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

Not Applicable

Recruiting

• Conditions: Breast Cancer; Colon Cancer
• Interventions: Device: Research-grade accelerometer; Other: National Comprehensive Cancer Network (NCCN) Education Materials; Device: Garmin Vivofit activity tracker; Other: Exercise Consultation Calls; Other: Interview; Other: Physical Activity Index Assessment (Control Arm); Other: Physical Activity Index Assessment (Intervention Arm); Other: Health Surveys

• 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.

Study Timeline

• Study First Submitted: 2024-03-25
• Study First Submitted QC: 2024-03-25
• Study First Posted: 2024-04-01
• Study Start: 2024-11-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Intervention Arm	Research-grade accelerometer	Participants randomized into the intervention arm will receive a pre-exercise screening call about two weeks after enrolling into the study and complete the six (6) study visits and pre-determined test and procedures for the patient intervention arm.
Patient Intervention Arm	National Comprehensive Cancer Network (NCCN) Education Materials	Participants randomized into the intervention arm will receive a pre-exercise screening call about two weeks after enrolling into the study and complete the six (6) study visits and pre-determined test and procedures for the patient intervention arm.
Patient Intervention Arm	Garmin Vivofit activity tracker	Participants randomized into the intervention arm will receive a pre-exercise screening call about two weeks after enrolling into the study and complete the six (6) study visits and pre-determined test and procedures for the patient intervention arm.
Patient Intervention Arm	Health Surveys	Participants randomized into the intervention arm will receive a pre-exercise screening call about two weeks after enrolling into the study and complete the six (6) study visits and pre-determined test and procedures for the patient intervention arm.
Waitlist Control Arm	Research-grade accelerometer	Participants randomized to the waitlist control arm, will have vitals collected and complete surveys at the first (baseline), 3-month, and 6-month visits pre-determined test and procedures for the waitlist control arm. The pre-exercise consultation will begin after the 6-month visit.
Patient Intervention Arm	Exercise Consultation Calls	Participants randomized into the intervention arm will receive a pre-exercise screening call about two weeks after enrolling into the study and complete the six (6) study visits and pre-determined test and procedures for the patient intervention arm.
Patient Intervention Arm	Interview	Participants randomized into the intervention arm will receive a pre-exercise screening call about two weeks after enrolling into the study and complete the six (6) study visits and pre-determined test and procedures for the patient intervention arm.
Patient Intervention Arm	Physical Activity Index Assessment (Intervention Arm)	Participants randomized into the intervention arm will receive a pre-exercise screening call about two weeks after enrolling into the study and complete the six (6) study visits and pre-determined test and procedures for the patient intervention arm.
Waitlist Control Arm	Health Surveys	Participants randomized to the waitlist control arm, will have vitals collected and complete surveys at the first (baseline), 3-month, and 6-month visits pre-determined test and procedures for the waitlist control arm. The pre-exercise consultation will begin after the 6-month visit.
Waitlist Control Arm	National Comprehensive Cancer Network (NCCN) Education Materials	Participants randomized to the waitlist control arm, will have vitals collected and complete surveys at the first (baseline), 3-month, and 6-month visits pre-determined test and procedures for the waitlist control arm. The pre-exercise consultation will begin after the 6-month visit.
Waitlist Control Arm	Garmin Vivofit activity tracker	Participants randomized to the waitlist control arm, will have vitals collected and complete surveys at the first (baseline), 3-month, and 6-month visits pre-determined test and procedures for the waitlist control arm. The pre-exercise consultation will begin after the 6-month visit.
Waitlist Control Arm	Interview	Participants randomized to the waitlist control arm, will have vitals collected and complete surveys at the first (baseline), 3-month, and 6-month visits pre-determined test and procedures for the waitlist control arm. The pre-exercise consultation will begin after the 6-month visit.
Waitlist Control Arm	Physical Activity Index Assessment (Control Arm)	Participants randomized to the waitlist control arm, will have vitals collected and complete surveys at the first (baseline), 3-month, and 6-month visits pre-determined test and procedures for the waitlist control arm. The pre-exercise consultation will begin after the 6-month visit.

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.

Trial Locations

Locations (1)

Atrium Health Wake Forest Baptist Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States