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NCT Number: NCT01789983

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

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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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Motor Activity Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of North Carolina Cancer Hospital

Chapel Hill, North Carolina, 27514, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walk with Ease Program

Behavioral

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 names: WWE

Collect Blood, GA and Other Survey Tools

Other
  • 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

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

    Time frame: 1 year

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

Secondary outcomes

  1. To measure the rate of completion of each of the following questionnaires/assessments at 3 different time points

    Time frame: 1 year

    The rate of completion of assessments will be measured at baseline, 6 weeks and end of chemotherapy treatment.

  2. To measure relationships between physical activity levels and p16 levels.

    Time frame: 1 year

    To measure the association between number of minutes walked per day and number of times per week with p16 levels.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Official study title

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

Acronym: WWE

Important dates

Study start
2012
Primary completion
2014
Study completion
2021
First posted
Feb 12, 2013
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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