NCT06870617 Practical Geriatric Assessment (PGA) Implementation Strategies and Correlative Evaluations (PACE-70)
| NCT ID | NCT06870617 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abramson Cancer Center at Penn Medicine |
| Condition | Geriatric Assessment |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2025-07-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The use of a geriatric assessment to inform oncologic care for older persons with cancer is an evidence-based practice that improves patient-clinician communication, reduces treatment-related toxicity, and is recommended by national guidelines. However, the implementation of a geriatric assessment can be time-consuming and burdensome, leading to suboptimal use in clinical practice. Developed and endorsed by the American Society for Clinical Oncology (ASCO), the Practical Geriatric Assessment (PGA) is designed to improve clinical usability and adoption, but its implementation in real-world settings has not been evaluated. The PACE-70 study aims to evaluate PGA implementation and resultant chemotherapy dose modification among older adults with advanced cancer treated in a community setting. An exploratory aim will evaluate how the PGA, body composition (via abdominal computed tomography scan) and step count monitoring (via FitBit) correlate with chemotherapy toxicity and other clinical outcomes.
Eligibility 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
Contact & Investigator
Ramy Sedhom, M.D.
PRINCIPAL INVESTIGATOR
Penn Princeton
Frequently Asked Questions
Who can join the NCT06870617 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Geriatric Assessment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06870617 currently recruiting?
Yes, NCT06870617 is actively recruiting participants. Contact the research team at abigail.blaush@pennmedicine.upenn.edu for enrollment information.
Where is the NCT06870617 trial being conducted?
This trial is being conducted at Princeton, United States, Lancaster, United States, Philadelphia, United States.
Who is sponsoring the NCT06870617 clinical trial?
NCT06870617 is sponsored by Abramson Cancer Center at Penn Medicine. The principal investigator is Ramy Sedhom, M.D. at Penn Princeton. The trial plans to enroll 150 participants.