Improving Quality of Life in Older Patients With Frailty and Hematological Cancer Through Geriatric Assessment and Treatment; A Randomized Controlled Trial. IMPROVE

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Odense University Hospital
RECRUITING
Odense C
Contact Information
Primary
Henrik Frederiksen
henrik.frederiksen@rsyd.dk
+45 21849307
Backup
Nina Andersen
nina.andersen@rsyd.dk
+45 40437488
Time Frame
Start Date: 2024-04-02
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 152
Treatments
Experimental: Intervention arm
Comprehensive Geriatric Assessment and treatment
No_intervention: Control
Standard hematological evaluation of comorbidity and needs during hematological cancer treatment.
Related Therapeutic Areas
Sponsors
Collaborators: The Dagmar Marshall Foundation, Velux Fonden, Danish Cancer Research Foundation
Leads: Odense University Hospital

This content was sourced from clinicaltrials.gov