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

NCT06870617 | Recruiting

• 1 other identifier: UPCC 19924
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Implementation of the PGA

  The proportion of eligible patients with a completed geriatric assessment within 14 days of initial oncology visit.

  14 days of initial oncology visit

Secondary Outcomes (1)

• Rates of dose modification

  Prior to cycle 1 of systemic chemotherapy.

Study Arms (2)

PGA Implementation Cohort (n=150)

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

Other: Practical Geriatric Assessment

Correlative analyses cohort (n=100)

Other: Practical Geriatric Assessment; Other: Correlation of body composition PGA and step count with outcomes

Interventions

Practical Geriatric Assessment OTHER

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); PGA Implementation Cohort (n=150)

Correlation of body composition PGA and step count with outcomes OTHER

Monitoring of step counts (measured via FitBit) and body composition (measured via standard abdominal CT scans)

Correlative analyses cohort (n=100)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may not qualify if:

• For Correlative Analysis Cohort, patients will be excluded if meeting any of the following criteria:
• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• Bristol-Myers Squibb: collaborator

Study Sites (3)

Penn Medicine Princeton Medical Center

Princeton, New Jersey, 08540, United States

RECRUITING

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

NOT YET RECRUITING

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (7)

• Dale W, Williams GR, R MacKenzie A, Soto-Perez-de-Celis E, Maggiore RJ, Merrill JK, Katta S, Smith KT, Klepin HD. How Is Geriatric Assessment Used in Clinical Practice for Older Adults With Cancer? A Survey of Cancer Providers by the American Society of Clinical Oncology. JCO Oncol Pract. 2021 Jun;17(6):336-344. doi: 10.1200/OP.20.00442. Epub 2020 Oct 15.

  PMID: 33064058 BACKGROUND

• Dale W, Klepin HD, Williams GR, Alibhai SMH, Bergerot C, Brintzenhofeszoc K, Hopkins JO, Jhawer MP, Katheria V, Loh KP, Lowenstein LM, McKoy JM, Noronha V, Phillips T, Rosko AE, Ruegg T, Schiaffino MK, Simmons JF Jr, Subbiah I, Tew WP, Webb TL, Whitehead M, Somerfield MR, Mohile SG. Practical Assessment and Management of Vulnerabilities in Older Patients Receiving Systemic Cancer Therapy: ASCO Guideline Update. J Clin Oncol. 2023 Sep 10;41(26):4293-4312. doi: 10.1200/JCO.23.00933. Epub 2023 Jul 17.

  PMID: 37459573 BACKGROUND

• Williams GR, Hopkins JO, Klepin HD, Lowenstein LM, Mackenzie A, Mohile SG, Somerfield MR, Dale W. Practical Assessment and Management of Vulnerabilities in Older Patients Receiving Systemic Cancer Therapy: ASCO Guideline Questions and Answers. JCO Oncol Pract. 2023 Sep;19(9):718-723. doi: 10.1200/OP.23.00263. Epub 2023 Jul 17. No abstract available.

  PMID: 37459585 BACKGROUND

• Green AK, Tabatabai SM, Aghajanian C, Landgren O, Riely GJ, Sabbatini P, Bach PB, Begg CB, Lipitz-Snyderman A, Mailankody S. Clinical Trial Participation Among Older Adult Medicare Fee-for-Service Beneficiaries With Cancer. JAMA Oncol. 2022 Dec 1;8(12):1786-1792. doi: 10.1001/jamaoncol.2022.5020.

  PMID: 36301585 BACKGROUND

• Mohile SG, Mohamed MR, Xu H, Culakova E, Loh KP, Magnuson A, Flannery MA, Obrecht S, Gilmore N, Ramsdale E, Dunne RF, Wildes T, Plumb S, Patil A, Wells M, Lowenstein L, Janelsins M, Mustian K, Hopkins JO, Berenberg J, Anthony N, Dale W. Evaluation of geriatric assessment and management on the toxic effects of cancer treatment (GAP70+): a cluster-randomised study. Lancet. 2021 Nov 20;398(10314):1894-1904. doi: 10.1016/S0140-6736(21)01789-X. Epub 2021 Nov 3.

  PMID: 34741815 BACKGROUND

• Versteeg KS, Konings IR, Lagaay AM, van de Loosdrecht AA, Verheul HMW. Prediction of treatment-related toxicity and outcome with geriatric assessment in elderly patients with solid malignancies treated with chemotherapy: a systematic review. Ann Oncol. 2014 Oct;25(10):1914-1918. doi: 10.1093/annonc/mdu052. Epub 2014 Feb 25.

  PMID: 24569912 BACKGROUND

• Garner WB, Smith BD, Ludmir EB, Wakefield DV, Shabason J, Williams GR, Martin MY, Wang Y, Ballo MT, VanderWalde NA. Predicting future cancer incidence by age, race, ethnicity, and sex. J Geriatr Oncol. 2023 Jan;14(1):101393. doi: 10.1016/j.jgo.2022.10.008. Epub 2022 Oct 28.

  PMID: 36692964 BACKGROUND

MeSH Terms

Interventions

Treatment Outcome

Intervention Hierarchy (Ancestors)

Prognosis; Diagnosis; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Evaluation Mechanisms; Health Care Quality, Access, and Evaluation

Study Officials

• Ramy Sedhom, M.D.

  Penn Princeton

  PRINCIPAL INVESTIGATOR

• Samuel Takvorian, M.D.

  Abramson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abigail Gottschalk, MPH

CONTACT

2156156825; abigail.blaush@pennmedicine.upenn.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 11, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-07

Locations

US (3)