Barriers to clinical trial enrollment of older adults with cancer: A systematic review.

Abstract

e18130 Background: Despite the disproportionate impact of cancer on older adults, older patients are vastly underrepresented in clinical trials that set the standards for cancer treatment. To better understand the reasons for this disparity, we conducted a systematic review of studies that have specifically examined barriers and interventions to improve clinical trial enrollment of older adults with cancer. Methods: We conducted a comprehensive two-step search strategy. First, we consulted an information specialist to develop an electronic search for the following databases from inception to January 15, 2019: PubMed, Ovid/Medline, Embase, Scopus, PsycINFO, and Cochrane library. Second, references of retrieved key articles were screened for relevant studies. Two authors then independently reviewed all titles and abstracts (N = 10,985) and examined studies for full text eligibility (N = 221). Inclusion criteria were: 1) original research; 2) study assessed barriers and/or interventions to enrollment in oncology clinical trials; 3) included patients ≥ 60 years with cancer. Narrative reviews and abstracts without full text were excluded. Data was extracted by independent raters and summarized using a qualitative analysis software, NVivo v12. Results: 12 observational studies examining barriers and 1 randomized intervention were included. Barriers were assessed at the patient level (N = 5 studies), healthcare professional (HCP) level (N = 5), and both patient and HCP levels (N = 2). Stringent eligibility criteria (N = 7) and oncologists’ concerns for toxicity (N = 7) were the most common barriers cited. Patient barriers included transportation (N = 6), time/burden (N = 6), and awareness (N = 6). Although caregiver barriers (N = 4) were identified, none of the studies examined caregiver perceptions. One study evaluated a physician-directed educational intervention and found no significant impact on accrual of older adults. Conclusions: Although several studies have examined the barriers to accrual of older adults with cancer, only one intervention study has attempted to address these barriers. Given the aging of the cancer population, new strategies for including older adults in cancer clinical trials are critically needed.