underlying mechanisms of dyspareunia in cancer survivors. Impact Our study confirms alterations in PFM function and morphometry in gynecological cancer survivors with dyspareunia. These findings support the rationale for developing and assessing the efficacy of physical therapy targeting PFM alterations in this population.
Article
Objective: The aim of this systematic review was to identify, evaluate and synthesize the evidence from studies that have investigated the effect of nonsurgical, nonpharmacological, pelvic floor muscle interventions on any type of pelvic floor dysfunction or health-related quality of life in patients after any type of treatment for gynecological cancer. Methods: Six electronic databases (Cochrane Library 2018, CINAHL 1982-2018, MEDLINE 1950-2018, EMBASE 1980-2018, PsycINFO 1806-2018, and EMCARE 1995-2018) were systematically searched in June 2018. Reference lists of identified articles were hand searched. Randomized controlled trials (RCTs), cohort studies, and case series were included if they investigated the effects of conservative treatments, including pelvic floor muscle training or dilator training, on bladder, bowel or sexual function in patients who had received treatment for gynecological cancer. Risk of bias was assessed using the Physiotherapy Evidence Database (PEDro) scale for RCTs and the Newcastle-Ottawa scale for cohort studies. Results: Five RCTs and 2 retrospective cohort studies were included (n = 886). The results provided moderate-level evidence that pelvic floor muscle training with counseling and yoga or core exercises were beneficial for sexual function (SMD = -0.96, 95% CI = -1.22 to -0.70, I2 = 0%) and health-related quality of life (SMD = 0.63, 95% CI = 0.38 to 0.88, I2 = 0%) in survivors of cervical cancer, and very low-level evidence that dilator therapy reduced vaginal complications in survivors of cervical and uterine cancer (odds ratio [OR] = 0.37, 95% CI = 0.17 to 0.80, I2 = 54%). There were insufficient data for meta-analysis of bladder or bowel function. Conclusion: Conservative pelvic floor muscle interventions may be beneficial for improving sexual function and health-related quality of life in survivors of gynecological cancer. Given the levels of evidence reported in this review, further high-quality studies are needed, especially to investigate effects on bladder and bowel function. Impact: This review provides moderate level evidence for the role of pelvic floor rehabilitation to improve health outcomes in the gynecological cancer survivorship journey. Clinicians and health services should consider how to provide cancer survivors the opportunity to participant in supervised pelvic floor rehabilitation programs.
Article
Objective: To estimate the minimum clinically important difference (MCID) of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and the International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) using both anchor-based and distribution-based methods for women with stress urinary incontinence undergoing nonsurgical treatment. Materials and methods: Data from a randomized clinical trial evaluating efficacy of a nonsurgical intervention in women with stress urinary incontinence were used for analyses. The overall score of ICIQ-UI SF ranges from 0 to 21, with greater values indicating increased severity. The ICIQ-LUTSqol ranges from 19 to 76, with greater values indicating increased impact on quality of life. Instruments used in the anchor-based method were the Patient Global Impression of Improvement, patient satisfaction, 1-hour pad test and the incontinence episode frequency. The distribution-based method used an effect size of 0.5 standard deviation. Triangulation of findings was used to converge on a single value of MCID. Results: At 12-month post-treatment, 106 (88.3%) participants completed the follow-up and were included in the analysis. Anchor-based MCIDs of the ICIQ-UI SF were between 3.4 and 4.4, while the distribution-based MCID was 1.7. Anchor-based MCIDs of the ICIQ-LUTSqol were between 4.8 and 6.9, while the distribution-based MCID was 5.2. Triangulation of findings showed that MCIDs of 4 for ICIQ-UI SF and 6 for ICIQ-LUTSqol were the most appropriate. Conclusion: For women undergoing nonsurgical treatments for incontinence, reductions of 4 and 6 points in ICIQ-UI SF and ICIQ-LUTSqol, respectively are perceived as clinically meaningful.
