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)

Open
Phase
II
Accrual
1%
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

Disease Related Criteria:
a. Patients must have prior history of rectosigmoid colon cancer or rectal cancer.
b. Patients must have a post-surgical permanent ostomy or anastomosis.

Prior/Concurrent Therapy Criteria:
Patients 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 5 calendar days prior to registration.
b. Patient must have completed all baseline questionnaires within 5 days prior to registration.
c. Patient must be able to read, write and speak English. Study materials and telephone calls are only available in English.
d. Patient must be >or = 18 years of age.
e. Patient with a prior malignancy 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.
f. 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.
g. Patients who have been diagnosed with inflammatory bowel disease (IBD), such as ulcerative colitis or Crohns disease, are not eligible.

Reports & Approvals

Trial Locations

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