Predictors of Physical Activity Maintenance in Colorectal Cancer Survivors

Phase 3

Completed

• Conditions: Colorectal Cancer
• Interventions: Behavioral: Group Exercise

• Registration Number: NCT03781154
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-12-14
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Study Start: 2019-10-17
• Primary Completion: 2023-06-26
• Study Completion: 2023-06-26
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Provision to sign and date the consent form
2. Fluent in English
3. Have access to a computer or phone with internet and a camera
4. Stated willingness to comply with all study procedures and be available for the duration of the study
5. Be a male or female aged 40 years or older at time of diagnosis
6. Histologically confirmed cancer of the colon or rectum (stages II-IV) if treated with curative intent, and no current evidence of metastatic disease
7. Completed resection or other surgery 3-24 months prior to enrollment
8. Received chemotherapy and/or radiation therapy within the previous year, with at least 1 cycle of intended chemotherapy completed (does not need to complete all cycles). No plans for additional chemotherapy or radiation therapy.

Exclusion Criteria

1. Current evidence of metastatic disease
2. Existing participation in ≥150 minutes per week of at least moderate intensity PA
3. Known contraindications for exercise or not able to safely participate in exercise
4. Pregnant women (no testing required)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group-based exercise	Group Exercise	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.

Primary Outcome Measures

Name	Time	Method
Physical Activity	From baseline to 12-weeks, and 6 months post intervention	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.

Secondary Outcome Measures

Name	Time	Method
Body Composition	From baseline to 12 weeks	Assessed by the combination of lean mass and fat mass via Dual-Energy X-ray Absorptiometry (DEXA)
Physical Fitness: Aerobic	From baseline to 12-weeks and 6-months post intervention	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.
Sleep Quality	From baseline to 12 weeks	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.
Physical Fitness: Strength and Endurance	From baseline to 12-weeks and 6 months post intervention	Muscular strength \& endurance will be assessed by various weight training activities.
Quality of Life Assessment	From baseline to 12 weeks and 6 months post intervention	Assessed by a quantitative self-report questionnaire (Functional Assessment of Cancer Therapy-Colorectal (FACT-C)

Trial Locations

Locations (4)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States

Colorado State University; 🇺🇸 Fort Collins, Colorado, United States

Harmony Campus; 🇺🇸 Fort Collins, Colorado, United States

Poudre Valley Hospital; 🇺🇸 Fort Collins, Colorado, United States