Article
Purpose: Guidelines for the care of women undergoing pelvic radiation therapy (RT) recommend vaginal dilator therapy (VDT) to prevent radiation-induced vaginal stenosis (VS); however, no standard protocol exists. This review seeks to update our current state of knowledge concerning VS and VDT in radiation oncology. Methods and materials: A comprehensive literature review (1972-2017) was conducted using search terms "vaginal stenosis," "radiation," and "vaginal dilator." Information was organized by key concepts including VS definition, time course, pathophysiology, risk factors, and interventions. Results: VS is a well-described consequence of pelvic RT, with early manifestations and late changes evolving over several years. Strong risk factors for VS include RT dose and volume of vagina irradiated. Resultant vaginal changes can interfere with sexual function and correlational studies support the use of preventive VDT. The complexity of factors that drive noncompliance with VDT is well recognized. There are no prospective data to guide optimal duration of VDT, and the consistency with which radiation oncologists monitor VS and manage its consequences is unknown. Conclusions: This review provides information concerning VS definition, pathophysiology, and risk factors and identifies domains of VDT practice that are understudied. Prospective efforts to monitor and measure outcomes of patients who are prescribed VDT are needed to guide practice.
Article
Background: Sexual dysfunction is a distressing long-term effect after gynecological cancer and affects the majority of survivors for years after the completion of therapy. Despite its prevalence, treatment-related sexual dysfunction is underrecognized and undertreated for survivors. Thus, the aim of this study was to develop and test a brief psychoeducational intervention for managing sexual dysfunction for women who have undergone treatment for ovarian cancer (OC). Methods: Forty-six OC survivors with documented, treatment-related sexual dysfunction received a single half-day group intervention that included sexual health education and rehabilitation training, relaxation and cognitive behavioral therapy skills to address sexual symptoms, and a single tailored booster telephone call 4 weeks after the group. Assessment measures were completed at the baseline (baseline 1), after an 8-week no-treatment run-in period (baseline 2), and then again 2 and 6 months after the intervention. The Female Sexual Function Index (FSFI) was used to assess sexual functioning, and the Brief Symptom Inventory 18 (BSI-18) was used to capture psychological distress. Results: Between baseline 1 and baseline 2, there were no significant changes in the study measures, and this indicated no natural improvement during the run-in period. In contrast, the total FSFI scores improved significantly from baseline 1 to the 2- (n = 45; P < .0005) and 6-month time points (n = 42; P < .05). The BSI-18 scores were also significantly improved at the 2- (P < .005) and 6-month time points (P < .01) in comparison with baseline 1. Conclusions: This brief behavioral intervention led to significant improvements in overall sexual functioning and psychological distress that were maintained at the 6-month follow-up. The results demonstrate the feasibility of this brief, low-intensity behavioral intervention and support the development of a larger randomized controlled trial. Cancer 2018;124:176-82. © 2017 American Cancer Society.
Article
Introduction: Pelvic floor muscle physical therapy is recommended in clinical guidelines for women with provoked vestibulodynia (PVD). Including isolated or combined treatment modalities, physical therapy is viewed as an effective first-line intervention, yet no systematic review concerning the effectiveness of physical therapy has been conducted. Aim: To systematically appraise the current literature on the effectiveness of physical therapy modalities for decreasing pain during intercourse and improving sexual function in women with PVD. Methods: A systematic literature search using PubMed, Scopus, CINHAL, and PEDro was conducted until October 2016. Moreover, a manual search from reference lists of included articles was performed. Ongoing trials also were reviewed using clinicaltrial.gov and ISRCTNregistry. Randomized controlled trials, prospective and retrospective cohorts, and case reports evaluating the effect of isolated or combined physical therapy modalities in women with PVD were included in the review. Main outcome measures: Main outcome measures were pain during intercourse, sexual function, and patient's perceived improvement. Results: The literature search resulted in 43 eligible studies including 7 randomized controlled trials, 20 prospective studies, 5 retrospective studies, 6 case reports, and 6 study protocols. Most studies had a high risk of bias mainly associated with the lack of a comparison group. Another common bias was related to insufficient sample size, non-validated outcomes, non-standardized intervention, and use of other ongoing treatment. The vast majority of studies showed that physical therapy modalities such as biofeedback, dilators, electrical stimulation, education, multimodal physical therapy, and multidisciplinary approaches were effective for decreasing pain during intercourse and improving sexual function. Conclusion: The positive findings for the effectiveness of physical therapy modalities in women with PVD should be investigated further in robust and well-designed randomized controlled trials. Morin M, Carroll M-S, Bergeron S. Systematic Review of the Effectiveness of Physical Therapy Modalities in Women With Provoked Vestibulodynia. Sex Med Rev 2017;X:XXX-XXX.
