Patient and physician factors associated with participation in cervical and uterine cancer trials: an NRG/GOG247 study.
OBJECTIVE
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.
Norton Healthcare Louisville, KY 40202, United States. Electronic address: sandraebrooks40@aol.com.
Sandra E
SE
Brooks
University at Buffalo, NY, United States; NRG Oncology Statistics and Data Management Center, United States; Roswell Park Cancer Institute, Buffalo, NY 14263, United States.
Randy L
RL
Carter
Gynecologic Oncology, Rebecca and John Moores UCSD Cancer Center, La Jolla, CA 92093, United States.
Steven C
SC
Plaxe
Department of Behavioral Science, University of Texas, MD Anderson Cancer Center, Houston, TX 77030, United States.
Karen M
KM
Basen-Engquist
Gynecologic Oncology, Northern Indiana Cancer Research Consortium, Memorial Hospital, Mishawaka, IN 46545, United States.
Michael
M
Rodriguez
University at Buffalo, NY, United States; NRG Oncology Statistics and Data Management Center, United States; Roswell Park Cancer Institute, Buffalo, NY 14263, United States.
James
J
Kauderer
Gynecologic Oncology, University of Oklahoma, Oklahoma City, OK 73104, United States.
Joan L
JL
Walker
GYN/ONC, Baystate Medical Center, Springfield, MA 01199, United States.
Tashanna K N
TK
Myers
Gynecologic Oncology, Waukesha Memorial Hospital, Waukesha, WI 01199, United States.
Janet G
JG
Drake
OB/GYN, Duke University Medical Center, Durham, NC 27710, United States.
Laura J
LJ
Havrilesky
Gynecologic Oncology, University of Norton Carolina, Chapel Hill, NC 26588, United States.
Linda
L
Van Le
Gynecologic Oncology, University of Oklahoma, Oklahoma City, OK 73104, United States.
Lisa M
LM
Landrum
Office of Diversity Programs in Clinical Care, Research and Training, Memorial Sloan-Kettering Cancer Center, New York, NY 10065, United States.
Carol L
CL
Brown
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002986:Clinical Trials as Topic / Q000379:methods* / Q000523:psychology*; D003657:Decision Making; D005260:Female; D006801:Humans; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D018579:Patient Selection; D010820:Physicians / Q000523:psychology*; D011446:Prospective Studies; D002583:Uterine Cervical Neoplasms / Q000523:psychology* / Q000628:therapy; D014594:Uterine Neoplasms / Q000523:psychology* / Q000628:therapy; D055815:Young Adult
Cervical cancer trials; Clinical trial enrollment; Gynecologic Oncology Group; Minority enrollment; NRG Oncology; Patient and physician factors; Uterine cancer trials