Vivian E von Gruenigen

Publications (29)97.16 Total impact

• Article: Toxicity of weekly oral topotecan in relation to dosage for gynecologic malignancies: a phase I study.

  Vivian E von Gruenigen, Heidi E Frasure, Deborah A Smith, Nancy L Fusco, Susan M Eaton, Robert L DeBernardo, Anne M Heugel, Steven E Waggoner
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  ABSTRACT: The aim of this study was to determine the dose of weekly oral topotecan that allows safe administration and to evaluate the pharmacokinetics of this dose in patients with recurrent gynecologic malignancies. The first cohort of patients received oral topotecan 6 mg/week administered orally on days 1, 8, and 15 of a 28-day regimen. A standard 3+3 dose-escalating phase design was used for dose levels II-V (8, 10, 12 and 14 mg/week). Toxicity was scored according to the Common Terminology Criteria for Adverse Events. Cumulative toxicity was summarized in the 6-12 mg/week combined cohort and 14 mg/week cohort separately. Pharmacokinetic samples were obtained for day 1, cycle 1 only in the expansion cohort (dose level V). Twenty-five patients received a total of 88 cycles of therapy. Hematologic toxicities of grade 3 (6-12 mg dose) were neutropenia (25%) and anemia (8.3%). Gastrointestinal toxicities of grade 3 were diarrhea (16.7%) and obstruction (8.3%, disease-related). Grade 3 or 4 (14 mg/week) hematologic toxicities consisted of neutropenia (38.5%), platelets (15.4%), anemia (15.4%), infection with neutropenia (7.7%), and thrombosis (7.7%). Gastrointestinal toxicities of grade 3 were diarrhea (7.7%), obstruction (7.7%), and vomiting (7.7%). One patient died secondary to neutropenic sepsis. One patient (4%; 95% confidence interval: 2.1, 22.3) showed a partial response and five patients (20%; 95% confidence interval: 7.6, 41.3) had stable disease. An oral topotecan dose of 14 mg/week for 3 consecutive weeks out of 4 is mostly associated with acceptable toxicities and may be considered for use in future single-agent phase II trials.
  Anti-cancer drugs 05/2012; 23(7):724-30. · 2.23 Impact Factor
• Article: The association between quality of life domains and overall survival in ovarian cancer patients during adjuvant chemotherapy: a Gynecologic Oncology Group Study.

  Vivian E von Gruenigen, Helen Q Huang, Karen M Gil, Heidi E Frasure, Deborah K Armstrong, Lari B Wenzel
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  ABSTRACT: To explore the association between baseline quality of life (QOL) scores and overall survival (OS) in ovarian cancer patients receiving adjuvant chemotherapy. Patients with stage III ovarian cancer on Gynecologic Oncology Group protocol #172 completed the Functional Assessment of Cancer Therapy-General (FACT-G) and were then randomly assigned to either intravenous (IV) or intraperitoneal (IP) chemotherapy. The FACT scale includes physical, functional, social, and emotional well-being domains (PWB, FWB, SWB, EWB). The PWB item, lack of energy, was used to assess the presence of fatigue. After adjusting for patient age, treatment assignment, and the presence of gross disease, PWB was associated with OS. Patients who reported baseline PWB scores in the lowest 25% (PWB score<15 points) relative to those who scored in the highest 25% (PWB score>24 points) had decreased OS (HR: 1.81; 95% CI: 1.2-2.72; p=0.005). Patients experienced death rates 20% lower for every mean item point increase in PWB (Hazard Ratio [HR]: 0.80; 95% CI: 0.68-0.93; p=0.005). Patients complaining of fatigue did not have an increased risk of death compared with those not feeling fatigued (HR: 1.21; 95% CI: 0.91-1.61; p=0.19). Poor physical well-being reported at baseline is associated with risk of death in patients undergoing adjuvant chemotherapy for advanced ovarian cancer. Identifying modifiable characteristics that are associated with survival offers the potential for providing support that may improve outcomes.
  Gynecologic Oncology 11/2011; 124(3):379-82. · 3.89 Impact Factor
• Article: The effect of sleep disturbance on quality of life in women with ovarian cancer.

