Practical Geriatric Assessment (PGA) implementation and correlative evaluations (PACE-70)
Practical Geriatric Assessment (PGA) Implementation Strategies and Correlative Evaluations for Older Adults With Cancer (PACE-70): A Hybrid Implementation-effectiveness Study
This project will test whether using the Practical Geriatric Assessment (PGA) in community cancer clinics can guide chemotherapy dosing and whether body composition and step counts relate to treatment toxicity in adults aged 70 and older with advanced cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Princeton, New Jersey and 2 other locations) |
| Trial ID | NCT06870617 on ClinicalTrials.gov |
What this trial studies
PACE-70 implements the Practical Geriatric Assessment (PGA) in community oncology clinics to observe how often PGA findings lead to chemotherapy dose modifications and to measure treatment-related toxicities in adults aged 70 and older with advanced solid tumors. The observational implementation cohort at three Penn Medicine-affiliated sites will record PGA uptake, clinician actions, and rates of grade 3+ adverse events. A correlative cohort will collect abdominal CT-based body composition metrics, continuous step counts via Fitbit, and patient-reported surveys to see how those measures relate to toxicity and functional outcomes. Study data will be analyzed to link PGA results, biological and activity measures, and chemotherapy dosing changes to real-world toxicity and care patterns.
Who should consider this trial
Good fit: Ideal candidates are adults aged 70 or older with advanced or metastatic solid tumors starting a new palliative systemic therapy, with correlative-cohort participants additionally able to read English, walk independently or with an assistive device, own a compatible smartphone, and consent to Fitbit monitoring and CT-based body composition analysis.
Not a fit: Patients younger than 70, those with early-stage disease not starting palliative systemic therapy, or individuals unable to read English or use a smartphone are generally not eligible and therefore unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this could make geriatric assessment practical for community oncologists and help reduce severe chemotherapy toxicity through better-informed dosing decisions.
How similar studies have performed: Prior trials and guideline-driven research show geriatric assessments can improve communication and reduce toxicity, but implementing the PGA in real-world community clinics and linking it to body composition and step counts is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
For PGA Implementation Cohort, patients must meet the following criteria: 1. Age greater than or equal to 70 years. 2. Diagnosis of advanced or metastatic solid malignancy 3. Initiating a new line of palliative-intent systemic therapy with a prevalence of grade 3 toxicity exceeding 50%. For Correlative Analysis Cohort, patients must additionally meet the following criteria: 1. Must read and speak English and be able to fill out surveys 2. Ability to walk independently or with the use of an assistive device (e.g., walker, cane) 3. Consents to participate in correlative analysis cohort with Fitbit monitoring, body composition analysis, and self-report surveys 4. Have a smartphone able to operate with the Fitbit For PGA Implementation Cohort, there are no specific exclusion criteria other than not meeting inclusion criteria. For Correlative Analysis Cohort, patients will be excluded if meeting any of the following criteria: 1. Unable to effectively read and speak English 2. Reliance on a wheelchair, ECOG of 3 or above, clinically bedbound, or unable to walk without assistance every day for the past 7 days (ECOG 3 is confined to bed or chair for more than 50% of waking hours) 3. Concurrent enrollment in a therapeutic clinical trial (as clinical trials often have a substantial symptom-reporting structure). Non-therapeutic clinical trial enrollment is permitted 4. Lack of clinician consent to approach patient
Where this trial is running
Princeton, New Jersey and 2 other locations
- Penn Medicine Princeton Medical Center — Princeton, New Jersey, United States (Recruiting)
- Lancaster General Hospital — Lancaster, Pennsylvania, United States (Not_yet_recruiting)
- Pennsylvania Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Ramy Sedhom, M.D. — Penn Princeton
- Study coordinator: Abigail Gottschalk, MPH
- Email: abigail.blaush@pennmedicine.upenn.edu
- Phone: 2156156825
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.