Patient and physician factors associated with participation in cervical and uterine cancer trials: An NRG/GOG247 study
Year: 2015
Type: article
Study design: Observational Study
Abstract: PURPOSE: The aim of this study was to identify patient and physician factors related to enrollment onto Gynecologic Oncology Group (GOG) trials. METHODS: Prospective study of women with primary or recurrent cancer of the uterus or cervix treated at a GOG institution from July 2010 to January 2012. Logistic regression examined probability of availability, eligibility and enrollment in a GOG trial. Odds ratios (OR) and 95% confidence intervals (CI) for significant (p<0.05) results reported. RESULTS: Sixty institutions, 781 patients, and 150 physicians participated, 300/780 (38%) had a trial available, 290/300 had known participation status. Of these, 150 women enrolled (59.5%), 102 eligible did not enroll (35%), 38 (13%) were ineligible. Ethnicity and specialty of physician, practice type, data management availability, and patient age were significantly associated with trial availability. Patients with >4 comorbidities (OR 4.5; CI 1.7-11.8) had higher odds of trial ineligibility. Non-White patients (OR 7.9; CI 1.3-46.2) and patients of Black physicians had greater odds of enrolling (OR 56.5; CI 1.1-999.9) in a therapeutic trial. Significant patient therapeutic trial enrollment factors: belief trial may help (OR 76.9; CI 4.9->1000), concern about care if not on trial (OR12.1; CI 2.1-71.4), pressure to enroll (OR .27; CI 0.12-.64), caregiving without pay (OR 0.13; CI .02-.84). Significant physician beliefs were: patients would not do well on standard therapy (OR 3.6; CI 1.6-8.4), and trial would not be time consuming (OR 3.3; CI 1.3-8.1). CONCLUSIONS: Trial availability, patient and physician beliefs were factors identified that if modified could improve enrollment in cancer cooperative group clinical trials.
Source: Gynecologic Oncology
Institutions: Norton Healthcare, Norton Hospital, Roswell Park Comprehensive Cancer Center, NRG Oncology, University at Buffalo, State University of New York, University of California San Diego, Moores Cancer Center, The University of Texas MD Anderson Cancer Center, Northern Indiana Cancer Research Consortium, University of Oklahoma, Baystate Medical Center, Waukesha Memorial Hospital, Duke Medical Center, University of North Carolina at Chapel Hill, Memorial Sloan Kettering Cancer Center
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,380
OpenAlex ID: W2121930393
