Physical Activity Intervention for Older Patients During Chemotherapy for Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191969
• Other study ID #: LCCC1324
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: September 18, 2019

Study information

• Verified date: November 2019
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 18, 2019
• Est. primary completion date: September 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Fatigue

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	LCCC Geriatric Oncology Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	4 to 24 weeks
Secondary	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	One Year
Secondary	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	One Year
Secondary	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	One Year
Secondary	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.	Six months
Secondary	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	4 to 24 weeks
Secondary	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	4 to 24 weeks
Secondary	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	4 to 24 weeks
Secondary	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	4 to 24 weeks

External Links

•   The Geriatric Oncology Research Program at UNC