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Completed

NCT Number: NCT02191969

Physical Activity Intervention for Older Patients During Chemotherapy for Colorectal Cancer

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walk With Ease

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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
  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • LCCC Geriatric Oncology Program

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jul 16, 2014
Registry last updated
May 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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