Improving Quality of Life in Older Patients With Frailty and Hematological Cancer Through Geriatric Assessment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorOdense University Hospital

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Comprehensive geriatric assessment (CGA) and treatment

Treatment groups

152 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Odense University Hospital

Lead sponsor

Velux Fonden

Collaborator

Danish Cancer Research Foundation

Collaborator

The Dagmar Marshall Foundation

Collaborator