SWOG clinical trial number
S1820

A Randomized Trial of the Altering Intake, Managing Symptoms Intervention for Bowel Dysfunction in Rectal Cancer Survivors Compared to a Healthy Living Education Control: A Feasibility and Preliminary Efficacy Study (AIMS-RC)

Closed
Phase
II
Accrual
100%
Abbreviated Title
AIMS-RC
Activated
12/09/2019
Participants
ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Research committees

Palliative and End of Life Care Committee

Other Study Materials

Eligibility Criteria Expand/Collapse

See Section 18.5 for COVID-19 related exceptions.

Disease Related Criteria
a. Patients must have prior history of rectosigmoid colon cancer, rectal cancer, or sigmoid colon cancer. For patients with sigmoid colon cancer, there must be documentation of either partial proctectomy and/or anastomosis to the rectum.
b. Patients must have a post-surgical permanent ostomy or anastomosis.

Prior/Concurrent Therapy Criteria
a. Patient’s last date of treatment for rectal cancer (any surgery, chemotherapy, radiation therapy) must be at least 6 months prior to registration and not more than 24 months prior to registration.

Clinical/Laboratory Criteria
a. Anastomosis patients must have low anterior resection syndrome (LARS) score of 21-42 (minor to major symptoms) within 7calendar days prior to registration.
b. Patient must have completed all baseline questionnaires within 7 days prior to registration.
c. The S1820 Patient Contact form must be completed prior to patient registration.
d. Patients must be able to read, write and speak English. Study materials and telephone calls are only available in English.
e. Patients must be ≥ 18 years of age.
f. Patients with a prior malignancy (other than as noted in Section 5.1a) or concurrent malignancy that is currently not being treated, whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
g. Patients who are currently undergoing treatment for another cancer will have a different symptom profile than what this study is targeting and are not eligible.
h. Patients who have been diagnosed with inflammatory bowel disease (IBD), such as ulcerative colitis or Crohn’s disease, are not eligible.

Publication Information Expand/Collapse

2022

Altering Intake and Managing Symptoms (AIMS): Feasibility of a Diet Modification Intervention for Post-Treatment Bowel Dysfunction in Rectal Cancer [S1820 Pilot]

V Sun;T Crane;S Freylersythe;S Slack;A Yung;R Krouse;C Thomson Clinical Journal of Oncology Nursing Jun 1;26(3):283-292

PMid: PMID35604741 | PMC number: https://pubmed.ncbi.nlm.nih.gov/35604741/

2021

SWOG S1820: Altering Intake, Managing Symptoms for Bowel Dysfunction in Survivors of Rectal Cancer (The AIMS-RC Intervention Trial)

V Sun;T Crane;K Arnold;K Guthrie;S Freylersythe;C Braun-Inglis;L Jones;S Cohen;M Al-Kasspooles;R Krouse;C Thomson Contemporary Clinical Trials Apr 8;22:100768. doi: 10.1016/j.conctc.2021.100768. eCollection 2021 Jun.

PMid: PMID33997460 | PMC number: PMC8105629