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

Breast Cancer Clinical Trial

— WWE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789983
• Other study ID #: LCCC1226
• Secondary ID: 12-1975
• Status: Completed
• Start date: October 2012
• Est. completion date: December 2021

Study information

• Verified date: March 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2021
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer
• Colonic Neoplasms
• Lung Cancer

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	University of North Carolina Cancer Hospital	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   The Geriatric Oncology Research Program at UNC