This trial evaluates the effects a moderate-to-vigorous exercise intervention has on the bacterial make-up of the gastrointestinal tract (gut microbiota) in survivors of stage II-III colorectal cancer (CRC). Data shows that the gut microbiota composition and function may be drivers of CRC. High levels of exercise are associated with improved CRC prognosis and survival. While data suggests that exercise has the potential to influence gut microbiota composition and function, it is not known whether these effects contribute to improved CRC prognosis. This clinical trial evaluates the effects an exercise intervention has on gut microbiota and how these effects relate to CRC progression and patient-reported outcomes.
OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive the supervised exercise intervention 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 a session of supervised exercise followed by 7 weeks of tele-coaching sessions. Patients also undergo collection of blood samples on study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
Undergo collection of blood samples
Receive exercise intervention
Receive tele-coaching intervention
Receive health-related information
Ancillary studies
Ancillary studies
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
RECRUITINGRecruitment
Recruitment (accrual rate) will be assessed to determine feasibility. Will be summarized using descriptive statistics.
Time frame: Up to 8 weeks
Adherence
Adherence will be measured by session attendance in the intervention arm to determine feasibility. Will be summarized using descriptive statistics.
Time frame: Up to 8 weeks
Retention
Retention will be measured by completion of all study assessments, including physical activity via accelerometry, 24 hour dietary recalls, and completion of the follow-up data collection at 8 weeks to determine feasibility. Will be summarized using descriptive statistics. Statistical differences in retention rates for each study assessment between study arms will be assessed by logistic regression models and acceptability by linear regression models, with models adjusted for stratification factors.
Time frame: Up to 8 weeks
Acceptability
Acceptability will be measured on a Likert scale in each of a series of questions regarding various aspects of the trial during the exit interview to determine feasibility. Will be summarized using descriptive statistics.
Time frame: Up to 8 weeks
Effects of an 8 week supervised exercise intervention on fecal concentrations of butyrate
Will be summarized using descriptive statistics, and statistical differences between study arms will be assessed via linear regression models with adjustment for baseline outcome values and stratification factors.
Time frame: At 8 weeks
Effects of an 8 week supervised exercise intervention on fecal concentrations of other short chain fatty acids
Will be summarized using descriptive statistics, and statistical differences between study arms will be assessed via linear regression models with adjustment for baseline outcome values and stratification factors.
Time frame: At 8 weeks
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