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

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.

Conditions

• Breast Cancer
• Colon Cancer

Interventions

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• Shirley Bluethmann · Wake Forest Baptist Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-06

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• United States

Study Locations