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

Not Applicable

Recruiting

• Conditions: Frailty; Cancer; Age
• Interventions: Other: Comprehensive Geriatric Assessment and follow-up

• Registration Number: NCT04686851
• Lead Sponsor: Odense University Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-10-26
• Study Start: 2020-11-01
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-29
• Primary Completion: 2023-11-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-13
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 322

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Comprehensive Geriatric Assessment and follow-up	Comprehensive Geriatric Assessment and follow-up as add on to standard oncologic care

Primary Outcome Measures

Name	Time	Method
physical function for patients receiving palliative oncologic treatment	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	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 Outcome Measures

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

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Southern Denmark, Denmark