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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06340503
• Other study ID #: IRB00111331
• Secondary ID: WFBCCC 01123P30C
• Status: Recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: August 2025

Study information

• Verified date: June 2024
• Source: Wake Forest University Health Sciences
• Contact: Principal Investigator
• Phone: 336-716-3324
• Email: sbluethm[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer
• Colonic Neoplasms

Intervention

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
• 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
• 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
• 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.
• Health Surveys
Various health surveys will be completed to assess participant health and physical activities.

Locations

Country	Name	City	State
United States	Atrium Health Wake Forest Baptist Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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