The PAI Trial for Breast and Colon Cancer Survivors

Study Overview
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Brief Summary
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The purpose of the study is to determine if a Physical Activity Index (PAI) tool that collects measures on physical activity, strength training and sedentary behavior can be used in a clinical setting to monitor patient behavior and provide specific recommendations on how to achieve and maintain behavior goals. The tool will be used after treatment is completed in breast and colon cancer survivors and will test if physician counseling combined with patient self-monitoring improves physical activity and reduces sedentary behavior over time.

Official Title
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Evaluating a Physical Activity Assessment and Counseling Index for Breast and Colon Cancer Survivors in Clinical Practice (The PAI Trial)

Conditions
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Breast Cancer, Colon Cancer

Intervention / Treatment
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* Combination Product: PAI Tool and Exercise Coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women ages 60 years or older diagnosed with breast cancer and women or men ages 60 years or older diagnosed with colon cancer within the last 5 years ≥ 3 months post-completion of last prescribed treatment (i.e., Chemotherapy, radiation therapy or surgery) Stages I-III (no stage 0 or metastatic cases will be included) Able to understand spoken and written instructions in English Participate in 60 minutes or more of MVPA (moderate to vigorous-intensity physical activity)/week for previous 6 months Have internet access or access to data sharing plan Willing to come to four Penn State Health visits over the course of a year, completing requested questionnaires Willing to use Garmin Vivofit device, participate in exercise coaching sessions and complete exercise logs between visits Exclusion Criteria: Prior respiratory, joint or cardiovascular problems precluding PA Metastatic disease Planned elective surgery during intervention/follow-up Exhibit gross cognitive impairment We will not include any of the following vulnerable populations: adults unable to consent, individuals who are not yet adults, pregnant women, neonates, or prisoners.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants will receive standard follow-up survivorship care, an accelerometer to measure physical activity and NCCN (National Comprehensive Cancer Network) patient materials. | |
| Experimental: Treatment<br>Participants will receive same materials as standard of care group. In addition participants will use PAI Activity tool, Garmin activity tracker and exercise logs, and also receive periodic exercise coaching. | Combination Product: PAI Tool and Exercise Coaching<br>* Use of PAI tool and self-monitoring tools to increase physical activity and reduce sedentary behaviors. Participants will receive a personalized physical assessment and counseling from healthcare provider, exercise logs and a Garmin activity tracker to use between visits and 9 exercise coaching calls between clinical visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Introduce PAI tool to increase PA and reduce sedentary behavior | PAI Tool: frequency and time spent in strenuous moderate and mild PA over 7 days and self reported television time or sedentary screen time per week | 7 days prior to each visit clinical visit (Baseline, 3 months, 6 months, 12 months) | 
| Change in activity as measured by Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire for Older Adults | This self-report questionnaire assesses weekly frequency and duration of a variety of lifestyle physical activities that are meaningful and appropriate for older adults. Scores are recorded based on number of repetitions the activity was completed and the hours spent doing the activity from less than 1 hour to 9 or more hours. | Baseline, 3 months, 6 months,12 months | 
| Use of Actigraph to measure changes in activity and sedentary behavior | Activity patterns and sedentary behavior based on 7 days of wear before clinical visit | 7 days prior to each clinical visit (Baseline, 3 months, 6 months, 12 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Cancer and Aging Research Group (CARG) plus National Health and Nutrition Examination Survey (NHANES) and Patient-Reported Outcomes Measurement Information System (PROMIS) Geriatric Assessment Study Patient Questionnaire | Aggregated assessment of self-reported information about demographic data, daily activities, nutritional status, medication use and health behaviors. | Baseline, 3 months, 6 months,12 months | 
| Exercise Self-Efficacy Scale This scale assesses an individual's beliefs in their ability to continue exercising on a 3 time/week basis at moderate intensities for 40+ min. per session in the future. | For 8 items, participants indicate their confidence to execute the behavior on a 100-pt percentage scale comprised of 10-pt increments, ranging from 0% (not at all confident) to 100% (highly confident). | Baseline, 3 months, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult Cancer Survivors, Geriatrics, Gerontology