Page 11 - Delaware Medical Journal - November/December 2020

CANCER CLINICAL TRIAL
CTSU S1820: 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)
The objectives of the trial are:
Primary Objectives:
• To compare total bowel function score, as measured by the Memorial Sloan Kettering Cancer Center Bowel Function Instrument (BFI), at 18 weeks post-randomization between the intervention and attention control arms.
Exploratory Objectives:
• To compare total bowel function score at 26 weeks post-randomization between the intervention and attention control arms.
• To compare bowel function subscale scores (dietary, urgency, frequency), as measured by the BFI at both 18 and 26 weeks post- randomization between the intervention and attention control arms.
• To compare lower anterior resection syndrome (LARS) scores (for anastomosis participants only), quality of life, and dietary quality at both 18 and 26 weeks post-randomization between the intervention and attention control arms.
• To compare motivation, self-efficacy, and positive/negative affect at both 18 and 26 weeks post-randomization between the intervention and attention control arms.
• To assess study feasibility, adherence, retention, and acceptability at both 18 and 26 weeks post-randomization.
• To explore variation in primary and exploratory study outcomes according to sex, and to investigate whether intervention effects on the primary outcome differ across subgroups defined by sex.
Eligibility:
Prior to Step 1 registration, patients must meet the following criteria:
Disease Related Criteria:
• Patients must have prior history of rectosigmoid colon cancer or rectal cancer.
• Patients must have a post-surgical permanent ostomy or anastomosis.
Clinical/Laboratory Criteria:
• Anastomosis patients must have low anterior resection syndrome (LARS) score of 21-42 (minor to major symptoms) within 5 calendar days prior to registration.
• Patient must have completed all baseline questionnaires within 5 days prior to registration.
• The S1820 Patient Contact form must be completed prior to patient registration.
• Patients must be able to read, write, and speak English. Patients must be ≥ 18 years of age.
• Patient has received an autologous bone marrow transplant within the past 2 years.
• 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.
Eligibility:
Prior to Step 2 registration, patients must meet the following criteria:
Clinical/Laboratory Criteria:
• Patient must have successfully completed (“pass”) the run-in period, as per email notification from the University of Arizona.
• Patient must be registered to Step 2 no more than 40 days after Step 1 registration. If Day 40 falls on a weekend or holiday, the limit may be extended to the next working day.
Patient Participation:
• 6-monthduration
• Telephone intervention administered from a central call center by trained health coaches
• Intervention group involves dietary and lifestyle modifications versus attention control group
• Participant burden: 3-day food and symptom diary, questionnaires, 10 telephone calls, 1 diet history, and 30 text or email messages.
For information regarding this clinical trial or if you would like to have the list of open protocols emailed
to you, please call the Cancer Research Office at (302) 623-4450 or email akee@christianacare.org.
Del Med J | November/December 2020 | Vol. 92 | No. 6 251