Article
This review is an abbreviated version of a report prepared for the American Cancer Society Global Health department and EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, which was released at the Union for International Cancer Control World Cancer Congress in Paris in November 2016. The original report can be found at https://www.cancer.org/health-care-professionals/our-global-health-work/global-cancer-burden/global-burden-of-cancer-in-women.html. Staff in the Intramural Research Department of the American Cancer Society designed and conducted the study, including analysis, interpretation, and presentation of the review. The funding sources had no involvement in the study design, data analysis and interpretation, or preparation of the review. There are striking disparities in the global cancer burden in women, yet few publications highlight cancer occurrence in this population, particularly for cancers that are not sex specific. This article, the first in a series of two, summarizes the current burden, trends, risk factors, prevention, early detection, and survivorship of all cancers combined and seven sites (breast, cervix, uterine corpus, ovary, colorectum, lung, and liver) that account for about 60% of the cancer burden among women worldwide, using data from the International Agency for Research on Cancer. Estimated 2012 overall cancer death rates in general are higher among women in low- and middle-income countries (LMICs) than high-income countries (HICs), despite their lower overall incidence rates, largely due to inadequate access to early detection and treatment. For example, the top mortality rates are in Zimbabwe (147 deaths per 100,000) and Malawi (138). Furthermore, incidence rates of cancers associated with economic development (e.g., lung, breast, colorectum) are rising in several LMICs. The burden of cancer among women could be substantially reduced in both HICs and LMICs through broad and equitable implementation of effective interventions, including tobacco control, HPV and HBV vaccination, and screening (breast, cervix, and colorectum). Cancer Epidemiol Biomarkers Prev; 26(4); 444–57. ©2017 AACR. See related article by Islami et al. in this section, “Global Cancer in Women.”
Article
As cancer therapies improve, the number of women surviving or living long lives with cancer continues to increase. Treatment modalities, including surgery, chemotherapy, radiotherapy, and hormonal therapy, affect sexual function and may cause sexual pain through a variety of mechanisms, depending on treatment type. Adverse sexual effects resulting from ovarian damage, anatomic alterations, and neurologic, myofascial, or pelvic organ injury may affect more than half of women affected by cancer. Despite the fact that no specialty is better qualified to render care for this consequence of cancer treatments, many obstetrician-gynecologists (ob-gyns) feel uncomfortable or ill-equipped to address sexual pain in women affected by cancer. Asking about sexual pain and dyspareunia and performing a thorough physical examination are essential steps to guide management, which must be tailored to individual patient goals. Understanding the cancer treatment-related pathophysiology of sexual pain aids in providing this care. Effective mechanism-based treatments for sexual pain and dyspareunia are available, and by using them, knowledgeable ob-gyns can enhance the quality of life of potentially millions of women affected by cancer.
Article
Answer questions and earn CME/CNE Sexual concerns are prevalent in women with cancer or cancer history and are a factor in patient decision making about cancer treatment and risk-reduction options. Physical examination of the female cancer patient with sexual concerns, regardless of the type or site of her cancer, is an essential and early component of a comprehensive evaluation and effective treatment plan. Specialized practices are emerging that focus specifically on evaluation and treatment of women with cancer and sexual function problems. As part of a specialized evaluation, oncologists and their patients should expect a thorough physical examination to identify or rule out physical causes of sexual problems or dysfunction. This review provides oncology professionals with a description of the physical examination of the female cancer patient with sexual function concerns. This description aims to inform anticipatory guidance for the patient and to assist in interpreting specialists' findings and recommendations. In centers or regions where specialized care is not yet available, this review can also be used by oncology practices to educate and support health care providers interested in expanding their practices to treat women with cancer and sexual function concerns. CA Cancer J Clin 2016. © 2016 American Cancer Society.
