Back to resultsPhysical Activity Intervention for Older Patients During Chemotherapy for Colorectal Cancer
Primary Purpose
Colorectal Cancer, Fatigue
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Walk With Ease
Sponsored by
About this trial
This is an interventional supportive care trial for Colorectal Cancer focused on measuring Chemotherapy, Adjuvant Chemotherapy, Cancer Therapy, Fatigue, Physical Activity, Physical Function, Tiredness, Colon Cancer, Rectal Cancer, Walk With Ease, Colorectal Cancer, Geriatric Assessment, Geriatric, Elderly
Eligibility Criteria
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
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
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
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.
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
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
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
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
Full Information
NCT ID
NCT02191969
First Posted
June 17, 2014
Last Updated
April 29, 2020
Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
LCCC Geriatric Oncology Program
1. Study Identification
Unique Protocol Identification Number
NCT02191969
Brief Title
Physical Activity Intervention for Older Patients During Chemotherapy for Colorectal Cancer
Official Title
The Impact of a Physical Activity Intervention in Older Patients Undergoing Adjuvant Chemotherapy for Colorectal Cancer: a Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
September 18, 2019 (Actual)
Study Completion Date
September 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
LCCC Geriatric Oncology Program
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Fatigue
Keywords
Chemotherapy, Adjuvant Chemotherapy, Cancer Therapy, Fatigue, Physical Activity, Physical Function, Tiredness, Colon Cancer, Rectal Cancer, Walk With Ease, Colorectal Cancer, Geriatric Assessment, Geriatric, Elderly
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Walk With Ease
Other Intervention Name(s)
WWE
Intervention Description
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.
Primary Outcome Measure Information:
Title
To measure the change in fatigue after three months between the intervention and control arm
Description
The investigators will compare the change in fatigue from baseline to 3 months between Intervention and Control arms as measured via PROMIS®-Fatigue.
Time Frame
Three Months
Secondary Outcome Measure Information:
Title
To measure changes in physical function at baseline between the intervention and control groups.
Description
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
Time Frame
4 to 24 weeks
Title
To measure adherence to the physical activity intervention
Description
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
Time Frame
One Year
Title
To measure the difference in p16INK4a levels before and after chemotherapy in the control and intervention groups
Description
The investigators will comparee the change in p16INK4a and muscle mass measurements pre/post adjuvant chemotherapy between Intervention and Control groups
Time Frame
One Year
Title
To measure the change in muscle mass measurements before and after chemotherapy between the intervention and control arms
Description
The investigators will compare the change in p16INK4a and muscle mass measurements pre/post adjuvant chemotherapy between Intervention and Control groups
Time Frame
One Year
Title
To measure the association of p16INK4a and muscle mass with any differences in fatigue o physical function or QOL during chemotherapy
Description
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.
Time Frame
Six months
Title
To measure changes in Quality of Life at baseline between the intervention and control groups.
Description
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
Time Frame
4 to 24 weeks
Title
To measure changes in ADLs at baseline between the intervention and control groups.
Description
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
Time Frame
4 to 24 weeks
Title
To measure changes in Instrumental Activities of Daily Living at baseline between the intervention and control groups.
Description
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
Time Frame
4 to 24 weeks
Title
To measure changes in Self-Efficacy at baseline between the intervention and control groups.
Description
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
Time Frame
4 to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hy Muss, MD
Organizational Affiliation
UNC Lineberger Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25827253
Citation
Williams GR, Nyrop KA, Deal AM, Muss HB, Sanoff HK. Self-directed physical activity intervention in older adults undergoing adjuvant chemotherapy for colorectal cancer: Design of a randomized controlled trial. Contemp Clin Trials. 2015 May;42:90-7. doi: 10.1016/j.cct.2015.03.008. Epub 2015 Mar 28.
Results Reference
derived
Links:
URL
https://unclineberger.org/patientcare/programs/geriatric
Description
The Geriatric Oncology Research Program at UNC
Learn more about this trial
Physical Activity Intervention for Older Patients During Chemotherapy for Colorectal Cancer
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