- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02191969
Physical Activity Intervention for Older Patients During Chemotherapy for Colorectal Cancer
The Impact of a Physical Activity Intervention in Older Patients Undergoing Adjuvant Chemotherapy for Colorectal Cancer: a Randomized, Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ≥ Age 60 years (no upper age limit)
- Diagnosis of stage II-III colon or rectal cancer planned for treatment with adjuvant chemotherapy scheduled as part of standard treatment
- Able to read English (required for CGA and other surveys administered)
- Approval from their treating physician to engage in moderate-intensity physical activity
- Patient-assessed ability to walk and engage in moderate physical activity
- Signed, IRB-approved written informed consent
Exclusion Criteria:
- Other active, invasive malignancy requiring ongoing therapy or expected to require systemic therapy
- Already walking or engaging in other physical activity >120 minutes per week as documented via subject self-report
- Unable to walk or engage in moderate-intensity physical activity
- One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
This group will be receiving adjuvant chemotherapy for colorectal cancer.
They will not participate in the Walk With Ease program.
They will be followed up using standard of care.
|
|
Experimental: Intervention
This group will be receiving adjuvant chemotherapy for colorectal cancer. They will participate in the Walk With Ease (WWE) program during the course of their chemotherapy treatment. They will be requested to initiate the WWE starting on Day 1 of adjuvant chemotherapy. Participants are asked to walk at a safe and comfortable pace, increasing their minutes per day at a rate they can sustain, with the ultimate goal of 30 minutes/day for at least 5 days/week. They are asked to maintain a daily walking log that is provided to them, entering total minutes per day. Participants will be asked to do the walking program independently (self-directed, not in a formal group with an instructor) throughout chemotherapy. |
A self-directed walking intervention developed by the Arthritis Foundation.
The intervention is a workbook that coaches participants through walking regularly at a safe, comfortable pace with the ultimate goal of walking at least 30 minutes a day five days a week.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To measure the change in fatigue after three months between the intervention and control arm
Time Frame: Three Months
|
The investigators will compare the change in fatigue from baseline to 3 months between Intervention and Control arms as measured via PROMIS®-Fatigue.
|
Three Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To measure changes in physical function at baseline between the intervention and control groups.
Time Frame: 4 to 24 weeks
|
To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms. • Physical function as measured by PROMIS-PF and SPPB |
4 to 24 weeks
|
To measure adherence to the physical activity intervention
Time Frame: One Year
|
To report on the adherence of the physical activity intervention as measured through self-reported minutes of walking per days and walking minutes per week in the group randomized to the Intervention arm
|
One Year
|
To measure the difference in p16INK4a levels before and after chemotherapy in the control and intervention groups
Time Frame: One Year
|
The investigators will comparee the change in p16INK4a and muscle mass measurements pre/post adjuvant chemotherapy between Intervention and Control groups
|
One Year
|
To measure the change in muscle mass measurements before and after chemotherapy between the intervention and control arms
Time Frame: One Year
|
The investigators will compare the change in p16INK4a and muscle mass measurements pre/post adjuvant chemotherapy between Intervention and Control groups
|
One Year
|
To measure the association of p16INK4a and muscle mass with any differences in fatigue o physical function or QOL during chemotherapy
Time Frame: Six months
|
To explore the association of baseline measurements of p16INK4a and muscle mass with changes in fatigue, physical function, and health related quality of life during adjuvant chemotherapy.
|
Six months
|
To measure changes in Quality of Life at baseline between the intervention and control groups.
Time Frame: 4 to 24 weeks
|
To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms. Quality of life as measured by FACT-FCSI and PROMIS-PI |
4 to 24 weeks
|
To measure changes in ADLs at baseline between the intervention and control groups.
Time Frame: 4 to 24 weeks
|
To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms. ADLs per CGA |
4 to 24 weeks
|
To measure changes in Instrumental Activities of Daily Living at baseline between the intervention and control groups.
Time Frame: 4 to 24 weeks
|
To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms. IADLs per CGA |
4 to 24 weeks
|
To measure changes in Self-Efficacy at baseline between the intervention and control groups.
Time Frame: 4 to 24 weeks
|
To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms. Self-efficacy and attitudes as measured by PSEFSM and OEE |
4 to 24 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Hy Muss, MD, UNC Lineberger Comprehensive Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCCC1324
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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