  Samith Sandadi, Heidi E Frasure, Meredith J Broderick, Steven E Waggoner, Jacqualin A Miller, Vivian E von Gruenigen
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  ABSTRACT: To estimate the prevalence of sleep disturbances, and to determine if there is an association between sleep disturbances with quality of life (QOL), depression or clinical demographic variables. Patients diagnosed with ovarian, fallopian tube or primary peritoneal cancer during the last 5years completed questionnaires regarding sleep patterns and disturbances [Pittsburgh Sleep Quality Index (PSQI)], depression [Beck Depression inventory (BDI)], and QOL [The Functional Assessment of Cancer Therapy-Ovarian (FACT-O), fatigue module (-F)]. Data were analyzed by Student's t-test or Pearson correlation coefficient to determine if there were differences between PSQI score with QOL, depression or clinical demographic variables. 86/275 (31% response) of patients returned the surveys. Mean age was 58.1 (SD=14.6) years and 70% had advanced disease at diagnosis. Thirty-six percent had current disease of which 81% were receiving chemotherapy. Sixty-seven percent of patients had a PSQI score≥5 corresponding to overall poor sleep quality and 46% of patients reported using sleep medication at least once during the prior month. PSQI score was significantly inversely correlated with all QOL domains (physical: r=-.599, p<.001, functional: r=-.692, p<.001, social: r=-.212, p<.001, emotional: r=-.379, p<.001, fatigue; r=-.655 p<.001) and with depression (r=.539, p<.001). PSQI was not correlated with age, time since diagnosis, number of previous chemotherapy regimens. PSQI score did not differ by current disease or chemotherapy status. Sleep disturbances reduce QOL, a prognostic indicator for survival, in ovarian cancer patients. These patients should undergo routine screening and would benefit from interventions that aim to promote restful sleep.
  Gynecologic Oncology 08/2011; 123(2):351-5. · 3.89 Impact Factor
• Article: Feasibility of a lifestyle intervention for ovarian cancer patients receiving adjuvant chemotherapy.

  Vivian E von Gruenigen, Heidi E Frasure, Mary Beth Kavanagh, Edith Lerner, Steven E Waggoner, Kerry S Courneya
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  ABSTRACT: This study aimed to assess the feasibility of a lifestyle intervention for promoting physical activity (PA) and diet quality during adjuvant chemotherapy for ovarian cancer. Patients were enrolled post-operatively and received PA and nutrition counseling, at every chemotherapy visit for six cycles. Quality of life (QoL) was measured with the Functional Assessment of Cancer Therapy (FACT-G), PA with the Leisure Score Index (LSI), dietary intake with 3-day food records, and symptom severity/distress by the Memorial Symptom Assessment Scale (MSAS). Pedometer step count was collected during chemotherapy cycles. Recruitment was 73% with 27 patients enrolled. Mean [95% confidence interval] change in minutes of PA from cycle #3 to following cycle #6 was 61 min [-3, 120] p=0.063, and from baseline to after cycle #6 was 73 min [-10, 15]; p=0.082. Mean change in total fruit and vegetable consumption between baseline and during chemotherapy was 0.56 [-0.09, 0.64]; p=0.090. FACT-G increased from 75.4 at baseline to 77.6 during chemotherapy and 83.9 following chemotherapy (p=0.001 for change from baseline to post-chemotherapy). Mean total MSAS score was 20.6 at baseline, 26.6 at cycle #3 and decreased to 17.0 following chemotherapy (p=0.01 comparison of cycle #3 and following chemotherapy). Increased moderate to strenuous PA was correlated with higher physical well-being during chemotherapy (r=0.48, p=0.037). Lifestyle counseling during adjuvant chemotherapy for ovarian cancer is feasible and may improve PA and diet quality. Randomized controlled trials examining the effects of lifestyle counseling on quality of life and treatment outcomes in ovarian cancer patients are warranted.
  Gynecologic Oncology 05/2011; 122(2):328-33. · 3.89 Impact Factor
• Article: Health care reform: will quality remodeling affect obstetrician-gynecologists in addition to patients?

  Vivian E von Gruenigen, T Clifford Deveny
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  ABSTRACT: The Patient Protection and Affordable Care Act is a federal statute that attempts to address many fundamental problems with the current health care system including the uninsured, rising health care costs, and quality care. Quality metrics have been in development for years (by private and governmental sectors), and momentum is growing. The purpose of this commentary is to explore quality changes in the way practicing obstetricians and gynecologists will be held accountable for quality service. Two new options being explored for health care, both focusing on improving quality and physician metrics, include value-based purchasing and accountable-care organizations. Both will likely consist of universal clinical algorithms and cost monitoring as measures. For obstetrics this will probably include physician's rates of cesarean deliveries and elective inductions. For gynecology this may comprise of indications for hysterectomy with documented failed medical management, minor surgical management, or both medical and minor surgical management. It is anticipated patients will no longer be able to request obstetric testing, pregnancy induction, or hysterectomy. It is imperative we, as obstetrician-gynecologists, are involved in health care reform that inevitably involves the care of women. The expectation is that the American Congress of Obstetricians and Gynecologists (ACOG) will further develop evidenced-based opinions and guidelines, as medical communities embrace ACOG documents and reference these in hospital policies and peer review.
  Obstetrics and Gynecology 05/2011; 117(5):1167-9. · 4.73 Impact Factor
• Article: Physical activity and gynecologic cancer survivorship.

