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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Lung Cancer; Colon Cancer
• Intervention / Treatment: Behavioral: Walk With Ease Program; Other: Collect Blood, GA and Other Survey Tools

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.

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Colon, lung and breast cancer patients age 60 and above who are beginning chemotherapy or chemoradiation treatment.

Description

Inclusion Criteria:

• ≥60 years of age, male or female
• Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer diagnosis, then the most recent diagnosis); Stage I, II or III lung cancer, or Stage II or III colon cancer
• Scheduled to begin a chemotherapy (or concomitant chemoradiotherapy) regimen that will last at least 6 weeks in duration
• English speaking
• IRB approved, signed written informed consent
• Approval from their treating physician to engage in moderate-intensity physical activity
• Patient-assessed ability to walk and engage in moderate physical activity
• Willing and able to meet all study requirements.

Exclusion Criteria:

• One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention
• Cancer surgery scheduled within the study period
• Unable to walk or engage in moderate-intensity physical activity

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breast Cancer Patients 60+; Breast Cancer Patients age 60 and older who have histologically confirmed stage I, II or III disease.	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 Names: WWE; 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.
Lung Cancer Patients 60+; Lung Cancer Patients age 60 and above who have stage I, II or III disease	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 Names: WWE; 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.
Colon Cancer Patients 60+; Colon cancer patients age 60 and above who have stage II or III disease.	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 Names: WWE; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure the feasibility of implementing the WWE program among cancer patients, age ≥60, as they undergo cytotoxic chemotherapy treatment.	Feasibility will be defined as the proportion of recruited subjects who complete the 6-week WWE program.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure the rate of completion of each of the following questionnaires/assessments at 3 different time points	The rate of completion of assessments will be measured at baseline, 6 weeks and end of chemotherapy treatment.	1 year
To measure relationships between physical activity levels and p16 levels.	To measure the association between number of minutes walked per day and number of times per week with p16 levels.	1 year

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Hyman Muss, MD, University of North Carolina Lineberger Comprehensive Cancer Center; Principal Investigator: Kirsten A Nyrop, PhD, University of North Carolina Thurston Arthritis Research Center

Publications and helpful links

Helpful Links

• The Geriatric Oncology Research Program at UNC

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: February 8, 2013
• First Submitted That Met QC Criteria: February 8, 2013
• First Posted (Estimated): February 12, 2013

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Elderly; Physical Activity; Chemotherapy; Walking; Geriatric; Geriatric Assessment; Geriatric Oncology
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: LCCC1226; 12-1975 (Other Identifier: UNC IRB)