NCT01789983

Feasibility of an Evidence-based Walking Program in Cancer Pts 60+ During Chemotherapy

Feasibility of an Evidence-based Walking Program in a Sample of Cancer Patients >60 Years of Age Undergoing Cytotoxic Chemotherapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 29 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The study will look at conducting a medium-intense walking program called Walk With Ease with cancer patients age 60 and above who are starting chemotherapy treatment. We will measure how many of these patients complete their participation in this program.

Detailed description

The primary purpose of this study is to evaluate the feasibility of implementing a moderate-intensity walking program (Walk With Ease/WWE) among cancer patients, age ≥60 years, as they undergo cytotoxic chemotherapy treatment. Feasibility will be determined based on the rate of participation in the WWE program. As secondary objectives, we will also establish the rate of completion of a number of instruments, including a Geriatric Assessment tool, and other instruments that measure self-reported quality of life (e.g., fatigue, depression, and pain), and self-reported physical activity (PA). Data from these instruments, as well as from serial measurements of a biomarker of aging (p16INK4a) will be explored and used to inform future studies designed to evaluate any relationship between these variables and participation in the WWE program. We propose a sample (n=30) of cancer patients ≥60 years of age with potentially curable cancer and a diagnosis of Stage I-III breast cancer, Stage I-III lung cancer, or Stage II-III colon cancer, who are about to begin chemotherapy. Participation will be defined as completing the 6-week WWE program. Results from this study will be used in an RO1 application to the National Cancer Institute (NCI) pertaining to PA interventions among cancer patients and the effects of biomarkers on prognosis and survival.

Conditions

• Breast Cancer
• Colon Cancer
• Lung Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Walk With Ease Program	The primary activity required of study subjects is a 6-week self-directed (non-group) WWE walking program that study participants do at a place and time that is convenient for them. To start the intervention/program, we schedule a brief baseline meeting with study participants to discuss the program, provide the WWE workbook, secure printed informed consent, and complete various questionnaires. Study participants are also asked to maintain a daily walking diary that is provided to them. The WWE program includes a workbook with strengthening and stretching exercises, basic facts about arthritis and PA, and information on how to individualize the program.
OTHER	Collect Blood, GA and Other Survey Tools	* Geriatric Assessment (GA) (Version 5) * Functional Assessment of Cancer Therapy-General (FACT) * Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue36 * Outcome Expectations for Exercise (OEE) scale29 * Self-Efficacy to Manage Arthritis or Joint Pain (ASE/Arthritis Self-Efficacy) * Perceived Self-Efficacy for Fatigue Self-Management (PSEFSM)34,35 * Visual Analog Scales (VAS) Surveys included in study are listed above. Whole Blood Sample will be collected for p16 analysis.

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-09-01
• Completion: 2021-12-01
• First posted: 2013-02-12
• Last updated: 2024-03-20

Locations

1 site across 1 country: United States