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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Colon Cancer
• Intervention / Treatment: 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 (Intervention Arm); Other: Health Surveys; Other: Physical Activity Index Assessment (Control Arm)

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Principal Investigator; Phone Number: 336-716-3324; Email: sbluethm@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist Comprehensive Cancer Center
      • Contact: Principal Investigator
      • Principal Investigator: Shirley Bluethmann, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 be to sign an IRB-approved informed consent document directly.
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient 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.	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: Health Surveys; Various health surveys will be completed to assess participant health and physical activities.
Active Comparator: Waitlist 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.	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: 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: Health Surveys; Various health surveys will be completed to assess participant health and physical activities.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Eligible Participants - Participation Rate	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.	12 months
Percentage of Participants to Complete Exercise Sessions - Adherence	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.	12 months
Number of Participants Who Complete Study Questionnaires - Retention	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.	At baseline and up to 12 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Physical activity; Exercise coaching
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: IRB00111331; P30CA012197 (U.S. NIH Grant/Contract); WFBCCC 01123 (Other Identifier: Atrium Health Wake Forest Baptist Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No