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

Odense University Hospital

Status

Enrolling

Conditions

Age

Cancer

Frailty

Treatments

Other: Comprehensive Geriatric Assessment and follow-up

Study type

Interventional

Funder types

Other

Identifiers

NCT04686851

20/ 17768 (Other Identifier)

R247-A14382 (Other Grant/Funding Number)

PROGNOSIS-RCT

Details and patient eligibility

About

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 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.

Enrollment

322 estimated patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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