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Completed

NCT Number: NCT06340503

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

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.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Research-grade accelerometer

Device

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.

National Comprehensive Cancer Network (NCCN) Education Materials

Other

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.

Garmin Vivofit activity tracker

Device

This device can automatically capture and classify different physical activities such as walking, running, biking, swimming and using an elliptical.

Exercise Consultation Calls

Other

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

Other

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)

Other

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)

Other

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

Other

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

Primary outcomes

  1. Number of Eligible Participants - Participation Rate

    Time frame: 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.

  2. Percentage of Participants to Complete Exercise Sessions - Adherence

    Time frame: 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.

  3. Number of Participants Who Complete Study Questionnaires - Retention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2024
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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