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)

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.