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Objective: The diagnosis and treatment of gynecologic cancer can cause short- and long-term negative effects on sexual health and quality of life (QoL). The aim of this article is to present a comprehensive overview of the sexual health concerns of gynecologic cancer survivors and discuss evidence-based treatment options for commonly encountered sexual health issues. Methods: A comprehensive literature search of English language studies on sexual health in gynecologic cancer survivors and the treatment of sexual dysfunction was conducted in MEDLINE databases. Relevant data are presented in this review. Additionally, personal and institutional practices are incorporated where relevant. Results: Sexual dysfunction is prevalent among gynecologic cancer survivors as a result of surgery, radiation, and chemotherapy-negatively impacting QoL. Many patients expect their healthcare providers to address sexual health concerns, but most have never discussed sex-related issues with their physician. Lubricants, moisturizers, and dilators are effective, simple, non-hormonal interventions that can alleviate the morbidity of vaginal atrophy, stenosis, and pain. Pelvic floor physical therapy can be an additional tool to address dyspareunia. Cognitive behavioral therapy has been shown to be beneficial to patients reporting problems with sexual interest, arousal, and orgasm. Conclusion: Oncology providers can make a significant impact on the QoL of gynecologic cancer survivors by addressing sexual health concerns. Simple strategies can be implemented into clinical practice to discuss and treat many sexual issues. Referral to specialized sexual health providers may be needed to address more complex problems.
Article
Feasibility and pilot studies play an important role in the preliminary planning of a proposed full-size randomized clinical trial (RCT). In essence, feasibility studies are used to help develop trial interventions or outcome measures, whereas pilot studies replicate, in miniature, a planned full-size RCT. However, the terms used for these preliminary studies are sometimes considered synonymous, and in practice may overlap considerably or be combined. The important issue is not the distinction between these: the important distinction is between such preliminary studies and a proper RCT. J Orthop Sports Phys Ther 2014;44(8):555-558. doi:10.2519/jospt.2014.0110.
Article
We previously reported high rates of urinary incontinence among gynecologic cancer survivors and aimed to evaluate the effectiveness of a simple intervention for treatment of urinary incontinence in this population. We recruited 40 gynecologic cancer survivors who reported urinary incontinence on a validated questionnaire. Women were randomized to either pelvic floor muscle training/behavioral therapy (treatment group) or usual care (control group). The primary outcome measure, assessed at 12weeks post intervention, was a 40% difference in the validated Patient Global Impression of Improvement (PGI-I) score. Fisher's exact test was used to identify differences between groups for frequency data; two-sample t-test was conducted for continuous measurements. Mean age of this cohort was 57 (range: 37-79). The majority of the survivors had uterine cancer (60%), 18% had received radiation therapy, 95% had received surgical therapy, and 35% had received chemotherapy. At three months, 80% of the treatment and 40% of the control group reported that their urinary incontinence was "much better" or "very much better" as evaluated by the Patient Global Impression of Improvement scale (p=0.02). Brink's scores were significantly improved in the treatment group as compared to controls (p<0.0001). Treatment group adherence was high; the treatment group performed exercises an average of 22days/ month. Urinary incontinence negatively affects quality of life, and despite a high prevalence among gynecologic cancer survivors, it is often under-assessed and undertreated. We found a simple intervention that included pelvic floor muscle training and behavioral therapy, significantly improved cancer survivor's urinary incontinence.
Article
To compare the efficacy and safety of sustained release (SR) formulation of pregabalin with immediate release (IR) formulation in patient with diabetic peripheral neuropathic pain. In this open label, randomized, comparative, multicentric study, the primary efficacy measure was reduction in visual analogue scale (VAS) of short form McGill pain questionnaire (SF-MPQ) score from baseline to last visit. The secondary evaluation measures included reduction in SF-MPQ descriptive score and present pain intensity score and change in clinical global impression - improvement of illness (CGI-I) and clinical global impression - severity of illness (CGI-S) from baseline to last visit. Total duration of the study was 12 weeks. Safety evaluation was done by recording treatment emergent adverse events and laboratory investigations at baseline and end of treatment. Of 265 randomized patients, 133 received pregabalin SR tablets and 132 pregabalin IR. Patients randomized to both treatments responded to respective treatments. The least square means of VAS score in both the groups were reduced significantly (P <0.01). Reduction in both groups was similar (P = ns). At the end of the trial in both the groups, there was a significant reduction in the SF-MPQ descriptive score (P <0.01), severity of illness as well as clinically significant improvement in the symptoms. Difference between the groups for CGI-I (P = 0.37) and CGI-S (P = 0.41) score was not statistically significant. Treatment in both the groups was found safe and well tolerated. The study shows that the pregabalin SR is safe and effective in patients of diabetic peripheral neuropathic pain. The results of the study demonstrated that pregabalin SR has comparable efficacy and safety as pregabalin IR.
