Evaluating a Physical Activity Index for Assessment and Counseling for Breast and Colon Cancer Survivors
- Conditions
- Breast CancerColon Cancer
- Registration Number
- NCT06340503
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
The purpose of this research study is to determine whether using the physical activity index screener, exercise coaching, and self-monitoring will increase physical activity and reduce time spent sitting or being inactive in patients who had breast or colon cancer.
- Detailed Description
To assess the feasibility (participation rate, adherence, and retention) of the Physical Activity Index (PAI) intervention in breast and colon cancer survivors supported by exercise coaching and self-monitoring tools.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Survivors of breast or colon cancer (stages 0-III) diagnosed within the last three years prior to enrollment.
- Completed primary treatment (surgery, chemotherapy, and/or radiation) at least 3 months prior to enrollment.
- At least 50 years of age or older.
- Access to internet or cellular plan for video calls.
- Being willing and able to comply with the approved protocol and able to sign an IRB-approved informed consent document directly, remotely or via electronic consent.
- Able to read and speak English
- Participants with metastatic disease.
- Participants with recurrence or diagnosis of a different cancer.
- Participants receiving treatment other than maintenance therapy for their primary cancer (breast or colon).
- Participants has prior conditions that contraindicate exercise as determined by treating physician.
- Participants has gross cognitive impairment as determined by treating physician.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of Eligible Participants - Participation Rate 17 months Participation will be measured by the number of eligible participants who agree to participate. Investigators will calculate 95% confidence interval for each of the feasibility measures to determine the range of estimates that are consistent with the data.
Percentage of Participants to Complete Exercise Sessions - Adherence 17 months Adherence will be measured by the percent of participants who complete at least 3 out 5 exercise sessions. Investigators will calculate 95% confidence interval for each of the feasibility measures to determine the range of estimates that are consistent with the data.
Number of Participants Who Complete Study Questionnaires - Retention At baseline and up to 17 months Retention will be defined as the number of participants who complete study questionnaires at baseline and one follow-up timepoint. Investigators will calculate 95% confidence interval for each of the feasibility measures to determine the range of estimates that are consistent with the data.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer Center🇺🇸Winston-Salem, North Carolina, United StatesPrincipal InvestigatorContactShirley Bluethmann, PhDPrincipal Investigator