Feasibility of an Evidence-based Walking Program in Cancer Pts 60+ During Chemotherapy
WWE
2 other identifiers
observational
29
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 8, 2013
CompletedFirst Posted
Study publicly available on registry
February 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedMarch 20, 2024
March 1, 2024
1.9 years
February 8, 2013
March 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
To measure the rate of completion of each of the following questionnaires/assessments at 3 different time points
1 year
To measure relationships between physical activity levels and p16 levels.
1 year
Study Arms (3)
Breast Cancer Patients 60+
Breast Cancer Patients age 60 and older who have histologically confirmed stage I, II or III disease.
Lung Cancer Patients 60+
Lung Cancer Patients age 60 and above who have stage I, II or III disease
Colon Cancer Patients 60+
Colon cancer patients age 60 and above who have stage II or III disease.
Interventions
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.
* 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.
Eligibility Criteria
Colon, lung and breast cancer patients age 60 and above who are beginning chemotherapy or chemoradiation treatment.
You may qualify if:
- ≥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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina Cancer Hospital
Chapel Hill, North Carolina, 27514, United States
Related Links
Biospecimen
Whole Blood Sample
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyman Muss, MD
University of North Carolina Lineberger Comprehensive Cancer Center
- PRINCIPAL INVESTIGATOR
Kirsten A Nyrop, PhD
University of North Carolina Thurston Arthritis Research Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2013
First Posted
February 12, 2013
Study Start
October 1, 2012
Primary Completion
September 1, 2014
Study Completion
December 1, 2021
Last Updated
March 20, 2024
Record last verified: 2024-03