Impact of a regular exercise program on amount of exercise and QOL metrics in patients on immune therapy.

Abstract

TPS11636 Background: Studies show physical activity has a positive impact on fatigue and quality of life both during cancer treatment with chemotherapy and radiation and post-treatment (1, 2). There may also be a survival benefit to increasing physical activity both during and after treatment (3). To date there is no published research on the role of exercise in ameliorating the fatigue patients can experience during treatment with immune therapy. Our study proposes to use the existing framework of the LIVESTRONG at the YMCA program to objectively measure improvement in activity level and objective quality of life measurements. Methods: Randomized controlled prospective study evaluating patient participation in LIVESTRONG at YMCA program during active cancer treatment to assess change in minutes per week of self-reported physical activity over 12 weeks. Assessments will be done based on attendance of 12 week program, activity log, functional assessments of physical activity pre- and post- program (6 min walk test, % change in weight, % change in max weight lifted and flexibility), and questionnaires evaluating fatigue (PROMIS 13a FACIT-F), pain (PROMIS pain intensity scale, ASCQ-Me short form), quality of life (FACT-G), Godin Leisure Time Activity Questionnaire, and inflammatory markers (ESR, CRP). Data will be analyzed on an intention-to-treat analysis. A sample size of 100 participants per group will achieve 80% power to detect a 60 minute difference with a standard deviation of 150 minutes 1 and with a significance level (alpha) of 0.050 using a two-sided two-sample t-test. Enrollment is targeted at 108 participants per arm to allow for 8% attrition, 216 total. Secondary endpoints will be assessed at a baseline functional assessment session for all participants and a follow up session after 12 weeks, including administration of questionnaires at both sessions. For physical activity measurements and survey completions, percent change in baseline and completion measurements will be calculated for each patient, then comparison using a chi-square test will be done to determine statistical significance.(Tomlinson et al. Effect of exercise on cancer-related fatigue: a meta-analysis. Am J Phys Med Rehabil. 2014;93:675-686; Irwin et al. Effect of the LIVESTRONG at the YMCA Exercise Program on Physical Activity, Fitness, Quality of Life, and Fatigue in Cancer Survivors. 2016 (published online October 28, 2016); Li T et al. The dose–response effect of physical activity on cancer mortality: findings from 71 prospective cohort studies . Br J Sports Med. 2016;50:339-345).