The PAI Trial for Breast and Colon Cancer Survivors

Milton S. Hershey Medical Center

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Conditions

Breast Cancer Colon Cancer

Interventions

PAI Tool and Exercise CoachingCOMBINATION_PRODUCT

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.

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 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

Time frame: 7 days prior to each clinical visit (Baseline, 3 months, 6 months, 12 months)

Secondary Outcomes

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.

Time frame: 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).

Data from ClinicalTrials.gov

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