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


N/A
60 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Colon Cancer, Lung Cancer

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To measure the feasibility of implementing the WWE program among cancer patients, age ≥60, as they undergo cytotoxic chemotherapy treatment.

Outcome Description:

Feasibility will be defined as the proportion of recruited subjects who complete the 6-week WWE program.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Hyman Muss, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina Lineberger Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

LCCC1226

NCT ID:

NCT01789983

Start Date:

October 2012

Completion Date:

October 2014

Related Keywords:

  • Breast Cancer
  • Colon Cancer
  • Lung Cancer
  • Physical Activity
  • Chemotherapy
  • Elderly
  • Geriatric
  • Walking
  • Geriatric Assesment
  • Geriatric Oncology
  • Breast Neoplasms
  • Colonic Neoplasms
  • Lung Neoplasms

Name

Location

University of North Carolina Cancer HospitalChapell Hill, North Carolina  27514