Article
Objective (1) To explore the reasons for not seeking help for severe pelvic floor symptoms after gynaecological cancer treatment. (2) To determine the willingness to undergo treatment for these symptoms. (3) To invite suggestions to improve outpatient care. Design Qualitative study using semistructured interviews. Setting Vulvar, endometrial or cervical cancer survivors treated in the Academic Medical Centre, Amsterdam, the Netherlands between1997 and 2007. Population Purposively selected sample from 138 eligible respondents to pelvic floor-related questionnaires, who were severely bothered by their symptoms (>75th percentile of domain sum score of questionnaires) and had not sought medical help. Methods After each semistructured interview, a checklist with reasons for not seeking help was complemented with newly mentioned reasons. The interviews were stopped when data saturation was accomplished, i.e. three consecutive interviewees had not revealed new reasons. The interviews were analysed by two researchers independently. Main outcome measure Help-seeking behaviour for bothersome pelvic floor symptoms. Results Fifteen interviews were conducted. Most reported reasons for not seeking help were that women found their symptoms bearable in the light of their cancer diagnosis and lacked knowledge about possible treatments. Seven women were willing to undergo treatment. Eleven women stated that care should be improved, specifically by timely referral to pelvic floor specialists and additional care by oncology nurses. Conclusions There is a need for standardised attention to adverse effects on pelvic floor function after cancer treatment. This could be realised by quantifying symptoms using questionnaires, standardised attention for such symptoms by gynaecological oncologists or oncology nurses, and timely referral to pelvic floor specialists of women with bothersome pelvic floor symptoms.
Article
Cancer survivors face a myriad of long-term effects of their disease, diagnosis, and treatment, and chief among many are problems associated with sexual dysfunction. Yet despite their frequency and the degree of distress they cause patients, sexual dysfunction is not effectively screened for or treated, and this is particularly true in female survivors. Inconsistently performed general sexual health screening at all facets of cancer care and survivorship ultimately translates into missed attempts to identify and treat dysfunction when it does arise. In this paper, we will review the current research and clinical practices addressing sexual dysfunction in female cancer survivors and propose questions in need of future research attention. This article will review the phases of sexual response and how each may be affected by the physical and emotional stress of cancer diagnosis and treatment. We will then discuss existing tools for assessment of sexual function and approaches to their treatment. Finally, we will conclude with advice to health care professionals based on current research and suggest questions for future study.
Article
To investigate the effects of a pelvic floor rehabilitation program (PFRP) on pelvic floor function and quality of life (QoL) in gynecological cancer survivors in a prospective, randomized, controlled trial. Thirty-four patients with gynecological cancers recruited between July 2009 and December 2009 were randomly allocated into two groups: a PFRP group (n=17), who participated in a 4-week PFRP exercise program, and a non-PFRP group (n=17), who received the usual health care. The pelvic floor strength, the motor evoked potentials (MEPs) elicited by sacral and transcranial magnetic stimulation, the pelvic floor questionnaire, and the scores on two QoL questionnaires, (QLQ)-C30 and QLQ-CX 24, from the European Organization for Research and Treatment of Cancer (EORTC) were evaluated to assess changes in pelvic floor function and QoL before and after the exercise program. Twenty four patients (12 from each group) completed the exercise program. The PFRP group improved in pelvic floor strength (mean difference (MD)=14.22, t(9)=2.389, P=0.036) and sexual functioning. The PFRP group also improved in physical and sexual function compared with the non-PFRP group. The results suggest that the PFRP improved pelvic floor dysfunction and QoL of gynecological cancer patients. A larger randomized controlled trial is planned.
