An interventional study of Comprehensive Geriatric Assessment and follow-up in Frailty, Cancer and Age, sponsored by Odense University Hospital. Recruiting at 1 site in Denmark. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by Odense University Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,199 studies on the registry are indexed under Frailty; 430 are open to participants now.
This study's planned enrollment of 322 is above the median of 80 across 681 interventional studies indexed under Frailty.
Browse Frailty studies →Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Comprehensive Geriatric Assessment and follow-up as add on to standard oncologic care
Other: Comprehensive Geriatric Assessment and follow-up
standard oncologic care according to national guidelines
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.
physical function for patients receiving palliative oncologic treatment
measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period.
Time frame: 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.
Time frame: 6 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Health-related Quality of life
Measured by EORTC-QLQ-C30
Time frame: 12 months
Health-related Quality of life
Measured by EORTC-QLQ-ELD14
Time frame: 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.
Time frame: 6 months
Number of patients who experience oncologic treatment toxicity
Treatment toxicity grade 3+ evaluated with Common Terminology Criteria for Adverse Events
Time frame: 6 months
Number of patients with adherence to initial oncologic treatment plan
Registration of dose reductions, discontinuations and delays of intended cancer treatment.
Time frame: 6 months
Degree of Polypharmacy (PP)
Degree of polypharmacy. Polypharmacy is defined as daily use of more than 5 prescription drugs.
Time frame: 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
Time frame: 3 months
Number of Potential Drug Interactions (PDI)
Using Stockley's Drug Interaction Database. Number of PDI will be registered for each patient
Time frame: 3 months
Overall survival
Measured from Geriatric 8 screening to time of death
Time frame: 12 months
Cancer specific survival
Measured from Geriatric 8 screening to time of death in patients with residual cancer
Time frame: 12 months
Plan to share: Undecided
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Odense University Hospital