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Clinical Trials/NCT06340503
NCT06340503
Active, not recruiting
Not Applicable

Evaluating a Physical Activity Index for Assessment and Counseling for Breast and Colon Cancer Survivors in Clinical Practice

Wake Forest University Health Sciences1 site in 1 country20 target enrollmentNovember 6, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Wake Forest University Health Sciences
Enrollment
20
Locations
1
Primary Endpoint
Number of Eligible Participants - Participation Rate
Status
Active, not recruiting
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 6, 2024
End Date
June 1, 2026
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Number of Eligible Participants - Participation Rate

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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