Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers

Overview

A Randomized Clinical Trial examining the effects of Comprehensive Geriatric Assessment as an add on to oncologic treatment. Participants included are cancer patients found eligible for oncologic treatment, age 70 or more, and screened frail with the Geriatric 8 screening tool.

Full Title of Study: “Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers (PROGNOSIS-RCT)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: November 1, 2023

Detailed Description

This study aims to examine the effects of Comprehensive Geriatric Assessment and interventions on prognosis in the older frail cancer patient in a Randomized Clinical Trial design. Patients screened frail with the Geriatric 8 screening tool, aged 70 or more, and found eligible for oncologic treatment, will be included. We plan to enrol a total of 322 cancer patients for 12 months. Participants will be allocated randomly to either interventional or control group. Participants in the interventional group will be offered a Comprehensive Geriatric Assessment and intervention at the start-up of cancer treatment. The Comprehensive Geriatric Assessment will be an add on to standardized cancer treatment offered at the Oncologic Outpatient Clinic at Odense University Hospital. Comprehensive Geriatric Assessment will be performed by a team consisting of a doctor, nurse and physiotherapist. If needed, referral to a dietician or an occupational therapist for further evaluation will be made. The health issues are assessed using validated tests based on a Danish version of the Geriatric Core Dataset (G-CODE). Follow-up on Comprehensive Geriatric Assessment is scheduled for one month after initial evaluation. The randomized groups will be compared with respect to primary and secondary endpoints.

Interventions

  • Other: Comprehensive Geriatric Assessment and follow-up
    • All patients will receive standardized oncological treatment according to national guidelines. For patients randomized to the intervention arm, a full Comprehensive Geriatric Assessment (CGA) and corresponding interventions on identified health issues will be performed alongside oncologic treatment. The domains are assessed using validated tests based on a Danish version of the Geriatric Core Dataset (G-CODE). The domains are cognition, mood, comorbidity, functional status, physical status, polypharmacy, nutrition, fall risc and social support. The CGA will be performed by the PhD-student (geriatric resident) or a geriatrician together with geriatric nurses at the Department of Geriatric Medicine, OUH. Nutritional status and interventions are assessed by a dietician. A physical therapist will evaluate the physical performance as part of the CGA. Follow-up on initial treatment plan is scheduled to one month after baseline CGA.

Arms, Groups and Cohorts

  • Experimental: Intervention
    • Comprehensive Geriatric Assessment and follow-up as add on to standard oncologic care
  • No Intervention: Control
    • standard oncologic care according to national guidelines

Clinical Trial Outcome Measures

Primary Measures

  • physical function for patients receiving palliative oncologic treatment
    • Time Frame: 3 months
    • measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period.
  • unplanned hospital admissions for patients receiving adjuvant oncologic treatment
    • Time Frame: 6 months
    • number of unplanned hospitalisations including admissions to Oncologic Department, Emergency Department and Medical Departments. Data will be retrieved trough review of electronic medical records.

Secondary Measures

  • Physical functional for patients receiving curative oncologic treatment
    • Time Frame: 3 months
    • measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period.
  • Physical functional for patients receiving curative oncologic treatment
    • Time Frame: 6 months
    • measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period.
  • Physical functional for patients receiving palliative oncologic treatment
    • Time Frame: 6 months
    • measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period.
  • number of unplanned hospital admissions for patients receiving palliative oncologic treatment
    • Time Frame: 6 months
    • Number of unplanned hospitalisations including admissions to Oncologic Department, Emergency Department and Medical Departments. Data will be retrieved trough review of electronic medical records.
  • Health-related Quality of life
    • Time Frame: 12 months
    • Measured by EORTC-QLQ-C30
  • Health-related Quality of life
    • Time Frame: 12 months follow-up
    • Measured by EORTC-QLQ-ELD14
  • Elderly Functional Index Score (ELFI-score)
    • Time Frame: 6 months
    • Self reported functioning score. It is a composite score derived from the three scales “physical functioning”, “Role functioning” and Social Functioning”, from the quality of life questionnaire EORTC-QLQ-C30 and the scale “Mobility” from the quality of life questionnaire EORTC-QLQ-ELD-14. The range is (12-48), with a higher score being a better outcome.
  • Number of patients who experience oncologic treatment toxicity
    • Time Frame: 6 months
    • Treatment toxicity grade 3+ evaluated with Common Terminology Criteria for Adverse Events
  • Number of patients with adherence to initial oncologic treatment plan
    • Time Frame: 6 months
    • Registration of dose reductions, discontinuations and delays of intended cancer treatment.
  • Degree of Polypharmacy (PP)
    • Time Frame: 3 months
    • Degree of polypharmacy. Polypharmacy is defined as daily use of more than 5 prescription drugs.
  • Number of potential Inappropriate Medications (PIM)
    • Time Frame: 3 months
    • Using the Screening Tool for Older Persons Prescriptions (STOPP) criteria. Number of PIM will be registered for each patient
  • Number of Potential Drug Interactions (PDI)
    • Time Frame: 3 months
    • Using Stockley’s Drug Interaction Database. Number of PDI will be registered for each patient
  • Overall survival
    • Time Frame: 12 months
    • Measured from Geriatric 8 screening to time of death
  • Cancer specific survival
    • Time Frame: 12 months
    • Measured from Geriatric 8 screening to time of death in patients with residual cancer

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥ 70 years – Living in the region of Southern Denmark – Newly diagnosed solid tumours assessed eligible for antineoplastic treatment – Vulnerable or frail (G8 ≤ 14) Exclusion Criteria:

  • Inability to speak or understand Danish – Inability to give informed consent – Already consulting geriatric outpatient clinic – Already receiving active treatment for other coexisting solid tumours, haematologic cancers, or non-melanoma skin cancer or has received oncologic treatment the past year

Gender Eligibility: All

Minimum Age: 70 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Odense University Hospital
  • Collaborator
    • University of Southern Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ann-Kristine Weber Giger, Principal Investigator – Odense University Hospital
  • Overall Official(s)
    • Ann-Kristine W Giger, MD, Principal Investigator, Department of Geriatric Medicine, Odense University Hospital, Odense
    • Cecilia M Lund, MD, PhD, Study Chair, Department of Medicine, Herlev and Gentofte University Hospital, Copenhagen
    • Per Pfeiffer, MD, PhD, Study Chair, Department of Clinical Oncology, Odense University Hospital, Odense
    • Trine L Jørgensen, MD, PhD, Study Chair, Department of Clinical Oncology, Odense University Hospital, Odense
    • Marianne Ewertz, MD, DMSc, Study Chair, Institute of Clinical Research, University of Southern Denmark, Odense
    • Henrik Ditzel, MD, DMSc, Study Chair, Department og Geriatric Medicine, Odense University Hospital, Odense
    • Jesper Ryg, MD, PhD, Study Director, Department of Geriatric Medicine, Odense University Hospital
  • Overall Contact(s)
    • Jesper Ryg, MD, 60152610, Jesper.Ryg@rsyd.dk

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