Practical Geriatric Assessment (PGA) Implementation Strategies and Correlative Evaluations (PACE-70)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age70+
SponsorAbramson Cancer Center at Penn Medicine
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age greater than or equal to 70 years.
Diagnosis of advanced or metastatic solid malignancy
Initiating a new line of palliative-intent systemic therapy with a prevalence of grade 3 toxicity exceeding 50%.
Must read and speak English and be able to fill out surveys
Disqualifiers
Unable to effectively read and speak English
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)
Concurrent enrollment in a therapeutic clinical trial (as clinical trials often have a substantial symptom-reporting structure). Non-therapeutic clinical trial enrollment is permitted
Lack of clinician consent to approach patient
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Practical Geriatric Assessment
Other interventionThe 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
Other interventionMonitoring of step counts (measured via FitBit) and body composition (measured via standard abdominal CT scans)
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: PGA Implementation Cohort (n=150)1 intervention
Group B: Correlative analyses cohort (n=100)2 interventions
Trial outcomes
Primary outcomes
1
Implementation of the PGA
The proportion of eligible patients with a completed geriatric assessment within 14 days of initial oncology visit.
Time frame
14 days of initial oncology visitSecondary outcomes
1
Rates of dose modification
The proportion of patients with geriatric impairment whose initial cycle of systemic therapy is dose modified.
Time frame
Prior to cycle 1 of systemic chemotherapy.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Abramson Cancer Center at Penn Medicine
Lead sponsor
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov