This clinical trial examines if using the Physical Activity Index (PAI) screener along with exercise coaching and self-monitoring tools (an activity tracker) will increase physical activity and reduce time spent being inactive (sedentary) in breast or colon cancer survivors who have recently undergone surgery, chemotherapy and/or radiation. Maintaining an active lifestyle is an integral part of clinical recommendations for cancer survivors, especially after completion of cancer treatment. However, survivors often do not meet recommended physical activity (PA) requirements following treatment. The PAI captures PA-related behaviors and scores them to provide an overall assessment of a patient's physical health and makes recommendations to decrease a sedentary lifestyle. Utilizing the PAI screener along with exercise coaching and self-monitoring tools may help patients stay more active after completion of cancer treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06340503.
PRIMARY OBJECTIVE:
I. 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.
EXPLORATORY OBJECTIVES:
I. Evaluate intervention acceptability by key stakeholders (clinical team and patients) as characterized by participant responses through quantitative and qualitative methods.
II. Collect physical activity outcomes and quantify outcome variability for moderate-to-vigorous intensity physical activity (MVPA) and sedentary behaviors.
OUTLINE: Patients are assigned to 1 of 2 arms, clinicians are assigned to arm 3.
Arm I (INTERVENTION): Patients receive standard care and complete PAI assessments at baseline, and again at 3-, 6-, 9- and 12-month visits on study. Patients also receive an exercise coaching call after baseline, and then booster calls before their 3-month visit, after their 3-month visit, before their 6-month visit and after their 6-month visit. Patients receive an accelerometer to be worn for 7 days at baseline and an activity tracker and National Comprehensive Cancer Network (NCCN) education materials on physical activity for survivorship on study.
Arm II (DELAYED EXERCISE): Patients receive standard care and complete PAI assessments at their 6 month visit, and again at their 9-month visit. Patients also receive an exercise coaching call after their 6-month visit, and the booster calls before their 9-month visit, after their 9-month visit, before their 12-month visit, and after their 12-month visit. Patients receive an accelerometer to be worn for 7 days at baseline and an activity tracker and NCCN education materials on physical activity for survivorship on study.
Arm III: Clinicians participate in focus group or interview on study.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorShirley Bluethmann
