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

Abstract

Purpose 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.

Clinical trial participation and aggressive care at the end of life in patients with ovarian cancer

“…As this population has been shown to have low rates of palliative care consultation,29 the lack of difference in end of life outcomes may be related to high rates of end of life intervention in both groups. The homogeneity of the population makes it difficult to comment on the association of race with trial participation, although this has been shown to be significant in other studies 4 30. We were not able to draw a conclusion as to why participation in clinical trials is associated with a survival advantage, but can only speculate that it may be related to selection bias and perhaps a true therapeutic advantage of clinical trials.…”

“…The American Society of Clinical Oncology (ASCO) maintains that “clinical trials are essential for evaluating new treatment modalities, establishing new standards of cancer care and, ultimately, improving and prolonging the lives of patients with cancer” 1. However, fewer than 5% of all adults with cancer enroll in clinical trials in the USA,2 3 and 80% of clinical trials struggle to meet projected accrual targets 4. Although participation in clinical trials has been associated with improved survival in multiple disease sites,2 5 6 including ovarian cancer,7 8 there was an 82% reduction in accrual for gynecologic oncology trials between the years 2011 and 2016 9…”

“When Offered to Participate”: A Systematic Review and Meta-Analysis of Patient Agreement to Participate in Cancer Clinical Trials

“…Thirty-five studies comprised of 9759 patients met our inclusion criteria ( Figure 2 ) ( 8 , 9 , 30–62 ). Most studies (n = 30, 85.7%) focused on treatment for cancer ( Table 1 ) ( 8 , 9 , 30–32 , 34 , 35 , 37 , 39 , 40 , 42–55 , 57–62 ). Among the 5 cancer control studies, 4 focused on enrollment to cancer survivorship studies and 1 to a symptom management study ( Table 2 ) ( 33 , 36 , 38 , 41 , 56 ).…”

Is age a prognostic biomarker for survival among women with locally advanced cervical cancer treated with chemoradiation? An NRG Oncology/Gynecologic Oncology Group ancillary data analysis

“…This doesn’t mean these patients were ineligible, they were just being seen at a place where a trial wasn’t available. GOG-247 did note that multiple co-morbid illnesses were negatively associated with eligibility for a clinical trial (p = 00019) but this was not reported for age [24]. …”