Article
The goal of this study was to evaluate a mindfulness-based cognitive behavioral intervention for sexual dysfunction in gynecologic cancer survivors compared to a wait-list control group. Thirty-one survivors of endometrial or cervical cancer (mean age 54.0, range 31-64) who self-reported significant and distressing sexual desire and/or sexual arousal concerns were assigned either to three, 90-minute mindfulness-based cognitive behavior therapy sessions or two months of wait-list control prior to entering the treatment arm. Validated measures of sexual response, sexual distress, and mood, as well as laboratory-evoked physiological and subjective sexual arousal were assessed at pre-, one month post-, and 6-months following treatment. There were no significant effects of the wait-list condition on any measure. Treatment led to significant improvements in all domains of sexual response, and a trend towards significance for reducing sexual distress. Perception of genital arousal during an erotic film was also significantly increased following the intervention despite no change in physiologically-measured sexual arousal. A brief mindfulness-based intervention was effective for improving sexual functioning. Geographic restrictions permitted only a select sample of survivors to participate, thus, the generalizability of the findings is limited. Future studies should aim to develop online modalities for treatment administration to overcome this limitation.
Article
To identify physical, psychological and social sexual concerns reported by gynecological (GYN) cancer survivors. A systematic review of the literature was conducted using CINAHL, PubMed and PsycInfo databases. Reference lists from articles provided additional relevant literature. Only research articles from peer-reviewed journals were included. A total of 37 articles were located; 34 explored women's sexual concerns following gynecological cancer diagnosis and treatment and 3 tested interventions for sexual concerns in women with gynecological cancer. Sexual concerns were identified across all dimensions of sexuality. Common concerns in the physical dimension were dyspareunia, changes in the vagina, and decreased sexual activity. In the psychological dimension, common concerns were decreased libido, alterations in body image, and anxiety related to sexual performance. And in the social dimension, common concerns were difficulty maintaining previous sexual roles, emotional distancing from the partner, and perceived change in the partner's level of sexual interest. Of the three psychoeducational intervention studies, two reported improvements in physical aspects of sexual function, and one reported improved knowledge, but without resolution of sexual concerns. Gynecological cancer survivors experience a broad range of sexual concerns after diagnosis and treatment, but the majority of studies emphasized physical aspects of sexuality, and may not adequately represent women's psychological and social sexual concerns. Health care providers should remain mindful of psychological and social sexual concerns when caring for gynecologic cancer survivors. Future research should systematically evaluate the full range of sexual concerns in large, representative samples of GYN cancer survivors and develop and test interventions to address those concerns.
Article
A psychometrically robust patient-completed questionnaire for anal incontinence, which reflects issues of importance to both clinicians and patients, was lacking for assessment purposes. This study aimed to determine the psychometric properties of a new questionnaire developed to address this need, the International Consultation on Incontinence Questionnaire-Bowels module. Qualitative studies were used to refine the developmental version of the questionnaire. Quantitative studies were conducted to evaluate its psychometric properties. Patients were invited to complete the questionnaire via postal administration. Two hundred sixty-one patients with known bowel symptoms participated in the study (244 females, 17 males; mean age, 59.7 years (range, 24-92)). The aspects of validity were evaluated in comparison with available evidence, responses to existing instruments, and physiological findings. Reliability was assessed through repeat administration of the questionnaire and evaluation of internal consistency by the Cronbach α coefficient. Responsiveness following treatment was evaluated by the use of the Wilcoxon signed rank test. Exploratory factor analysis was used to derive the final version of the questionnaire with evidence from the above studies. The final questionnaire contains 17 questions arranged in 3 scored domains: bowel pattern, bowel control, and quality of life, with 4 unscored items included to evaluate important issues from a clinical or patient perspective. The questionnaire demonstrated acceptable validity, "good" to "very good" reliability, and reasonable response to changes in symptom and quality-of-life status following intervention. Response rates varied according to location. The International Consultation on Incontinence Questionnaire Bowel module is a psychometrically robust, self-report instrument for the evaluation of anal incontinence and its impact on quality of life. It is suitable for use in individuals with anal incontinence of varying causes. It includes a scoring system for use in clinical practice and research.
