Back to resultsPredictors of Physical Activity Maintenance in Colorectal Cancer Survivors
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Group Exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Colorectal Cancer focused on measuring Physical activity, Survivors, Maintenance, Personal Training, Group Mediated Cognitive Behavior
Eligibility Criteria
Inclusion Criteria:
- Provision to sign and date the consent form
- Fluent in English
- Have access to a computer or phone with internet and a camera
- Stated willingness to comply with all study procedures and be available for the duration of the study
- Be a male or female aged 40 years or older at time of diagnosis
- Histologically confirmed cancer of the colon or rectum (stages II-IV) if treated with curative intent, and no current evidence of metastatic disease
- Completed resection or other surgery 3-24 months prior to enrollment
- 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:
- Current evidence of metastatic disease
- Existing participation in ≥150 minutes per week of at least moderate intensity PA
- Known contraindications for exercise or not able to safely participate in exercise
- Pregnant women (no testing required)
Sites / Locations
- University of Colorado Denver
- Poudre Valley Hospital
- Colorado State University
- Harmony Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group-based exercise
Control Group
Arm Description
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.
A physical activity education control group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Physical Fitness: Strength and Endurance
Muscular strength & endurance will be assessed by various weight training activities.
Body Composition
Assessed by waist circumference
Body Composition
Assessed by the combination of lean mass and fat mass via Dual-Energy X-ray Absorptiometry (DEXA)
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.
Quality of Life Assessment
Assessed by a quantitative self-report questionnaire (Functional Assessment of Cancer Therapy-Colorectal (FACT-C)
Full Information
NCT ID
NCT03781154
First Posted
December 14, 2018
Last Updated
August 31, 2023
Sponsor
University of Colorado, Denver
Collaborators
American Cancer Society, Inc., Colorado State University
1. Study Identification
Unique Protocol Identification Number
NCT03781154
Brief Title
Predictors of Physical Activity Maintenance in Colorectal Cancer Survivors
Official Title
Predictors of Physical Activity Maintenance in Colorectal Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 17, 2019 (Actual)
Primary Completion Date
June 26, 2023 (Actual)
Study Completion Date
June 26, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
American Cancer Society, Inc., Colorado State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Physical activity, Survivors, Maintenance, Personal Training, Group Mediated Cognitive Behavior
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients will be prospectively assigned or allocated to either the group-based exercise intervention or control group for 12 weeks.
Masking
InvestigatorOutcomes Assessor
Masking Description
PI and study staff conducting assessments at study visits will be blinded to study arm assignment.
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group-based exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
A physical activity education control group
Intervention Type
Behavioral
Intervention Name(s)
Group Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical Activity
Description
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.
Time Frame
From baseline to 12-weeks, and 6 months post intervention
Secondary Outcome Measure Information:
Title
Physical Fitness: Aerobic
Description
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.
Time Frame
From baseline to 12-weeks and 6-months post intervention
Title
Physical Fitness: Strength and Endurance
Description
Muscular strength & endurance will be assessed by various weight training activities.
Time Frame
From baseline to 12-weeks and 6 months post intervention
Title
Body Composition
Description
Assessed by waist circumference
Time Frame
From baseline to 12-weeks 6 months post intervention
Title
Body Composition
Description
Assessed by the combination of lean mass and fat mass via Dual-Energy X-ray Absorptiometry (DEXA)
Time Frame
From baseline to 12 weeks
Title
Sleep Quality
Description
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.
Time Frame
From baseline to 12 weeks
Title
Quality of Life Assessment
Description
Assessed by a quantitative self-report questionnaire (Functional Assessment of Cancer Therapy-Colorectal (FACT-C)
Time Frame
From baseline to 12 weeks and 6 months post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision to sign and date the consent form
Fluent in English
Have access to a computer or phone with internet and a camera
Stated willingness to comply with all study procedures and be available for the duration of the study
Be a male or female aged 40 years or older at time of diagnosis
Histologically confirmed cancer of the colon or rectum (stages II-IV) if treated with curative intent, and no current evidence of metastatic disease
Completed resection or other surgery 3-24 months prior to enrollment
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:
Current evidence of metastatic disease
Existing participation in ≥150 minutes per week of at least moderate intensity PA
Known contraindications for exercise or not able to safely participate in exercise
Pregnant women (no testing required)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wells Messersmith, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Poudre Valley Hospital
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
800524
Country
United States
Facility Name
Colorado State University
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80523
Country
United States
Facility Name
Harmony Campus
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Predictors of Physical Activity Maintenance in Colorectal Cancer Survivors
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