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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01046 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2017-1035 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies how well cycling works in preventing colorectal cancer in participants with Lynch syndrome. Exercise such as cycling may reduce colorectal cancer risk in participants with Lynch syndrome.
PRIMARY OBJECTIVES:
I. To assess the feasibility of a 12-month exercise cycling intervention among Lynch syndrome (LS) patients.
SECONDARY OBJECTIVES:
I. To assess the effect size of exercise on circulating biomarkers as well as regulation of genomic, transcriptomic, and immunologic biomarkers in normal intestinal mucosa of LS patients.
OUTLINE: Participants are assigned to 1 of 2 groups.
GROUP I: Starting on day 15, participants wear FITBIT and complete cycling classes over 45 minutes 3 times a week for a total of 12 classes a month for up to 1 year.
GROUP II: Starting on day 15, participants receive information about exercise guidelines and wear FITBIT to track heart rate and activities for up to 1 year.
After completion of study interventions, participants are followed up at 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (FITBIT, cycling) | Experimental | Starting on day 15, participants wear FITBIT and complete cycling classes over 45 minutes 3 times a week for a total of 12 classes a month for up to 1 year. |
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| Group II (FITBIT, information) | Active Comparator | Starting on day 15, participants receive information about exercise guidelines and wear FITBIT to track heart rate and activities for up to 1 year. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Behavioral | Complete cycling classes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Defined as the proportion of eligible patients who consent to the number of patients who are contacted. This study will be considered as feasible if the recruitment rate is at least 20%. | Up to 1 year |
| Adherence rate | Defined as the proportion of the actual attendance number to the planned number of exercise sessions (12 sessions monthly x 12 months) where patients will be required to comply with duration (time) of each session participated as well as monthly attendance. This study will be considered as feasible if the adherence rate is at least 75%. | Up to 1 year |
| Retention | Defined as the proportion of participants who stay until study completion. This study will be considered as feasible if the retention rate is at least 75%. | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo Vilar-Sanchez, BLS,MD,PHD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| Informational Intervention |
| Other |
Receive information about exercise guidelines |
|
| Monitoring Device | Device | Wear Fitbit |
|
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| Questionnaire Administration | Other | Complete questionnaire |
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| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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