Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers (PROGNOSIS-RCT)

Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers (PROGNOSIS-RCT)

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Frailty; Age
• Intervention / Treatment: Other: Comprehensive Geriatric Assessment and follow-up

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.

• Study Type: Interventional
• Enrollment (Estimated): 322
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jesper Ryg, MD; Phone Number: 0045 60152610; Email: Jesper.Ryg@rsyd.dk

Study Locations

• Denmark
  • Southern Denmark
    • Odense, Southern Denmark, Denmark, 5000
      • Recruiting
      • Odense University Hospital
      • Contact: Jesper Ryg, MD, Prof.; Phone Number: 0045 60152610; Email: jesper.ryg@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Comprehensive Geriatric Assessment and follow-up as add on to standard oncologic care	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.
No Intervention: Control; standard oncologic care according to national guidelines

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: Danish Cancer Society; University of Southern Denmark; Region of Southern Denmark; Odense Patient Data Explorative Network; Academy of Geriatric Cancer
• Investigators: Principal Investigator: Ann-Kristine W Giger, MD, Department of Geriatric Medicine, Odense University Hospital, Odense; Study Chair: Cecilia M Lund, MD, PhD, Department of Medicine, Herlev and Gentofte University Hospital, Copenhagen; Study Chair: Per Pfeiffer, MD, PhD, Department of Clinical Oncology, Odense University Hospital, Odense; Study Chair: Trine L Jørgensen, MD, PhD, Department of Clinical Oncology, Odense University Hospital, Odense; Study Chair: Marianne Ewertz, MD, DMSc, Institute of Clinical Research, University of Southern Denmark, Odense; Study Chair: Henrik Ditzel, MD, DMSc, Department og Geriatric Medicine, Odense University Hospital, Odense; Study Director: Jesper Ryg, MD, PhD, Department of Geriatric Medicine, Odense University Hospital

Publications and helpful links

General Publications

• Giger AW, Ditzel HM, Jorgensen TL, Ditzel HJ, Mohammadnejad A, Ewertz M, Pfeiffer P, Lund CM, Ryg J. Predictive value of geriatric oncology screening and geriatric assessment of older patients with cancer: A randomized clinical trial protocol (PROGNOSIS-RCT). J Geriatr Oncol. 2022 Jan;13(1):116-123. doi: 10.1016/j.jgo.2021.07.005. Epub 2021 Aug 4.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): November 1, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Neoplasms; Cancer Patients; Frailty; Aged; Randomized Clinical Trial; Geriatric Assessment; Geriatric 8; Geriatric Screening
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: PROGNOSIS-RCT; R247-A14382 (Other Grant/Funding Number: Danish Cancer Society); 20/ 17768 (Other Identifier: Region of Southern Denmark)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No