Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Fred Hutchinson Cancer Center
With
National Cancer Institute (NCI)
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive the supervised exercise intervention (in-person or virtual) three times weekly (TID) over 8 weeks on study. Patients also undergo collection of blood samples on study.
ARM B: Patients receive health-related information for 8 weeks on study. Patients are then offered an in-person session of supervised exercise followed by weekly virtual tele-coaching sessions for 7 weeks. Patients also undergo collection of blood samples on study.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
18-70 years of age
Previous diagnosis of stage II-III CRC cancer
No known current, recurrent, or metastatic disease
No comorbid or physical limitations that would limit participation at the discretion of the treating provider
At least 60 days to 3 years from last cancer-directed treatment (including surgery, chemotherapy, and radiation. Elective surgery, including ileostomy reversal, is not counted in this timing but patients must be able to eat a normal diet, without post-operative dietary limitations)
Body mass index (BMI) 18.5-35 kg/m\^2
Able to understand and willing to sign written informed consent in English
Access to phone for study contacts
Access to a smart phone or tablet to connect to the Polar H10 Heart rate sensor during remote exercise sessions and attend virtual exercise sessions
Be willing and able to attend up to 24 sessions in-person at the Fred Hutch Exercise Research Center Shared Resource or virtually via phone, Zoom, or Microsoft Teams, based on participant preference
Access to internet (internet access may be provided on a case-by-case basis to participants where access to internet would otherwise be the only barrier to participation)
Willingness to participate in all study activities
Completion of all run-in activities
Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status score of 0 or 1 for performance status
Women must not be pregnant, breastfeeding, or planning to become pregnant
You may not be if
Use of oral or intravenous antibiotics, antifungals, or antiparasitics during the past 6 months
Presence of an ileostomy or colostomy because of known changes to the gut microbiome with ileostomies and colostomies
Current status of underweight (BMI \< 18.5 kg/m\^2) or class II/III obesity (BMI ≥ 35.0 kg/m\^2)
Presence of inflammatory bowel diseases such as Crohn's disease or ulcerative colitis as these are known to baseline have differences in gut microbiome composition
Women who are pregnant, breastfeeding, or planning to become pregnant
Physician notification to not approach patient for the study
Clareo Health | Evaluating the Effects of an Exercise Intervention on the Gut Microbiota in Stage II-III Colorectal Cancer Survivors
