Practical Geriatric Assessment (PGA) Implementation Strategies and Correlative Evaluations (PACE-70)

Not yet recruiting

• Conditions: Geriatric Assessment; Advanced Cancer; Toxicity

• Registration Number: NCT06870617
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Advancing age is the most significant risk factor for cancer. By 2040, it is projected that 60 percent of newly diagnosed cancer cases will occur in individuals aged 70 years or older.5 Managing cancer in older adults requires careful evaluation of treatment risks and benefits, as over 70 percent of older patients experience grade 3+ adverse events, which can impact quality of life and necessitate therapy modifications.6 Moreover, adults over 75 years represent less than 2 percent of participants in phase 3 oncology trials despite constituting 20 percent of incident cancer diagnoses. Consequently, the results of these trials which often lead to drug approvals may not generalize to older adult populations, particularly with respect to drug safety and effectiveness.7,8 There is critical need to generate knowledge regarding best practices for oncologic care tailored to older adult populations.

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. The American Society of Clinical Oncology (ASCO) recommends the use of a geriatric assessment (GA) for all adults older than 65 years, and GA-guided management among those with identified impairment. GA-guided management strategies include using GA results to inform cancer treatment decision-making (ie, with respect to treatment selection and/or dose modification) and to address impairments through appropriate interventions, counseling, and referrals.9,10

Despite these recommendations, geriatric assessment is infrequently used in routine practice. Studies have shown that the majority (80 percent) of oncologists do not use a formal geriatric assessment to inform treatment decisions for their older patients. Developed by ASCO, the Practical Geriatric Assessment (PGA) is a novel, validated, pragmatic method of geriatric assessment that relies heavily on patient and caregiver-reported information. It was developed in response to the perception of the comprehensive geriatric assessment as "too cumbersome to incorporate into routine practice" (44%) or "adding no value" (36%). 11 While PGA holds promise for increasing adoption of geriatric assessment in routine oncology care, its feasibility and real-world implementation remain poorly understood, particularly in community oncology settings where most older adults receive care.

The PACE-70 study aims to evaluate novel implementation strategies for the PGA in routine clinical practice for older adults with cancer treated in a community setting. The primary objective is to assess rates of PGA completion. The secondary objective is to evaluate how PGA findings influence dose modification of anti-cancer therapy. Additionally, this trial will explore associations between PGA findings, body composition, and step count monitoring with chemotherapy toxicity and other clinical outcomes. This exploratory aim seeks to determine whether integrating digital technologies with PGA can better predict vulnerability and guide personalized care in older adults with cancer.

The PACE-70 study is a Type III hybrid implementation-effectiveness study enrolling at three community sites within a large academic health system. Eligible participants will be 70 years or older, have a diagnosis of advanced or metastatic solid malignancy, and be starting a new line of palliative-intent systemic therapy, where the expected prevalence of grade 3 toxicity exceeds 50 percent. The PGA will be administered via the electronic health record (EHR), available for patients to complete independently prior to an initial medical oncology visit, or during the visit with staff assistance. Results from the PGA will be shared automatically with clinical teams via the EHR, including a Best Practice Alert highlighting any identified geriatric impairment(s) and ASCO's recommendation for PGA-adapted care. The primary outcome will be the PGA completion rate. The secondary outcome will be the rate of chemotherapy dose modification among those with any identified geriatric impairment. Clinician perspectives on PGA implementation will be assessed via structured interviews among a sub-sample of participating clinicians. In a subsample of patients consenting to additional data collection, exploratory analyses will examine correlations between the PGA, step counts (measured via FitBit) and body composition (measured via standard abdominal CT scans) with clinical outcomes, including toxicity, hospitalization, and death.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Study First Posted: 2025-03-11
• Last Update Posted: 2025-03-11
• Study Start: 2025-04-01
• Primary Completion: 2026-04-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implementation of the PGA	14 days of initial oncology visit	The proportion of eligible patients with a completed geriatric assessment within 14 days of initial oncology visit.

Secondary Outcome Measures

Name	Time	Method
Rates of dose modification	Prior to cycle 1 of systemic chemotherapy.	The proportion of patients with geriatric impairment whose initial cycle of systemic therapy is dose modified.

Trial Locations

Locations (3)

Penn Medicine Princeton Medical Center; 🇺🇸 Princeton, New Jersey, United States

Lancaster General Hospital; 🇺🇸 Lancaster, Pennsylvania, United States

Pennsylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States