The PAI Trial for Breast and Colon Cancer Survivors

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

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 Overview

• Status: Withdrawn
• Conditions: Breast Cancer; Colon Cancer
• Intervention / Treatment: Combination product: PAI Tool and Exercise Coaching

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants will receive standard follow-up survivorship care, an accelerometer to measure physical activity and NCCN (National Comprehensive Cancer Network) patient materials.
Experimental: Treatment; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Shirley M Bluethmann, PhD, Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2022
• Primary Completion (Actual): April 12, 2022
• Study Completion (Actual): April 12, 2022

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: November 30, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Geriatrics; Adult Cancer Survivors; Gerontology
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: STUDY00018917

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No