Physical Activity Intervention for Older Patients During Chemotherapy for Colorectal Cancer

Study Overview
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Brief Summary
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This study will see if patient who undergo a physical activity intervention called Walk With Ease report experiencing less fatigue and a higher quality of life during chemotherapy for colorectal cancer than those who do not participate in this intervention.

Detailed Description
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The primary purpose of this multicenter, randomized controlled study is to evaluate the impact of a physical activity program on fatigue in older patients (≥60 years) undergoing adjuvant chemotherapy for colorectal cancer. The investigators also plan to evaluate physical function and quality of life as secondary objectives. The investigators' hypotheses are that people who undergo the physical activity intervention compared to those who do not, will: 1) report less fatigue, 2) report higher health related quality of life, and 3) have less decline in physical function. Additionally, The investigators will characterize ≥grade 3 adjuvant chemotherapy associated toxicities in this older population, and describe the changes reported in fatigue, physical function, and HRQOL over the course of chemotherapy.

Official Title
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The Impact of a Physical Activity Intervention in Older Patients Undergoing Adjuvant Chemotherapy for Colorectal Cancer: a Randomized, Controlled Trial

Conditions
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Colorectal Cancer, Fatigue

Intervention / Treatment
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* Behavioral: Walk With Ease


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>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. | Behavioral: Walk With Ease<br>* 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.<br>* Other names: WWE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the change in fatigue after three months between the intervention and control arm | 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. | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colon Cancer, Rectal Cancer, Walk With Ease, Colorectal Cancer, Chemotherapy, Adjuvant Chemotherapy, Cancer Therapy, Fatigue, Physical Activity, Physical Function, Tiredness, Geriatric Assessment, Geriatric, Elderly