  Karen M Gil, Vivian E von Gruenigen
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  ABSTRACT: Gynecologic oncology involves the study of preinvasive disease and cancers of the vulva, vagina, cervix, uterus, ovaries, and gestational trophoblastic disease. Endometrial cancer is the most common of the pelvic malignancies however, ovarian cancer is the most lethal. The other gynecologic cancers have not been studied in relation to physical activity (PA) and prognosis, and therefore are not included. Research addressing the relationship between PA and ovarian and endometrial cancer is sparse nevertheless, there are some emerging concepts. Studies suggest that overweight/obesity is associated with reduced survival from ovarian cancer, but the role that PA plays in these results, and whether survival can be altered by changes in body weight and/or PA following diagnosis is unknown. Limited research reveals that increased PA in older ovarian cancer patients is feasible and safe. The majority of endometrial cancer patients are overweight or obese. Obesity is associated with higher mortality, probably from cardiovascular disease and not cancer. Research reveals that increasing PA in overweight/obese endometrial cancers is feasible and successful. The effects of increased PA on recurrence or survival in gynecological cancers are not yet established, and randomized controlled trials are needed for definitive data.
  Recent results in cancer research. Fortschritte der Krebsforschung. Progrès dans les recherches sur le cancer 01/2011; 186:305-15.
• Article: Lifestyle challenges in endometrial cancer survivorship.

  Vivian E von Gruenigen, Steven E Waggoner, Heidi E Frasure, Mary Beth Kavanagh, Jeffrey W Janata, Peter G Rose, Kerry S Courneya, Edith Lerner
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  ABSTRACT: To examine lifestyle behaviors that may contribute to endometrial cancer survivor morbidity and to identify associations with quality of life. Patients with early-stage (I or II) endometrial cancer with a body mass index of at least 25 kg/m2 completed questionnaires on smoking, physical activity, fruit and vegetable intake, and the Functional Assessment of Cancer Therapy (FACT) and Short-Form medical outcomes (SF-36) quality-of-life surveys. Behaviors were compared with American Cancer Society 2006 guidelines for cancer survivors (150 min/wk of moderate-to-vigorous physical activity; five servings fruit and vegetables per day; no smoking). Effect size (d) was calculated for the difference in means between meeting and not meeting guidelines (d=0.5 moderate effect). A total of 120 participants were enrolled. Of those, 43% had hypertension, 35% osteoarthritis, 33% metabolic syndrome, 21% type 2 diabetes mellitus, and 93% abdominal obesity. Only 12% of participants were meeting physical activity guidelines. Fifteen percent reported five or more servings of fruit and vegetables per day; mean intake was 2.6 servings per day. Seventy-four percent of participants were nonsmokers. Only 1% of participants met all three American Cancer Society guidelines; 22% met none of the recommendations. The emotional well-being (mean 17.4 [±4.1] compared with 20.1 [±4.1]; d=0.66) and fatigue scores (mean 34.6 [±9.5] compared with 40.5 [±9.6]; d=0.62) indicate that those who do not meet the guidelines had lower emotional well-being and increased fatigue. Endometrial cancer survivors have unhealthy lifestyles that put them at risk for morbidity. This survivor group should be offered multi-behavioral lifestyle interventions after diagnosis. ClinicalTrials.gov, www.clinicaltrials.gov, NCT 00420979 and NCT00732173. II.
  Obstetrics and Gynecology 01/2011; 117(1):93-100. · 4.73 Impact Factor
• Source

  Available from: PubMed Central

  Article: Quality of life in endometrial cancer survivors: what does obesity have to do with it?

