[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 · 15.16 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 · 1.83 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To investigate the diagnostic accuracy of ultrasound histogram features in the quantitative assessment of radiation-induced parotid gland injury and to identify potential imaging biomarkers for radiation-induced xerostomia (dry mouth)-the most common and debilitating side effect after head-and-neck radiotherapy (RT).
[Show abstract][Hide abstract] ABSTRACT: There is no consensus as to what symptoms or quality-of-life (QOL) domains should be measured as patient-reported outcomes (PROs) in ovarian cancer clinical trials. A panel of experts convened by the National Cancer Institute reviewed studies published between January 2000 and August 2011. The results were included in and combined with an expert consensus-building process to identify the most salient PROs for ovarian cancer clinical trials. We identified a set of PROs specific to ovarian cancer: abdominal pain, bloating, cramping, fear of recurrence/disease progression, indigestion, sexual dysfunction, vomiting, weight gain, and weight loss. Additional PROs identified in parallel with a group charged with identifying the most important PROs across cancer types were anorexia, cognitive problems, constipation, diarrhea, dyspnea, fatigue, nausea, neuropathy, pain, and insomnia. Physical and emotional domains were considered to be the most salient domains of QOL. Findings of the review and consensus process provide good support for use of these ovarian cancer-specific PROs in ovarian cancer clinical trials.
JNCI Journal of the National Cancer Institute 07/2014; 106(7). DOI:10.1093/jnci/dju128 · 15.16 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: We identified a standard core set of patient-reported symptoms and health-related quality-of-life (HRQOL) domains to be assessed in head and neck (H&N) cancer clinical trials. The core symptom and HRQOL domain scores were used to guide recommendations by a working group of experts as part of a National Cancer Institute Symptom Management and HRQOL Clinical Trials Planning Meeting. A PubMed search was conducted using the search terms of "health-related quality of life" and "head & neck cancer," limited to publications from January 1, 2000, to December 31, 2010. Fifty-four articles were used to guide the choice of recommendations. Twenty-nine symptoms and nine domains were identified, from which 12 H&N-specific core symptoms and HRQOL domains were recommended: swallowing, oral pain, skin changes, dry mouth, dental health, opening mouth/trismus, taste, excess/thick mucous/saliva, shoulder disability/motion, voice/hoarseness, social domain, and functional domain. This core set of 12 H&N-specific, patient-reported symptoms and HRQOL domains should be assessed in future H&N cancer clinical trials.
JNCI Journal of the National Cancer Institute 07/2014; 106(7). DOI:10.1093/jnci/dju127 · 15.16 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The National Cancer Institute's Symptom Management and Health-Related Quality of Life Steering Committee held a clinical trials planning meeting (September 2011) to identify a core symptom set to be assessed across oncology trials for the purposes of better understanding treatment efficacy and toxicity and to facilitate cross-study comparisons. We report the results of an evidence-synthesis and consensus-building effort that culminated in recommendations for core symptoms to be measured in adult cancer clinical trials that include a patient-reported outcome (PRO).
JNCI Journal of the National Cancer Institute 07/2014; 106(7). DOI:10.1093/jnci/dju129 · 15.16 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Purpose: Xerostomia (dry mouth), secondary to parotid-gland injury, is a distressing side-effect in head-and-neck radiotherapy (RT). This study's purpose is to develop a novel ultrasound technique to quantitatively evaluate post-RT parotid-gland injury.
Medical Physics 06/2014; 41(6):571-571. DOI:10.1118/1.4889673 · 3.01 Impact Factor