NCT06340503

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Colon Cancer

Interventions

Type	Name	Description
DEVICE	Research-grade accelerometer	Participants will be instructed to wear device for 7 days prior to each visit and to bring the device to each visit. Study staff will extract data from the device within 14 days after each appointment and return the device to patients by mail.
OTHER	National Comprehensive Cancer Network (NCCN) Education Materials	The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) are comprised of recommendations for the prevention, diagnosis, and management of malignancies across the continuum of care.
DEVICE	Garmin Vivofit activity tracker	This device can automatically capture and classify different physical activities such as walking, running, biking, swimming and using an elliptical.
OTHER	Exercise Consultation Calls	The intervention group will receive five monthly exercise consultation calls with an exercise coach in between clinical visits and be provided with an exercise log for their personal use
OTHER	Interview	The interviews will be conducted by a trained Q-PRO interviewer and audio recorded. Interviews are expected to last approximately 30 minutes. Discussion will include acceptability of the PAI intervention, related tools, and clinical experiences and will help shape/inform refinements need for a larger efficacy trial
OTHER	Physical Activity Index Assessment (Intervention Arm)	Assessment will capture frequency and time spent in strenuous, moderate, and mild PA over the past 7 days. Survivors also report hours of TV or similar sedentary screen time per week as a measure of sedentary behavior. Completed at months 1, 3, 6, 9 and 12 while on study
OTHER	Physical Activity Index Assessment (Control Arm)	Assessment will capture frequency and time spent in strenuous, moderate, and mild PA over the past 7 days. Survivors also report hours of TV or similar sedentary screen time per week as a measure of sedentary behavior. Completed at months 6, 9 and 12 while on study.
OTHER	Health Surveys	Various health surveys will be completed to assess participant health and physical activities.

Timeline

• Start date: 2024-11-06
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-04-01
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States