Breast Cancer Clinical Trial

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

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.

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Full 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.

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Eligibility Criteria

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 is for people with:

Breast Cancer

Estimated Enrollment:

29

Study ID:

NCT01789983

Recruitment Status:

Completed

Sponsor:

UNC Lineberger Comprehensive Cancer Center

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There is 1 Location for this study

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

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Study is for people with:

Breast Cancer

Estimated Enrollment:

29

Study ID:

NCT01789983

Recruitment Status:

Completed

Sponsor:


UNC Lineberger Comprehensive Cancer Center

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