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
Qualifiers
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 design
Treatments tested in this trial
- Practical Geriatric Assessment
- Correlation of body composition PGA and step count with outcomes
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Abramson Cancer Center at Penn Medicine
Lead sponsor
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov