[Show abstract][Hide abstract] ABSTRACT: Patients with head and neck cancer (HNC) receiving intensity-modulated radiation therapy (IMRT) have particularly high rates of fatigue, and pre- and post-radiotherapy fatigue are prognostic factors for pathologic tumor responses and poor survival. Although inflammation has been proposed as one of the potential mechanisms of fatigue in cancer patients, findings have not been consistent, and there is a dearth of longitudinal studies. Accordingly, we conducted a prospective study in 46 HNC patients pre- and one-month post-IMRT. Fatigue was measured by the Multidimensional Fatigue Inventory (MFI)-20 at both time points along with the assessment of peripheral blood inflammatory markers including interleukin (IL)-6, soluble tumor necrosis factor receptor 2, and C-reactive protein (CRP) and gene expression. Generalized estimating equations were used to examine the association between inflammatory markers and fatigue. Gene enrichment analysis using MetaCore Software was performed using up-regulated genes that were significantly associated with IMRT and fatigue. Significant associations between fatigue and IL-6 as well as CRP, which were independent of time, were observed. In addition the change in fatigue from pre- to post-IMRT was positively associated with the change in IL-6 and CRP. Analysis of up-regulated gene transcripts as a function of IMRT and fatigue revealed overrepresentation of transcripts related to the defense response and nuclear factor kappa B. In conclusion, our findings support the hypotheses that inflammation is associated with fatigue over time in HNC patients. Future studies on how inflammation contributes to fatigue as well as strategies targeting inflammation to reduce fatigue are warranted.
Brain Behavior and Immunity 10/2015; DOI:10.1016/j.bbi.2015.10.016 · 5.89 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: IntroductionThe Patient-Reported Outcomes Measurement Information System (PROMIS)® Sexual Function and Satisfaction measure (SexFS) version 1.0 was developed with cancer populations. There is a need to expand the SexFS and provide evidence of its validity in diverse populations.AimThe aim of this study was to describe the development of the SexFS v2.0 and present preliminary evidence for its validity.Methods
Development built on version 1.0, plus additional review of extant items, discussions with 15 clinical experts, 11 patient focus groups (including individuals with diabetes, heart disease, anxiety, depression, and/or are lesbian, gay, bisexual, or aged 65 or older), 48 cognitive interviews, and psychometric evaluation in a random sample of U.S. adults plus an oversample for specific sexual problems (2281 men, 1686 women). We examined differential item functioning (DIF) by gender and sexual activity. We examined convergent and known-groups validity.ResultsThe final set of domains includes 11 scored scales (interest in sexual activity, lubrication, vaginal discomfort, clitoral discomfort, labial discomfort, erectile function, orgasm ability, orgasm pleasure, oral dryness, oral discomfort, satisfaction), and six nonscored item pools (screeners, sexual activities, anal discomfort, therapeutic aids, factors interfering with sexual satisfaction, bother). Domains from version 1.0 were reevaluated and improved. Domains considered applicable across gender and sexual activity status, namely interest, orgasm, and satisfaction, were found to have significant DIF. We identified subsets of items in each domain that provided consistent measurement across these important respondent groups. Convergent and known-groups validity was supported.Conclusions
The SexFS version 2.0 has several improvements and enhancements over version 1.0 and other extant measures, including expanded evidence for validity, scores centered around norms for sexually active U.S. adults, new domains, and a final set of items applicable for both men and women and those sexually active with a partner and without. The SexFS is customizable, allowing users to select relevant domains and items for their study. Weinfurt KP, Lin L, Bruner DW, Cyranowski JM, Dombeck CB, Hahn EA, Jeffery DD, Luecht RM, Magasi S, Porter LS, Reese JB, Reeve BB, Shelby RA, Smith AW, Willse JT, and Flynn KE. Development and Initial Validation of the PROMIS® Sexual Function and Satisfaction Measures Version 2.0. J Sex Med **;**:**–**.
