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

Cancer Clinical Trial

— PROGNOSIS-RCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04686851
• Other study ID #: PROGNOSIS-RCT
• Secondary ID: R247-A1438220/ 1
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: June 1, 2024

Study information

• Verified date: December 2023
• Source: Odense University Hospital
• Contact: Jesper Ryg, MD
• Phone: 60152610
• Email: Jesper.Ryg[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 322
• Est. completion date: June 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age
• Cancer
• Frailty

Intervention

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.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense	Southern Denmark

Sponsors (6)

Lead Sponsor	Collaborator
Odense University Hospital	Academy of Geriatric Cancer, Danish Cancer Society, Odense Patient Data Explorative Network, Region of Southern Denmark, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Health-related Quality of life	Measured by EORTC-QLQ-C30	12 months
Secondary	Health-related Quality of life	Measured by EORTC-QLQ-ELD14	12 months follow-up
Secondary	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
Secondary	Number of patients who experience oncologic treatment toxicity	Treatment toxicity grade 3+ evaluated with Common Terminology Criteria for Adverse Events	6 months
Secondary	Number of patients with adherence to initial oncologic treatment plan	Registration of dose reductions, discontinuations and delays of intended cancer treatment.	6 months
Secondary	Degree of Polypharmacy (PP)	Degree of polypharmacy. Polypharmacy is defined as daily use of more than 5 prescription drugs.	3 months
Secondary	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
Secondary	Number of Potential Drug Interactions (PDI)	Using Stockley's Drug Interaction Database. Number of PDI will be registered for each patient	3 months
Secondary	Overall survival	Measured from Geriatric 8 screening to time of death	12 months
Secondary	Cancer specific survival	Measured from Geriatric 8 screening to time of death in patients with residual cancer	12 months