NCT06373471 Improving Quality of Life in Older Patients With Frailty and Hematological Cancer Through Geriatric Assessment
| NCT ID | NCT06373471 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Odense University Hospital |
| Condition | Hematologic Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 152 participants |
| Start Date | 2024-04-02 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 152 participants in total. It began in 2024-04-02 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Henrik Frederiksen
PRINCIPAL INVESTIGATOR
Odense University Hospital
Frequently Asked Questions
Who can join the NCT06373471 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Hematologic Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06373471 currently recruiting?
Yes, NCT06373471 is actively recruiting participants. Contact the research team at henrik.frederiksen@rsyd.dk for enrollment information.
Where is the NCT06373471 trial being conducted?
This trial is being conducted at Odense C, Denmark.
Who is sponsoring the NCT06373471 clinical trial?
NCT06373471 is sponsored by Odense University Hospital. The principal investigator is Henrik Frederiksen at Odense University Hospital. The trial plans to enroll 152 participants.