Journal of Sexual Medicine 09/2015; 12(9). DOI:10.1111/jsm.12966 · 3.15 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To integrate the patient perspective into adverse event reporting, the National Cancer Institute developed a patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
To assess the construct validity, test-retest reliability, and responsiveness of PRO-CTCAE items.
A total of 975 adults with cancer undergoing outpatient chemotherapy and/or radiation therapy enrolled in this questionnaire-based study between January 2011 and February 2012. Eligible participants could read English and had no clinically significant cognitive impairment. They completed PRO-CTCAE items on tablet computers in clinic waiting rooms at 9 US cancer centers and community oncology practices at 2 visits 1 to 6 weeks apart. A subset completed PRO-CTCAE items during an additional visit 1 business day after the first visit.
Primary comparators were clinician-reported Eastern Cooperative Oncology Group Performance Status (ECOG PS) and the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30).
A total of 940 of 975 (96.4%) and 852 of 940 (90.6%) participants completed PRO-CTCAE items at visits 1 and 2, respectively. At least 1 symptom was reported by 938 of 940 (99.8%) participants. Participants' median age was 59 years; 57.3% were female, 32.4% had a high school education or less, and 17.1% had an ECOG PS of 2 to 4. All PRO-CTCAE items had at least 1 correlation in the expected direction with a QLQ-C30 scale (111 of 124, P < .05 for all). Stronger correlations were seen between PRO-CTCAE items and conceptually related QLQ-C30 domains. Scores for 94 of 124 PRO-CTCAE items were higher in the ECOG PS 2 to 4 vs 0 to 1 group (58 of 124, P < .05 for all). Overall, 119 of 124 items met at least 1 construct validity criterion. Test-retest reliability was 0.7 or greater for 36 of 49 prespecified items (median [range] intraclass correlation coefficient, 0.76 [0.53-.96]). Correlations between PRO-CTCAE item changes and corresponding QLQ-C30 scale changes were statistically significant for 27 prespecified items (median [range] r = 0.43 [0.10-.56]; all P ≤ .006).
Evidence demonstrates favorable validity, reliability, and responsiveness of PRO-CTCAE in a large, heterogeneous US sample of patients undergoing cancer treatment. Studies evaluating other measurement properties of PRO-CTCAE are under way to inform further development of PRO-CTCAE and its inclusion in cancer trials.
[Show abstract][Hide abstract] ABSTRACT: Purpose/Objective(s): Vaginal stenosis (VS) is a recognized complication
of pelvic and/or vaginal radiation therapy (RT). However, there is no
consensus on its definition, diagnosis, prevention and treatment. As such,
an internet-based survey was designed to assess radiation oncologists’
perceptions and practices concerning VS.
Materials/Methods: After obtaining IRB exemption, a 24-item survey
assessing the signs/symptoms, risk factors, diagnosis, prevention, treatment
and impact of VS on women’s sexual health was distributed to 2200
Radiation Therapy Oncology Group (RTOG) members. Descriptivestatistics were calculated for all items. Chi-square tests examined differences
in categorical responses by gender, experience level, practice setting
and types of malignancies treated.
Results: 233 (10.5%) completed the entire survey (99% radiation oncologists;
63% males; 52% academic [vs community], 46% >15 years [vs
�15] in practice). Twelve%, 21%, and 68% report treating only GYN
tumors (endometrial and cervical), only non-GYN female (rectal, anal,
bladder), or both, respectively. Regarding risk factors, 78% attribute VS to
pelvic RT alone, 91% to vaginal brachytherapy (VB) alone and 98% to
combined pelvic RT and VB. Women without a cervix and post-menopausal
status were considered at higher risk. VS risk was felt to be equal
for obese vs non-obese and <70 vs �70 years of age. All respondents
agree that VS is a clinical diagnosis, and no objective test is available.
