Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers (PROGNOSIS-RCT)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Frailty
- Sponsor
- Odense University Hospital
- Enrollment
- 322
- Locations
- 1
- Primary Endpoint
- physical function for patients receiving palliative oncologic treatment
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Ann-Kristine Weber Giger
Principal Investigator
Odense University Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
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 Outcomes
- Number of patients with adherence to initial oncologic treatment plan(6 months)
- Physical functional for patients receiving curative oncologic treatment(6 months)
- Health-related Quality of life(12 months follow-up)
- Elderly Functional Index Score (ELFI-score)(6 months)
- Cancer specific survival(12 months)
- Overall survival(12 months)
- Physical functional for patients receiving palliative oncologic treatment(6 months)
- number of unplanned hospital admissions for patients receiving palliative oncologic treatment(6 months)
- Number of patients who experience oncologic treatment toxicity(6 months)
- Degree of Polypharmacy (PP)(3 months)
- Number of potential Inappropriate Medications (PIM)(3 months)
- Number of Potential Drug Interactions (PDI)(3 months)