Improving Quality of Life in Older Patients With Frailty and Hematological Cancer Through Geriatric Assessment
Improving Quality of Life in Older Patients With Frailty and Hematological Cancer Through Geriatric Assessment and Treatment; A Randomized Controlled Trial. IMPROVE
Odense University Hospital
152 participants
Apr 2, 2024
INTERVENTIONAL
Conditions
Summary
The Improve study is a randomized controlled trial investigating the efficacy of adding comprehensive geriatric assessment and treatment to standard of care compared with standard of care in older, frail patients with hematological cancer. The investigators aim to recruit 152 study participants who will be randomized 1:1 to intervention- or control group. Study participants in the intervention group will receive the intervention comprehensive geriatric assessment and treatment integrated in the cancer treatment. Study participants in the control group will receive cancer treatment and evaluation of comorbidity and frailty as is usual standard at Department of Hematology. Primary endpoint is elderly functional Index at 12 weeks.
Eligibility
Inclusion Criteria6
- Age ≥70 years
- New diagnosis or progression/relapse of acute leukemia, chronic myeloid leukemia, chronic lymphocytic leukemia, myelodysplastic syndrome, lymphoma, multiple myeloma, chronic myelomonocytic leukemia or myelofibrosis
- Scheduled systemic cancer treatment or initiated systemic cancer treatment within 6 weeks
- Geriatric 8 frailty score of ≤14 at screening
- Life expectancy \> 6 months
- Not hospitalized at the time of inclusion
Exclusion Criteria5
- Current systemic treatment for other coexisting cancer. Patients receiving anti-hormone treatment for breast cancer or prostate cancer are not excluded, if no evidence of disease progression (radiological/biochemical) in past 3 months or if treatment is adjuvant.
- Having consulted a geriatric outpatient clinic past 6 months
- Patients in need of specialized neuro-rehabilitation
- Unable to understand Danish
- Unable to give written informed consent
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Interventions
CGA and treatment is as an outpatient evaluation by a geriatric medical specialist and nurse. Specific CGA components in this study include: * Assessment of comorbidity and treatments * Review of medications including potential adjustment * Assessment of current symptoms and health related issues including geriatric syndromes such as depression, dementia, delirium, nutritional problems, falls and fatigue * Objective examination including blood tests and electrocardiogram * Assessment of activities of daily living (ADL) and instrumental ADL through standardized questionnaires * Assessment of domestic conditions, including need for assistance * Assessment of physical function Based on findings, the geriatrician will initiate relevant interventions and follow-up as required
Locations(1)
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NCT06373471