Article
The objective of this study was to identify patterns of interest in receiving care for sexual concerns among women who were survivors of gynecologic and breast cancers. Survey and medical records data were collected from June 2008 to March 2009 from 261 gynecologic and breast cancer patients. Logistic regression was used to estimate the effect of age and months since treatment on interest in receiving sexual healthcare. The mean participant age was 55 years (range, 21-88 years). Only 7% of women had recently sought medical help for sexual issues, yet 41.6% were interested in receiving care. Greater than 30% responded that they would be likely to see a physician to address sexual matters, and 35% of all women were willing to be contacted if a formal program was offered. Compared with older women (aged >65 years), younger women (ages 18-47 years) were significantly more likely to report interest in receiving care to address sexual issues (odds ratio [OR], 2.94; 95% confidence interval [CI], 1.14-7.54) and to see a physician to address sexual matters (OR, 4.51; 95% CI, 1.51-13.43), and they were more willing to be contacted for a formal program (adjusted OR [AOR], 5.00; 95% CI, 1.63-15.28). Compared with women who were currently in treatment, women who last received treatment >12 months previously were significantly more interested in receiving care (AOR, 2.02; 95% CI, 1.02-4.01) and were more willing to be contacted (AOR, 2.49; 95% CI, 1.18-5.26). Greater than 40% of survivors expressed interest in receiving sexual healthcare, but few had ever sought such care. The current results indicated that there is an unmet need for attention to sexual concerns among women with gynecologic and breast cancers.
Article
The purpose of this study was to assess the prevalence of pelvic floor disorders and sexual function in survivors of gynecologic cancer. We surveyed survivors of gynecologic cancer (survivors) and women seeking gynecologic care (control patients) who were >30 years old. All survivors were disease- and treatment-free for ≥1 year. Validated questionnaires were used to evaluate pelvic floor disorders. One hundred eight control patient and 260 survivor questionnaires were completed. A high prevalence of pelvic floor disorders was observed in both groups; 56% of control subjects and 70% of survivors reported moderate to severe urinary incontinence (P > .05). Survivors were more likely to experience fecal incontinence (42% vs 32%; P = .02). Survivors reported less sexual desire (P = .04) and less ability to climax (P = .04), despite no difference in dyspareunia. Fecal incontinence and sexual dysfunction are significant problems in survivors of gynecologic cancer.
Article
Public health is moving toward the goal of implementing evidence-based interventions. To accomplish this, there is a need to select, adapt, and evaluate intervention studies. Such selection relies, in part, on making judgments about the feasibility of possible interventions and determining whether comprehensive and multilevel evaluations are justified. There exist few published standards and guides to aid these judgments. This article describes the diverse types of feasibility studies conducted in the field of cancer prevention, using a group of recently funded grants from the National Cancer Institute. The grants were submitted in response to a request for applications proposing research to identify feasible interventions for increasing the utilization of the Cancer Information Service among underserved populations.
Article
Pain intensity is frequently measured on an 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=worst possible pain. However, it is difficult to interpret the clinical importance of changes from baseline on this scale (such as a 1- or 2-point change). To date, there are no data driven estimates for clinically important differences in pain intensity scales used for chronic pain studies. We have estimated a clinically important difference on this scale by relating it to global assessments of change in multiple studies of chronic pain. Data on 2724 subjects from 10 recently completed placebo-controlled clinical trials of pregabalin in diabetic neuropathy, postherpetic neuralgia, chronic low back pain, fibromyalgia, and osteoarthritis were used. The studies had similar designs and measurement instruments, including the PI-NRS, collected in a daily diary, and the standard seven-point patient global impression of change (PGIC), collected at the endpoint. The changes in the PI-NRS from baseline to the endpoint were compared to the PGIC for each subject. Categories of "much improved" and "very much improved" were used as determinants of a clinically important difference and the relationship to the PI-NRS was explored using graphs, box plots, and sensitivity/specificity analyses. A consistent relationship between the change in PI-NRS and the PGIC was demonstrated regardless of study, disease type, age, sex, study result, or treatment group. On average, a reduction of approximately two points or a reduction of approximately 30% in the PI-NRS represented a clinically important difference. The relationship between percent change and the PGIC was also consistent regardless of baseline pain, while higher baseline scores required larger raw changes to represent a clinically important difference. The application of these results to future studies may provide a standard definition of clinically important improvement in clinical trials of chronic pain therapies. Use of a standard outcome across chronic pain studies would greatly enhance the comparability, validity, and clinical applicability of these studies.
