Physical Activity Intervention for Older Patients During Chemotherapy for Colorectal Cancer

NCT02191969 | Completed DMC

• 1 other identifier: LCCC1324
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• To measure changes in physical function at baseline between the intervention and control groups.

  4 to 24 weeks

• To measure adherence to the physical activity intervention

  One Year

• To measure the difference in p16INK4a levels before and after chemotherapy in the control and intervention groups

  One Year

• To measure the change in muscle mass measurements before and after chemotherapy between the intervention and control arms

  One Year

• To measure the association of p16INK4a and muscle mass with any differences in fatigue o physical function or QOL during chemotherapy

  Six months

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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

Interventions

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.

Also known as: WWE

Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• LCCC Geriatric Oncology Program: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• 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.

  PMID: 25827253 DERIVED

Related Links

• The Geriatric Oncology Research Program at UNC

MeSH Terms

Conditions

Colorectal Neoplasms; Fatigue; Motor Activity; Colonic Neoplasms; Rectal Neoplasms

Interventions

Walking; methyl hydroxyethyl cellulose

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Hy Muss, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: July 16, 2014
• Study Start: June 1, 2014
• Primary Completion: September 18, 2019
• Study Completion: September 18, 2019
• Last Updated: May 1, 2020

Record last verified: 2019-11

Locations

US (1)