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The PAI Trial for Breast and Colon Cancer Survivors

Primary Purpose

Breast Cancer, Colon Cancer

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

PAI Tool and Exercise Coaching

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Adult Cancer Survivors, Geriatrics, Gerontology

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Treatment

Arm Description

Participants will receive standard follow-up survivorship care, an accelerometer to measure physical activity and NCCN (National Comprehensive Cancer Network) patient materials.

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.

Outcomes

Primary Outcome Measures

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

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.

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

Secondary Outcome Measures

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.

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).

Full Information

NCT ID

NCT05156463

First Posted

November 16, 2021

Last Updated

April 20, 2022

Sponsor

Milton S. Hershey Medical Center

Collaborators

National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT05156463

Brief Title

The PAI Trial for Breast and Colon Cancer Survivors

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Award not yet received and PI is transferring to a different institution

Study Start Date

April 12, 2022 (Actual)

Primary Completion Date

April 12, 2022 (Actual)

Study Completion Date

April 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Milton S. Hershey Medical Center

Collaborators

National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Colon Cancer

Keywords

Adult Cancer Survivors, Geriatrics, Gerontology

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Participants will receive standard follow-up survivorship care, an accelerometer to measure physical activity and NCCN (National Comprehensive Cancer Network) patient materials.

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Intervention Type

Combination Product

Intervention Name(s)

PAI Tool and Exercise Coaching

Intervention Description

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.

Primary Outcome Measure Information:

Title

Introduce PAI tool to increase PA and reduce sedentary behavior

Description

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)

Title

Change in activity as measured by Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire for Older Adults

Description

Time Frame

Baseline, 3 months, 6 months,12 months

Title

Use of Actigraph to measure changes in activity and sedentary behavior

Description

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 Outcome Measure Information:

Title

Description

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

Title

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.

Description

Time Frame

Baseline, 3 months, 6 months, 12 months

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

Female breast cancer survivors Female/Male colon cancer survivors

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shirley M Bluethmann, PhD

Organizational Affiliation

Milton S. Hershey Medical Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The PAI Trial for Breast and Colon Cancer Survivors

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