Reported VS symptoms include dyspareunia, and vaginal pain, dryness,
and/or bleeding (100%, 90%, 85% and 72%, respectively); 65% indicate
all four are reported. Vaginal dilator (VD) use is the only reported treatment
of VS; 95% provide VDs to patients, and most commonly recommend
initiating <6 weeks after RT completion (59%), 3 sessions per week
(62%), for 2-10 minutes per session (64%), and for >1 year (70%). No
difference in any response is found when examined by gender, experience
level or practice setting. However, those who treat only GYN vs no GYN
cancers are more likely to perform a vaginal exam before, during, or after
RT (p Z 0.005, <0.001, 0.003, respectively), to distribute written in
addition to verbal instructions regarding VD use (p Z 0.002), to have
vaginal bleeding reported after RT (p Z 0.001), and to refer patients to a
sexual councilor (p Z 0007).
Conclusion: This is the first large-scale survey of radiation oncologists’
perceptions and practices regarding vaginal stenosis. While VS is a
recognized complication of treating pelvic malignancies, and the majority
of respondents use vaginal dilators, there is no consensus on its risk factors,
diagnosis, treatment and prevention. Prospective research, including
symptom-management clinical trials, is therefore warranted.
American Society for Radiation Oncology 56th Annual Meeting, San Francisco, CA; 11/2014
[Show abstract][Hide abstract] ABSTRACT: The standard approach for documenting symptomatic adverse events (AEs) in cancer clinical trials involves investigator reporting
using the National Cancer Institute’s (NCI’s) Common Terminology Criteria for Adverse Events (CTCAE). Because this approach
underdetects symptomatic AEs, the NCI issued two contracts to create a patient-reported outcome (PRO) measurement system as
a companion to the CTCAE, called the PRO-CTCAE. This Commentary describes development of the PRO-CTCAE by a group of multidisciplinary
investigators and patient representatives and provides an overview of qualitative and quantitative studies of its measurement
properties. A systematic evaluation of all 790 AEs listed in the CTCAE identified 78 appropriate for patient self-reporting.
For each of these, a PRO-CTCAE plain language term in English and one to three items characterizing the frequency, severity,
and/or activity interference of the AE were created, rendering a library of 124 PRO-CTCAE items. These items were refined
in a cognitive interviewing study among patients on active cancer treatment with diverse educational, racial, and geographic
backgrounds. Favorable measurement properties of the items, including construct validity, reliability, responsiveness, and
between-mode equivalence, were determined prospectively in a demographically diverse population of patients receiving treatments
for many different tumor types. A software platform was built to administer PRO-CTCAE items to clinical trial participants
via the internet or telephone interactive voice response and was refined through usability testing. Work is ongoing to translate
the PRO-CTCAE into multiple languages and to determine the optimal approach for integrating the PRO-CTCAE into clinical trial
workflow and AE analyses. It is envisioned that the PRO-CTCAE will enhance the precision and patient-centeredness of adverse
event reporting in cancer clinical research.
JNCI Journal of the National Cancer Institute 09/2014; 106(9):dju244-dju244. DOI:10.1093/jnci/dju244 · 12.58 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The goal of the Patient-Reported Outcomes Measurement Information System (PROMIS) is to create efficient, reliable, and valid assessments of adult and child health. The nursing science literature in which PROMIS measures are used is rapidly expanding. Investigators have been encouraged to consider the integration of PROMIS measures into both descriptive studies and clinical trials. Doing this has created opportunities and challenges for investigators. This article highlights three projects to show the perspectives of nurse scientists who incorporated PROMIS measures into their research. The first project describes advantages of PROMIS to allow for comparisons of a study population with a national sample and to compliment legacy measures. The second project examines issues in the translation of tools for region-specific Hispanic populations. The third project provides a perspective on the use of PROMIS measures to capture cancer-related fatigue and to develop new components of a sexual function scale. As indicated by these three examples, nurse scientists can contribute an important role in moving the PROMIS initiative forward. Results from these types of projects also move symptom science forward within a more interdisciplinary approach to common measures of interest.
Nursing Outlook 09/2014; 62(5):332-338. DOI:10.1016/j.outlook.2014.06.009 · 1.59 Impact Factor