Overview

This trial is active, not recruiting.

Conditions breast cancer, colon cancer, lung cancer
Treatments walk with ease program, collect blood, ga and other survey tools
Sponsor UNC Lineberger Comprehensive Cancer Center
Start date October 2012
End date September 2014
Trial size 29 participants
Trial identifier NCT01789983, 12-1975, LCCC1226

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Breast Cancer Patients age 60 and older who have histologically confirmed stage I, II or III disease.
walk with ease program WWE
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.
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 age 60 and above who have stage I, II or III disease
walk with ease program WWE
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.
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 age 60 and above who have stage II or III disease.
walk with ease program WWE
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.
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.

Primary Outcomes

Measure
To measure the feasibility of implementing the WWE program among cancer patients, age ≥60, as they undergo cytotoxic chemotherapy treatment.
time frame: 1 year

Secondary Outcomes

Measure
To measure the rate of completion of each of the following questionnaires/assessments at 3 different time points
time frame: 1 year
To measure relationships between physical activity levels and p16 levels.
time frame: 1 year

Eligibility Criteria

Male or female participants at least 60 years old.

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

Additional Information

Official title Feasibility of an Evidence-based Walking Program in a Sample of Cancer Patients >60 Years of Age Undergoing Cytotoxic Chemotherapy
Principal investigator Hyman Muss, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center.