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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)

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05156463
Enrollment
0
Registered
2021-12-14
Start date
2022-04-12
Completion date
2022-04-12
Last updated
2022-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Colon Cancer

Keywords

Adult Cancer Survivors, Geriatrics, Gerontology

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.

Interventions

COMBINATION_PRODUCTPAI 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.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Milton S. Hershey Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Introduce PAI tool to increase PA and reduce sedentary behavior7 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 AdultsBaseline, 3 months, 6 months,12 monthsThis 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 behavior7 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

Secondary

MeasureTime frameDescription
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 QuestionnaireBaseline, 3 months, 6 months,12 monthsAggregated 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.Baseline, 3 months, 6 months, 12 monthsFor 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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026