Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 131629-MRSG-18-021- 01-CPPB | Other Identifier | American Cancer Society |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
| Colorado State University | OTHER |
Not provided
Not provided
Not provided
Not provided
This study is a two-arm trial, comparing the effects of a virtual 12-week group-based exercise intervention vs. control group on physical activity, physical fitness, and quality of life in colorectal cancer survivors, and explore multi-level determinants of physical activity maintenance, 6-months after intervention completion.
Participants will be prospectively assigned or allocated to either a the exercise intervention or a control group for 12-weeks. The control group will be provided with an informational handout from the American Cancer Society describing exercise recommendations and guidelines for cancer survivors. At the end of the study, control group participants will be offered compensation for participation in a community-based cancer specific exercise program (e.g., BfitBwell, Fit Cancer, Livestrong at the YMCA). Supervised exercise sessions will take place twice per week for approximately one hour, and include aerobic, muscular strength and endurance, balance, and flexibility components. Sessions will be delivered synchronously (i.e., in real-time/live) via Zoom. Exercise will be individualized based on the results of baseline fitness assessments and medical history. The intervention will also include virtual, group-based discussion sessions which operationalize behavior change techniques to increase physical activity. Discussion sessions will take place in the same groups, synchronously, via Zoom.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group-based exercise | Experimental | Virtually-delivered supervised exercise sessions will take place twice per week for approximately one hour, and include aerobic, muscular strength and endurance, balance, and flexibility components. |
|
| Control Group | No Intervention | A physical activity education control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group Exercise | Behavioral | Patients will exercise in a virtual group for 60 minutes, twice a week. Five social-cognitive theory-based discussion sessions with the group, and group exercise instructor will be held throughout the course of the intervention, lasting 30 to 60 minutes. The goal of these sessions is to enhance long-term physical activity behavior change. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity | Compare the effects of a 12-week physical activity intervention delivered in group versus control group, on physical activity. Physical activity will be measured with a self-report questionnaire (duration and frequency of moderate and vigorous physical activity) and accelerometer. | From baseline to 12-weeks, and 6 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Fitness: Aerobic | Aerobic fitness will be assessed with a submaximal, graded exercise test on a motorized, calibrated treadmill. Muscular Strength & Endurance will be assessed by multiple repetition maximum (1RM) plate loaded seated bench press and leg press, and by the number of full stands from a chair, and the number of bicep curls (holding a hand weight of 5lbs) that can be completed in 30 seconds. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wells Messersmith, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States | ||
| Poudre Valley Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39008350 | Derived | Bachman SL, Gomes E, Aryal S, Cella D, Clay I, Lyden K, Leach HJ. Do Measures of Real-World Physical Behavior Provide Insights Into the Well-Being and Physical Function of Cancer Survivors? Cross-Sectional Analysis. JMIR Cancer. 2024 Jul 15;10:e53180. doi: 10.2196/53180. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Patients will be prospectively assigned or allocated to either the group-based exercise intervention or control group for 12 weeks.
Not provided
Not provided
PI and study staff conducting assessments at study visits will be blinded to study arm assignment.
|
| From baseline to 12-weeks and 6-months post intervention |
| Physical Fitness: Strength and Endurance | Muscular strength & endurance will be assessed by various weight training activities. | From baseline to 12-weeks and 6 months post intervention |
| Body Composition | Assessed by waist circumference | From baseline to 12-weeks 6 months post intervention |
| Body Composition | Assessed by the combination of lean mass and fat mass via Dual-Energy X-ray Absorptiometry (DEXA) | From baseline to 12 weeks |
| Sleep Quality | Assessed by a self-report measure of sleep quality using the Pittsburg Sleep Quality Index (PSQI) and through the Actiwatch, which is a wrist-worn monitor that records movement and light exposure. | From baseline to 12 weeks |
| Quality of Life Assessment | Assessed by a quantitative self-report questionnaire (Functional Assessment of Cancer Therapy-Colorectal (FACT-C) | From baseline to 12 weeks and 6 months post intervention |
| Fort Collins |
| Colorado |
| 800524 |
| United States |
| Colorado State University | Fort Collins | Colorado | 80523 | United States |
| Harmony Campus | Fort Collins | Colorado | 80528 | United States |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001519 | Behavior |