The PAI Trial for Breast and Colon Cancer Survivors
April 20, 2022 updated by: Shirley Bluethmann, Milton S. Hershey Medical Center
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Withdrawn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
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
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.
|
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
Time Frame: 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
|
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
Time Frame: 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.
|
Baseline, 3 months, 6 months,12 months
|
|
Use of Actigraph to measure changes in activity and sedentary behavior
Time Frame: 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
|
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
Time Frame: 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.
|
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.
Time Frame: 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).
|
Baseline, 3 months, 6 months, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Shirley M Bluethmann, PhD, Milton S. Hershey Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.