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

Virginia Sun; Tracy E Crane; Kathryn B Arnold; Katherine Guthrie; Sarah Freylersythe; Christa Braun-Inglis; Lee Jones; Stacey A Cohen; Mazin Al-Kasspooles; Robert S Krouse; Cynthia A Thomson

doi:10.1016/j.conctc.2021.100768

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

Contemp Clin Trials Commun. 2021 Apr 8:22:100768. doi: 10.1016/j.conctc.2021.100768. eCollection 2021 Jun.

Authors

Virginia Sun^{1

2}, Tracy E Crane^{3

4}, Kathryn B Arnold⁵, Katherine Guthrie⁵, Sarah Freylersythe⁴, Christa Braun-Inglis⁶, Lee Jones⁷, Stacey A Cohen^{8

9}, Mazin Al-Kasspooles¹⁰, Robert S Krouse¹¹, Cynthia A Thomson^{4

12}

Affiliations

¹ Department of Population Sciences, City of Hope, Duarte, CA, USA.
² Department of Surgery, City of Hope, Duarte, CA, USA.
³ College of Nursing, University of Arizona, Tucson, AZ, USA.
⁴ University of Arizona Cancer Center, Tucson, AZ, USA.
⁵ SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
⁶ University of Hawaii Cancer Center, Honolulu, HI, USA.
⁷ Research Advocate, SWOG Cancer Research Network, San Antonio, TX, USA.
⁸ University of Washington, Seattle, WA, USA.
⁹ Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
¹⁰ University of Kansas, Kansas City, KS, USA.
¹¹ Perelman School of Medicine, University of Pennsylvania and the Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, PA, USA.
¹² Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, USA.

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.

Abstract

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