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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-03747 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P30CA015704 | U.S. NIH Grant/Contract | View source | |
| 20059 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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 (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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (exercise intervention) | Experimental | Patients receive the supervised exercise intervention (in-person or virtual) TID over 8 weeks on study. Patients also undergo collection of blood samples on study. |
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| Arm B (waitlist control) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood samples |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | Recruitment (accrual rate) will be assessed to determine feasibility. Will be summarized using descriptive statistics. | 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. | 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. | 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. | Up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heather Greenlee | Contact | 206-667-4502 | hgreenlee@fredhutch.org |
| Name | Affiliation | Role |
|---|---|---|
| Heather Greenlee | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Recruiting | Seattle | Washington | 98109 | United States |
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| Exercise Intervention | Other | Receive exercise intervention |
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| Exercise Intervention | Other | Receive tele-coaching intervention |
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| Health Education | Behavioral | Receive health-related information |
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| Interview | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| 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. |
| At 8 weeks |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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