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

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • WWE

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hy Muss, MD, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

September 18, 2019

Study Completion (Actual)

September 18, 2019

Study Registration Dates

First Submitted

June 17, 2014

First Submitted That Met QC Criteria

July 14, 2014

First Posted (Estimate)

July 16, 2014

Study Record Updates

Last Update Posted (Actual)

May 1, 2020

Last Update Submitted That Met QC Criteria

April 29, 2020

Last Verified

November 1, 2019

More Information

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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