Format

Send to

Choose Destination
Gynecol Oncol. 2015 Jul;138(1):101-8. doi: 10.1016/j.ygyno.2015.04.033. Epub 2015 Apr 30.

Patient and physician factors associated with participation in cervical and uterine cancer trials: an NRG/GOG247 study.

Author information

1
Norton Healthcare Louisville, KY 40202, United States. Electronic address: sandraebrooks40@aol.com.
2
University at Buffalo, NY, United States; NRG Oncology Statistics and Data Management Center, United States; Roswell Park Cancer Institute, Buffalo, NY 14263, United States.
3
Gynecologic Oncology, Rebecca and John Moores UCSD Cancer Center, La Jolla, CA 92093, United States.
4
Department of Behavioral Science, University of Texas, MD Anderson Cancer Center, Houston, TX 77030, United States.
5
Gynecologic Oncology, Northern Indiana Cancer Research Consortium, Memorial Hospital, Mishawaka, IN 46545, United States.
6
Gynecologic Oncology, University of Oklahoma, Oklahoma City, OK 73104, United States.
7
GYN/ONC, Baystate Medical Center, Springfield, MA 01199, United States.
8
Gynecologic Oncology, Waukesha Memorial Hospital, Waukesha, WI 01199, United States.
9
OB/GYN, Duke University Medical Center, Durham, NC 27710, United States.
10
Gynecologic Oncology, University of Norton Carolina, Chapel Hill, NC 26588, United States.
11
Office of Diversity Programs in Clinical Care, Research and Training, Memorial Sloan-Kettering Cancer Center, New York, NY 10065, United States.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01098630.

KEYWORDS:

Cervical cancer trials; Clinical trial enrollment; Gynecologic Oncology Group; Minority enrollment; NRG Oncology; Patient and physician factors; Uterine cancer trials

PMID:
25937529
PMCID:
PMC4489417
DOI:
10.1016/j.ygyno.2015.04.033
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Elsevier Science Icon for PubMed Central
Loading ...
Support Center