Recruiting

PGA Implementation

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT06870617

Conditions

Geriatric Assessment

Advanced Cancer

Toxicity

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Interventions

Practical Geriatric Assessment

Correlation of body composition PGA and step count with outcomes

Study Details

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.

Conditions

Geriatric Assessment

Advanced Cancer

Toxicity

Study ID

NCT06870617

Start date

Jul 1, 2025

Status verified date

Aug, 2026

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

PGA Implementation Cohort (n=150)

All eligible patients will be evaluated on their completion rates of the practical geriatric assessment.

Correlative analyses cohort (n=100)

Interventions

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.

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)

Primary outcome measure

  • Implementation of the PGA [ Time Frame: 14 days of initial oncology visit ]

Central Contacts and Locations

Central contacts

Locations

Penn Medicine Princeton Medical Center

Recruiting

Princeton, New Jersey, United States, 08540

Contacts

Pennsylvania Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • PACE-70
  • Practical geriatric assessment
  • body composition in cancer
  • step count in cancer
  • Start low go slow

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-08-06.