Improving Quality of Life in Older Patients With Frailty and Hematological Cancer Through Geriatric Assessment
Recruiting now · Not applicable
Conditions studied: Hematologic Malignancy, Treatment Adherence, Treatment Complication, Frailty, Quality of Life
In brief
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.
Key facts
- Study ID
- NCT06373471
- Run by
- Odense University Hospital
- People needed
- 152
- Starts
- 2024-04-02
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2024-04-18
Who can join
Age: 70 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Odense University Hospital — Odense C, Denmark (enrolling)
Full record on ClinicalTrials.gov
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