Physical Activity Intervention for Older Patients During Chemotherapy for Colorectal Cancer

NCT ID: NCT02191969

Last Updated: 2020-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2019-09-18

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.

Conditions

Colorectal Cancer; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Walk With Ease

Intervention Type: 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.

Interventions

Walk With Ease

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

WWE

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LCCC Geriatric Oncology Program

UNKNOWN

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hy Muss, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25827253 (View on PubMed)

Related Links

https://unclineberger.org/patientcare/programs/geriatric

The Geriatric Oncology Research Program at UNC

Other Identifiers

LCCC1324

Identifier Type: -

Identifier Source: org_study_id