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. 2021 Apr 8:22:100768.
doi: 10.1016/j.conctc.2021.100768. eCollection 2021 Jun.

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

Virginia Sun  1   2 , Tracy E Crane  3   4 , Kathryn B Arnold  5 , Katherine Guthrie  5 , Sarah Freylersythe  4 , Christa Braun-Inglis  6 , Lee Jones  7 , Stacey A Cohen  8   9 , Mazin Al-Kasspooles  10 , Robert S Krouse  11 , Cynthia A Thomson  4   12
Affiliations

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

Virginia Sun et al. Contemp Clin Trials Commun. .

Abstract

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.

Keywords: Bowel dysfunction; Diet; QOL; Rectal cancer; Survivorship.

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Fig. 1
Study schema.
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