  Amanda Nickles Fader, Heidi E Frasure, Karen M Gil, Nathan A Berger, Vivian E von Gruenigen
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  ABSTRACT: Objective. Most women with type I endometrial cancer (EC) are obese, increasing the risk of morbidity and mortality in this population. The study objective was to evaluate the impact of obesity on quality of life (QOL) and general health status in EC survivors with early-stage disease. Methods. A prospective ancillary analysis of stage I/II EC survivors. The association of BMI with QOL questionnaire variables measured with the functional assessment of cancer therapy (subscales: physical (PWB), functional (FWB), social, and emotional well-being) and the physical (PCS) and mental component summary subscales of the short-form medical outcomes survey was determined. Results. 152 women completed both questionnaires; 81% were obese. After multiple linear regression, BMI was inversely associated with PWB (P = .001), FWB (P = 0.048), and PCS (P = .001). Conclusions. Despite the good prognosis associated with early-stage EC, QOL, and physical health are not optimized in obese survivors. This paper highlights the importance of incorporating health-related QOL assessments and obesity interventions during the survivorship period.
  Obstetrics and Gynecology International 01/2011; 2011:308609.
• Article: A review of issues surrounding quality of life among women with ovarian cancer.

  Lucybeth Nieves Arriba, Amanda Nickles Fader, Heidi E Frasure, Vivian E von Gruenigen
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  ABSTRACT: Progress has been made towards prolonging survival of ovarian cancer patients. This trend has placed increasing attention upon the quality of life (QoL). The aim of this study was to review the existing literature on QoL, including measurement tools, and to explore opportunities to optimize well-being. A comprehensive computer literature search of English language studies was performed in MEDLINE databases up to February 2010. Validated tools have been used in multiple studies to provide a mechanism to asses information about QoL in ovarian cancer. Ovarian cancer and its treatment have significant effects on QoL including fatigue and the physical and functional domains. Studies indicate that ovarian cancer patients needs and QoL change during the trajectory of the disease. As new treatment strategies for ovarian cancer are developed, research efforts should identify how therapeutics will affect QoL and include interventions to prevent or minimize the detrimental effects.
  Gynecologic Oncology 11/2010; 119(2):390-6. · 3.89 Impact Factor
• Article: A comparison of quality-of-life domains and clinical factors in ovarian cancer patients: a Gynecologic Oncology Group study.

  Vivian E von Gruenigen, Helen Q Huang, Karen M Gil, Heidi E Gibbons, Bradley J Monk, Peter G Rose, Deborah K Armstrong, David Cella, Lari Wenzel
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  ABSTRACT: Women diagnosed with ovarian cancer are at risk for reduced quality of life (QOL). It is imperative to further define these declines to interpret treatment outcomes and design appropriate clinical interventions. The primary objective of this study was to compare data obtained from ovarian cancer patients with normative data to assess the degree to which QOL differs from the norm. Secondary objectives were to examine demographic variables and determine if there was a correlation between physical/functional and social/emotional scores during chemotherapy. Patients with Stage III/IV ovarian cancer on Gynecologic Oncology Group Protocols 152 and 172 who underwent surgery followed by intravenous paclitaxel and cisplatin completed the Functional Assessment of Cancer Therapy-Ovarian. The Functional Assessment of Cancer Therapy scale includes the four domains of physical, functional, social, and emotional well-being (PWB, FWB, SWB, and EWB, respectively). Ovarian cancer patients had a total QOL (Functional Assessment of Cancer Therapy-General) score similar to the U.S. female adult population. However, the reported subscale scores were 2.0 points (95% confidence interval [CI] 1.4-2.5, P<0.001, effect size=0.37) lower in PWB, 0.9 points (95% CI 0.3-1.5, P=0.005, effect size=0.13) lower in FWB, 5.0 points (95% CI 4.6-5.3, P<0.001, effect size=0.74) higher in SWB, and 0.8 points (95% CI 0.3-1.2, P<0.001, effect size=0.16) lower in EWB. Correlation between the sum of PWB and FWB and the sum of SWB and EWB was r=0.53 (P<0.001). Age was positively correlated with EWB (r=0.193; 95% CI 0.09-0.29). Ovarian cancer patients have decreased QOL in physical, functional, and emotional domains; however, they may compensate with increased social support. At the time of diagnosis and treatment, patients' QOL is affected by inherent characteristics. Assessment of treatment outcomes should take into account the effect of these independent variables.
  Journal of pain and symptom management 05/2010; 39(5):839-46. · 2.42 Impact Factor
• Article: Robotic gynecologic surgery.

  Vivian E von Gruenigen, William W Hurd
  Obstetrics and Gynecology 08/2009; 114(1):168; author reply 168-9. · 4.73 Impact Factor
• Article: Assessment of factors that contribute to decreased quality of life in Gynecologic Oncology Group ovarian cancer trials.

