Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Award not yet received and PI is transferring to a different institution
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PAI Tool and Exercise Coaching | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- Participants will receive standard follow-up survivorship care, an accelerometer to measure physical activity and NCCN (National Comprehensive Cancer Network) patient materials.
- type
- EXPERIMENTAL
- label
- Treatment
- description
- 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.
- interventionNames
- Combination Product: PAI Tool and Exercise Coaching
Primary outcomes (3)
- measure
- Introduce PAI tool to increase PA and reduce sedentary behavior
- timeFrame
- 7 days prior to each visit clinical visit (Baseline, 3 months, 6 months, 12 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available