The PAI Trial for Breast and Colon Cancer Survivors

Not Applicable

Withdrawn

• Conditions: Breast Cancer; Colon Cancer
• Interventions: Combination Product: PAI Tool and Exercise Coaching

• Registration Number: NCT05156463
• Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-16
• Study First Submitted QC: 2021-11-30
• Study First Posted: 2021-12-14
• Status Verified: 2022-04
• Study Start: 2022-04-12
• Primary Completion: 2022-04-12
• Study Completion: 2022-04-12
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	PAI Tool and Exercise Coaching	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.

Primary Outcome Measures

Name	Time	Method
Use of Actigraph to measure changes in activity and sedentary behavior	7 days prior to each clinical visit (Baseline, 3 months, 6 months, 12 months)	Activity patterns and sedentary behavior based on 7 days of wear before clinical visit
Introduce PAI tool to increase PA and reduce sedentary behavior	7 days prior to each visit clinical visit (Baseline, 3 months, 6 months, 12 months)	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
Change in activity as measured by Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire for Older Adults	Baseline, 3 months, 6 months,12 months	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.

Secondary Outcome Measures

Name	Time	Method
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.	Baseline, 3 months, 6 months, 12 months	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).
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	Baseline, 3 months, 6 months,12 months	Aggregated assessment of self-reported information about demographic data, daily activities, nutritional status, medication use and health behaviors.