  Vivian E von Gruenigen, Helen Q Huang, Karen M Gil, Heidi E Gibbons, Bradley J Monk, Peter G Rose, Deborah K Armstrong, David Cella, Lari Wenzel
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  ABSTRACT: The objective of this study was to assess which quality-of-life (QOL) line items on the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) were associated with low QOL in women who were receiving chemotherapy for ovarian cancer. Patients with stage III or IV ovarian cancer on Gynecologic Oncology Group Protocols 152 and 172 who underwent primary surgery followed by intravenous paclitaxel and cisplatin completed the FACT-O. The FACT scale includes the 4 domains of physical, functional, social, and emotional well being (PWB, FWB, SWB, EWB, respectively). Women who had overall FACT-O scores in the lowest quartile (Q1) were compared with women in the upper 3 quartiles (Q2-Q4). The proportions of women in each group that selected the 2 worst categories for each item were compared. The level of significance was set at P<.005. Before Cycle 4, 361 patients (86.4%) provided valid QOL assessments. For PWB, a significantly greater proportion of women in Q1 versus Q2 through Q4 selected the 2 worst categories of several physical symptoms (nausea, pain, feeling ill, and being bothered by the side effects of treatment). For FWB, significant differences included being able to work, being content with the quality of their life, and sleeping well. For EWB, there were significant differences in feeling nervous and worrying about dying. There were virtually no differences between groups in SWB. Low interest in sex was reported by 56% to 88% of all patients (Q1-Q4). A large proportion of women with FACT-O scores in the lowest quartile reported problems that potentially were amenable to clinical interventions, such as symptom management and psychosocial support.
  Cancer 08/2009; 115(20):4857-64. · 4.77 Impact Factor
• Article: A phase I/II study of extended field radiation therapy with concomitant paclitaxel and cisplatin chemotherapy in patients with cervical carcinoma metastatic to the para-aortic lymph nodes: a Gynecologic Oncology Group study.

  Joan L Walker, Astrid Morrison, Paul DiSilvestro, Vivian E von Gruenigen
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  ABSTRACT: To determine the maximum tolerated dose (MTD) of weekly paclitaxel and cisplatin chemotherapy concurrent with extended field irradiation in women with cervical cancer metastatic to the para-aortic nodes. Patients with carcinoma of the cervix and histologically documented para-aortic node metastases were eligible for this phase I/II trial. Chemotherapy agents were administered weekly concurrent with extended field radiation with escalating doses of paclitaxel from 30-50 mg/m(2) in each of three cohorts of three patients each. A phase II cohort was then evaluated at the selected maximum tolerated dose (MTD). The MTD was determined to be cisplatin 40 mg/m(2) (maximum dose of 70 mg) and paclitaxel 40 mg/m(2) administered weekly for six cycles concurrent with extended field radiation therapy. There were 19 evaluable patients for the phase II analysis of toxicity and efficacy. Grade three and four gastrointestinal toxicity was seen in 6 and neutropenia in 7. Radiation therapy was successfully completed in 36.8% of patients at eight weeks and in 68.4% of patients at nine weeks, with a median time to completion was 56 days. A total of 27 evaluable patients were enrolled, twelve are dead (mean survival of those deceased is 25 months), and 15 (56%) are alive, and have been followed for a mean of 48 months (range 25-68; median of 46 months). Paclitaxel and cisplatin combination chemotherapy concurrent with extended field pelvic para-aortic irradiation can be administered at the described MTD and shows a higher than previously reported disease-free survival in relation to historical data. The 56% survival to date, and 50% estimated 48 month survival, warrants validation in a larger prospective cohort. Central radiation dose reduction is being considered in the next trial to decrease late toxicity of regimen.
  Gynecologic Oncology 12/2008; 112(1):78-84. · 3.89 Impact Factor
• Article: Feasibility and effectiveness of a lifestyle intervention program in obese endometrial cancer patients: a randomized trial.

