Clinical trial NCT01789983: Feasibility of an Evidence-based Walking Program in Cancer Pts 60+ During Chemotherapy
Official title: Feasibility of an Evidence-based Walking Program in a Sample of Cancer Patients >60 Years of Age Undergoing Cytotoxic Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Colon Cancer
Lung Cancer
Keywords: Physical Activity
Chemotherapy
Elderly
Geriatric
Walking
Geriatric Assessment
Geriatric Oncology
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2013-02-12
Enrollment: 29
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Colon, lung and breast cancer patients age 60 and above who are beginning chemotherapy or chemoradiation treatment.

Brief 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.

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

Primary outcomes:
measure: To measure the feasibility of implementing the WWE program among cancer patients, age ≥60, as they undergo cytotoxic chemotherapy treatment.
timeFrame: 1 year
Secondary outcomes:
measure: To measure the rate of completion of each of the following questionnaires/assessments at 3 different time points
timeFrame: 1 year
measure: To measure relationships between physical activity levels and p16 levels.
timeFrame: 1 year
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Cancer Hospital
state: North Carolina
Study officials:
affiliation: University of North Carolina Lineberger Comprehensive Cancer Center
name: Hyman Muss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina Thurston Arthritis Research Center
name: Kirsten A Nyrop, PhD
role: PRINCIPAL_INVESTIGATOR
References: