SWOG S1820: Altering Intake, Managing Symptoms for bowel dysfunction in survivors of Rectal Cancer (The AIMS-RC intervention trial)

Objective: To describe the study protocol of SWOG S1820, a trial of the Altering Intake, Managing Symptoms intervention for bowel dysfunction in survivors of Rectal Cancer (AIMS-RC). Design: SWOG S1820 is a multi-site, randomized trial of 94 post-treatment survivors of rectal cancer, comparing the intervention and attention control arms. Setting: Affiliated institutions of the National Cancer Institute (NCI)-supported National Community Oncology Research Program (NCORP) and the National Clinical Trial Network (NCTN). Participants: Survivors of rectal cancer who are between 6 and 24 months after treatment completion. Intervention: AIMS-RC is a 17-week, 10 session telephone coaching program to help survivors of rectal cancer track their symptoms and improve their diets for better health and bowel function. It includes telephone-based coaching, resource manual, and personalized text/email messaging for motivation in between the telephone sessions. Main outcome measures: Bowel function, low anterior resection syndrome score, quality of life (QOL), dietary quality, motivation, self-efficacy, positive/negative affect, feasibility, adherence, retention, acceptability. Analysis: Thirty-seven participants per arm (74 total) provide 80% power to detect this 0.5 standard deviation effect size, based on a two-sample t-test with a 1-sided alpha = 0.1. A total of 94 randomized participants will be accrued to account for 7% ineligibility and 15% attrition at 6 months. © 2021 The AuthorsOpen access journalThis item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at repository@u.library.arizona.edu