  Vivian E von Gruenigen, Kerry S Courneya, Heidi E Gibbons, Mary Beth Kavanagh, Steven E Waggoner, Edith Lerner
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  ABSTRACT: The majority of endometrial cancer survivors (ECS) are obese and at risk for premature death. The purpose of this study was to assess feasibility of a lifestyle intervention program for promoting weight loss, change in eating behaviors, and increased physical activity in obese ECS. Early stage ECS (n=45) were randomized to a 6-month lifestyle intervention (LI; n=23) or usual care (UC; n=22). The LI group received group and individual counseling for 6 months. The primary endpoint was weight change. Secondary endpoints were physical activity, [Leisure score index (LSI)] and nutrient intake (3-day food records). Quantitative vitamin C and folate intake were used to assess fruit/vegetable intake. Recruitment was 29%, adherence (LI group) was 73% and 84% of participants completed follow-up assessments. At 12 months, the intervention group lost 3.5 kg compared to a 1.4 kg gain in the control group [mean difference=-4.9 kg; 95% CI: -9.0 to -0.9 kg; p=.018] and had an increased LSI score of 16.4 versus -1.3 in the control group from baseline [mean group difference=17.8; 95% CI=7.1 to 28.4; p=.002]. There were no differences in vitamin C and folate intake. The LI group had lower intake of kilocalories, although differences were not significant. A lifestyle intervention program in obese ECS is feasible and can result in sustained behavior change and weight loss over a 1-year period.
  Gynecologic Oncology 05/2008; 109(1):19-26. · 3.89 Impact Factor
• Article: Surgical treatments for vulvar and vaginal dysplasia: a randomized controlled trial.

  Vivian E von Gruenigen, Heidi E Gibbons, Karen Gibbins, Eric L Jenison, Michael P Hopkins
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  ABSTRACT: To compare pain, adverse effects and recurrence of dysplasia in patients with vaginal intraepithelial neoplasia or vulvar intraepithelial neoplasia prospectively treated by carbon dioxide laser or ultrasonic surgical aspiration. Patients were randomly assigned to receive treatment by laser or ultrasonic surgical aspiration from 2000-2005. Preoperative biopsy was done to confirm presence of dysplasia. Patients completed a visual analog scale regarding pain and were evaluated at 2-4 weeks to assess scarring, wound healing, and adverse effects. Patients returned every 3 months for 1 year for pelvic examination and cytology to assess recurrence. Follow-up colposcopy and biopsy were used at the discretion of the treating physician. Student t test, chi2, analysis of variance and multiple logistic regression were used for analysis. One hundred ten patients were randomly assigned. Ninety-six (87.3%) patients completed 1 year follow-up. Mean age of patients was 48.5 years. Mean visual analog scale score was significantly lower in patients treated by ultrasonic surgical aspiration (20.7 compared with 35.1; P=.032). For patients with vulvar lesions, there was less scarring with ultrasonic surgical aspiration (P<.01). Recurrence overall was 25% and was similar for ultrasonic surgical aspiration compared with laser (relative risk 0.96, 95% confidence interval 0.64-1.50, number needed to treat 95.6). Recurrence was associated with younger age (P<.01). Patients treated with ultrasonic surgical aspiration for vulvar and vaginal dysplasia reported less postoperative pain. Vulvar scarring was more common in patients treated by the laser. There was no difference in recurrence of dysplasia during a 1-year follow-up period between the two surgical modalities. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00394758 I.
  Obstetrics and Gynecology 04/2007; 109(4):942-7. · 4.73 Impact Factor
• Source

  Available from: PubMed Central

  Article: Baseline characteristics influencing quality of life in women undergoing gynecologic oncology surgery.

  Karen M Gil, Heidi E Gibbons, Eric L Jenison, Michael P Hopkins, Vivian E von Gruenigen
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  ABSTRACT: Quality of life (QoL) measurements are important in evaluating cancer treatment outcomes. Factors other than cancer and its treatment may have significant effects on QoL and affect assessment of treatments. Baseline data from longitudinal studies of women with endometrial or ovarian cancer or adnexal mass determined at surgery to be benign were analyzed to determine the degree to which QoL is affected by baseline differences in demographic variables and health. This study examined the effect of independent variables on domains of the Functional Assessment of Cancer Therapy (FACT-G) pre-operatively in gynecologic oncology patients undergoing surgery for pelvic mass suspected to be malignant or endometrial cancer. Patients also completed the Short Form Medical Outcomes Survey (SF-36) questionnaire (a generic health questionnaire that measures physical and mental health). Independent variables were surgical diagnosis (ovarian or endometrial cancer, benign mass), age, body mass index (BMI), educational level, marital status, smoking status, physical (PCS) and mental (MCS) summary scores of the SF-36. Multiple regression analysis was used to determine the influence of these variables on FACT-G domain scores (physical, functional, social and emotional well-being). Data were collected on 157 women at their pre-operative visit (33 ovarian cancer, 45 endometrial cancer, 79 determined at surgery to be benign). Mean scores on the FACT-G subscales and SF-36 summary scores did not differ as a function of surgical diagnosis. PCS, MCS, age, and educational level were positively correlated with physical well-being, while increasing BMI was negatively correlated. Functional well-being was positively correlated with PCS and MCS and negatively correlated with BMI. Social well-being was positively correlated with MCS and negatively correlated with BMI and educational level. PCS, MCS and age were positively correlated with emotional well-being. Models that included PCS and MCS accounted for 30 to 44% of the variability in baseline physical, emotional, and functional well-being on the FACT-G. At the time of diagnosis and treatment, patients' QoL is affected by inherent characteristics. Assessment of treatment outcome should take into account the effect of these independent variables. As treatment options become more complex, these variables are likely to be of increasing importance in evaluating treatment effects on QoL.
  Health and Quality of Life Outcomes 02/2007; 5:25. · 2.11 Impact Factor
• Article: Treatment effects, disease recurrence, and survival in obese women with early endometrial carcinoma : a Gynecologic Oncology Group study.

