Representation in clinical trials evaluating lifestyle interventions targeting energy balance in cancer survivors: A scoping review.

Abstract

e23017 Background: The rate of clinical trial participation in any cancer research study is 22%, with 7% in cancer treatments (drug, devices, behavior). However, clinical trial enrollment data specific to lifestyle interventions in the cancer population are limited. Identifying gaps in enrollment and enhancing generalizability of lifestyle interventions for cancer survivors is imperative to improve survival, quality of life and reduce cancer recurrence risk in diverse populations. To address some of these gaps, we conducted a scoping review using PRISMA guidelines to determine the representation of cancer survivors by sex, race, ethnicity, age, and cancer type in clinical trials evaluating lifestyle interventions. Methods: Studies were considered eligible if the following criteria were met: 1) Sample of adults 18 years with a cancer diagnosis; and 2) report on an intervention designed to change one or more lifestyle behavior (diet, physical activity, weight control). Observational studies, qualitative studies, and protocol papers were excluded. Studies including children, pharmacologic, or surgical interventions were also excluded. Medical subject headings (MESH) and terms related to cancer survivorship and lifestyle intervention were used for the literature search. Studies were imported into Rayyan for title/abstract review. Two reviewers independently reviewed the full text of articles for inclusion. Data were then extracted and entered into REDCap. Means and proportions were calculated for respective quantitative and categorical variables. Results: A total of 117 articles were included. Approximately 11% of articles targeted diet, 70% targeted physical activity, and 19% targeted both diet and physical activity. On average, the mean age of the samples was 56.4 years (SD = 8.4), with a range of 33-75 years, and were majority female (80%). Just over half (52%) of the articles provided information on race and ethnicity. Of these, the samples reported mostly White (79%), Black or African American (20%), and Hispanic/Latino (13%). The most common cancer types represented were breast (72%), colorectal (22%), prostate (15%), endometrial (12%), ovarian (10%), and lung cancer (10%). Conclusions: Most of the lifestyle intervention trials focused on breast cancer survivors (51%). Despite rising rates of cancer in women under 50, limited lifestyle intervention trials included young adult cancer survivors. Similarly, though prostate cancer is the leading cancer in men, trial enrollment is low. Hispanic/Latino populations have the highest prevalence of modifiable cancer risk factors, yet trial enrollment was also low. These findings suggest that targeted efforts are needed to develop lifestyle interventions that can bolster enrollment in subgroups of the cancer survivor population including young women, men with prostate cancer, and Hispanic/Latino population.