Article
Objective. To provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain. Development of a core set of outcome domains would facilitate comparison and pooling of data, encourage more complete reporting of outcomes, simplify the preparation and review of research proposals and manuscripts, and allow clinicians to make informed decisions regarding the risks and benefits of treatment. Methods. Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 27 specialists from academia, governmental agencies, and the pharmaceutical industry participated in a consensus meeting and identified core outcome domains that should be considered in clinical trials of treatments for chronic pain. Conclusions. There was a consensus that chronic pain clinical trials should assess outcomes representing six core domains: (1) pain, (2) physical functioning, (3) emotional functioning, (4) participant ratings of improvement and satisfaction with treatment, (5) symptoms and
Article
To develop and validate a self-completion questionnaire for comprehensive assessment of the severity and impact of vaginal symptoms and related sexual matters, particularly those attributed to pelvic organ prolapse. To provide an instrument that can characterise the severity of these symptoms, measure their impact and evaluate treatment outcome. Prospective development of the content of the questionnaire and testing of its psychometric properties including validity. Two hospital-based urogynaecology clinics and one community general practice in the South of England. One hundred and forty-one urogynaecology clinic attendees with varying degrees of pelvic organ prolapse and 77 randomly selected women registered with a general practice. The questionnaire was developed through a literature review, consultation with clinicians and health scientists and structured interviews with patients. Content validity, construct validity, stability, internal consistency and sensitivity to change were examined by comparing the responses from the urogynaecology clinic with responses from the general community. Sensitivity to change was assessed using responses from women undergoing surgical treatment for pelvic organ prolapse before and 3 months after surgery. A final version of the questionnaire was obtained after factor analysis to assist item reduction and refinement of the scoring system. Content validity, construct validity, stability (test-retest reliability), internal consistency and sensitivity to change. The questionnaire exhibited good validity, reliability and sensitivity to change. Excellent internal consistency was demonstrated for vaginal (Cronbach's alpha 0.79) and sexual (Cronbach's alpha 0.84) symptoms. Reliability was good. The questionnaire was able to identify changes in symptoms following surgical treatment. The final ICIQ-VS questionnaire had 14 items and a simple scoring system. CONCLUSION; The ICIQ-VS self-completion questionnaire meets the need for a robust instrument for assessing a range of vaginal and sexual symptoms, in particular those of pelvic organ prolapse. It will be of use in both routine clinical practice and epidemiological research, particularly when there is a need to assess the severity of these symptoms or the efficacy of treatment.
Article
The Female Sexual Function Index (FSFI) is a very well-worded sexual function screen with excellent psychometric qualities. However, some aspects of the scoring procedures pose conceptual and statistical problems, which we illustrate in part by way of an empirical example. The recommended solutions should further strengthen the utility and validity of this instrument.
Article
Unlabelled: A consensus meeting was convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to provide recommendations for interpreting clinical importance of treatment outcomes in clinical trials of the efficacy and effectiveness of chronic pain treatments. A group of 40 participants from universities, governmental agencies, a patient self-help organization, and the pharmaceutical industry considered methodologic issues and research results relevant to determining the clinical importance of changes in the specific outcome measures previously recommended by IMMPACT for 4 core chronic pain outcome domains: (1) Pain intensity, assessed by a 0 to 10 numerical rating scale; (2) physical functioning, assessed by the Multidimensional Pain Inventory and Brief Pain Inventory interference scales; (3) emotional functioning, assessed by the Beck Depression Inventory and Profile of Mood States; and (4) participant ratings of overall improvement, assessed by the Patient Global Impression of Change scale. It is recommended that 2 or more different methods be used to evaluate the clinical importance of improvement or worsening for chronic pain clinical trial outcome measures. Provisional benchmarks for identifying clinically important changes in specific outcome measures that can be used for outcome studies of treatments for chronic pain are proposed. Perspective: Systematically collecting and reporting the recommended information needed to evaluate the clinical importance of treatment outcomes of chronic pain clinical trials will allow additional validation of proposed benchmarks and provide more meaningful comparisons of chronic pain treatments.
Sexual dysfunction in gynecologic cancer patients
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of Clinical Oncology clinical practice guideline adaptation of Cancer Care Ontario guideline
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Health research methodology: A guide for training in research methods
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