  Vivian E von Gruenigen, Chunqiao Tian, Heidi Frasure, Steven Waggoner, Henry Keys, Richard R Barakat
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  ABSTRACT: The objective was to examine whether rates of disease recurrence, treatment-related adverse effects, and survival differed between obese or morbidly obese and nonobese patients. Data from patients who participated in a randomized trial of surgery with or without adjuvant radiation therapy were retrospectively reviewed. RESULTS.: Body mass index (BMI) data were available for 380 patients, of whom 24% were overweight (BMI, 25-29.9), 41% were obese (BMI, 30-39.9), and 12% were morbidly obese (BMI, > or =40). BMI did not significantly differ based on age, performance status, histology, tumor grade, myometrial invasion, or lymphovascular-space involvement. BMI > 30 was more common in African Americans (73%) than non-African Americans (50%). Patients with a BMI > or = 40 compared with BMI < 30 (hazards ratio [HR], 0.42; 95% confidence interval [CI], 0.09-1.84; P = .246) did not have lower recurrence rates. Compared with BMI < 30, there was no significant difference in survival in patients with BMI 30-39.9 (HR, 1.48; 95% CI, 0.82-2.70; P = .196); however, there was evidence for decreased survival in patients with BMI > or = 40 (HR, 2.77; 95% CI, 1.21-6.36; P = .016). Unadjusted and adjusted BMI hazards ratios for African Americans versus non-African Americans in the current study differed, thus suggesting a confounding effect of BMI on race. Eight (67%) of 12 deaths among 45 morbidly obese patients were from noncancerous causes. For patients who received adjuvant radiation therapy, increased BMI was significantly associated with less gastrointestinal (R, -0.22; P = .003) and more cutaneous (R, 0.17; P = .019) toxicities. In the current study, obesity was associated with higher mortality from causes other than endometrial cancer but not disease recurrence. Increased BMI was also associated with more cutaneous and less gastrointestinal toxicity in patients who received adjuvant radiation therapy. Future recommendations include lifestyle intervention trials to improve survival in obese endometrial cancer patients.
  Cancer 01/2007; 107(12):2786-91. · 4.77 Impact Factor
• Article: Longitudinal assessment of quality of life and lifestyle in newly diagnosed ovarian cancer patients: the roles of surgery and chemotherapy.

  Vivian E von Gruenigen, Heidi E Frasure, Eric L Jenison, Michael P Hopkins, Karen M Gil
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  ABSTRACT: To prospectively evaluate quality of life (QoL), use of complementary and alternative medicine (CAM), and diet/exercise changes in ovarian cancer patients during the first 6 months following diagnosis. Patients with newly diagnosed ovarian cancer were enrolled pre- or post-operatively and surveyed at 3 and 6 months. The Functional Assessment of Cancer Therapy (FACT-G), Medical Outcomes Survey (SF-36), and CAM/diet/exercise questionnaires were used. Independent samples t test and repeated measures ANOVA were used. Forty-two patients underwent surgical debulking and staging prior to chemotherapy. Patients completing the initial surveys post-operatively had significantly lower physical FACT-G and SF-36 physical scores compared to patients completing the surveys pre-operatively. In patients completing the baseline survey pre-operatively, there was a decrease in physical scores at 3 months (after surgery and during chemotherapy). There was no change observed at 3 months relative to baseline when patients completed the baseline survey post-operatively. Increases in physical and functional well-being were seen at 6 months relative to 3 months. There were no changes in emotional or social scores over time. CAM use increased over time; main reasons were to improve QoL and relieve symptoms. Alterations in diet and exercise were not seen. These data highlight the need to conduct assessments before and after surgery to identify effects due to surgery and/or chemotherapy. Patients may be using CAM during chemotherapy to deal with symptoms and compensate for decreased QoL. Intervention trials should be implemented to increase QoL following surgery and during adjuvant chemotherapy.
  Gynecologic Oncology 11/2006; 103(1):120-6. · 3.89 Impact Factor
• Article: Body weight and composition changes in ovarian cancer patients during adjuvant chemotherapy.

