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

October 2, 2025 updated by: Abramson Cancer Center at Penn Medicine

Practical Geriatric Assessment (PGA) Implementation Strategies and Correlative Evaluations for Older Adults With Cancer (PACE-70): A Hybrid Implementation-effectiveness Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • Princeton, New Jersey, United States, 08540
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17602
      • Philadelphia, Pennsylvania, United States, 19107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PGA Implementation Cohort (n=150)
All eligible patients will be evaluated on their completion rates of the practical geriatric assessment.
Other: Practical Geriatric Assessment
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.
Correlative analyses cohort (n=100)
Other: Practical Geriatric Assessment
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.
Other: Correlation of body composition PGA and step count with outcomes
Monitoring of step counts (measured via FitBit) and body composition (measured via standard abdominal CT scans)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implementation of the PGA
Time Frame: 14 days of initial oncology visit
The proportion of eligible patients with a completed geriatric assessment within 14 days of initial oncology visit.
14 days of initial oncology visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of dose modification
Time Frame: Prior to cycle 1 of systemic chemotherapy.
The proportion of patients with geriatric impairment whose initial cycle of systemic therapy is dose modified.
Prior to cycle 1 of systemic chemotherapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Ramy Sedhom, M.D., Penn Princeton
  • Principal Investigator: Samuel Takvorian, M.D., Abramson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

October 2, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 19924

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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