  Karen M Gil, Heidi E Frasure, Michael P Hopkins, Eric L Jenison, Vivian E von Gruenigen
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  ABSTRACT: To prospectively examine body weight changes in women with newly diagnosed ovarian cancer receiving surgery and adjuvant chemotherapy. Body composition was examined in a subset of these women. Body weight (BW) and body composition, using bioelectrical impedance (RJL Systems Inc.), were prospectively measured pre- and post-operatively, and at 3, 6, and 12 months. Mean age of 42 women was 59 years and did not differ by stage of disease. Nine women with early stage disease did not receive adjuvant chemotherapy. Mean BW of 33 patients receiving chemotherapy decreased from the pre- to post-operative visit and then returned to baseline levels by 12 months (F = 8.70, P = 0.003). Nine patients who did not receive chemotherapy demonstrated a similar pattern (F = 7.0, P = 0.002). Women receiving chemotherapy with stage I/II cancer had a 2.8 +/- 2.0 kg weight gain over the year, and women with stage III/IV cancer had a 1.5 +/- 1.5 kg weight loss (t = 1.72, P = 0.096). A subset of women with stage I/II (n = 6) and stage III/IV (n = 6) ovarian cancer receiving chemotherapy had body composition measured at three time points. Absolute body fat changes paralleled changes in BW (F = 9.95, P = 0.002). Our study is the first prospective evaluation of body weight and composition in women undergoing surgery and chemotherapy for ovarian cancer. These results demonstrate that women undergoing surgery for ovarian cancer lost weight following surgery and regained it slowly over the following year. Further investigations of weight changes during adjuvant chemotherapy are indicated to assess potential changes in different stages of disease.
  Gynecologic Oncology 11/2006; 103(1):247-52. · 3.89 Impact Factor
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  Available from: PubMed Central

  Article: Gynecologic oncology patients' satisfaction and symptom severity during palliative chemotherapy.

  Vivian E von Gruenigen, Jessica R Hutchins, Anne Marie Reidy, Heidi E Gibbons, Barbara J Daly, Elisa M Eldermire, Nancy L Fusco
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  ABSTRACT: Research on quality and satisfaction with care during palliative chemotherapy in oncology patients has been limited. The objective was to assess the association between patient's satisfaction with care and symptom severity and to evaluate test-retest of a satisfaction survey in this study population. A prospective cohort of patients with recurrent gynecologic malignancies receiving chemotherapy were enrolled after a diagnosis of recurrent cancer. Patients completed the Quality of End-of-Life care and satisfaction with treatment scale (QUEST) once upon enrollment in an outpatient setting and again a week later. Patients also completed the Mini-Mental Status Exam, the Hospital Anxiety/Depression Scale, a symptom severity scale and a demographic survey. Student's t-test, correlation statistics and percent agreement were used for analysis. Data from 39 patients were analyzed. Mean (SD) quality of care summary score was 41.95 (2.75) for physicians and 42.23 (5.42) for nurses (maximum score was 45; p = 0.76 for difference in score between providers). Mean (SD) satisfaction of care summary score was 29.03 (1.92) for physicians and 29.28 (1.70) for nurses (maximum score was 30; p = 0.49 for difference between providers). Test-retest for 33 patients who completed both QUEST surveys had high percent agreement (74-100%), with the exception of the question regarding the provider arriving late (45 and 53%). There was no correlation between quality and satisfaction of care and symptom severity. Weakness was the most common symptom reported. Symptom severity correlated with depression (r = 0.577 p < 0.01). There was a trend towards a larger proportion of patients reporting pain who had three or more prior chemotherapy regimens (p = 0.075). Prior number of chemotherapy regimens or time since diagnosis was not correlated with symptom severity score. Anxiety and depression were correlated with each other (r = 0.711, p < 0.01). There was no difference in symptom severity score at enrollment between those patients who have since died (n = 19) versus those who are still alive. The QUEST Survey has test-retest reliability when used as a written instrument in an outpatient setting. However, there was no correlation between this measure and symptom severity. Patient evaluation of care may be more closely related to the interpersonal aspects of the health care provider relationship than it is to physical symptoms.
  Health and Quality of Life Outcomes 01/2006; 4:84. · 2.11 Impact Factor