Short 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 152 older, frail patients with hematological cancer. Primary endpoint is patient reported physical function assessed with Elderly functional Index (ELFI)

Rationale

Age is a strong risk factor for developing hematological cancer and can be associated with frailty due to comorbidity, weight loss, depression, dementia, etc. Nonetheless, even severely affected and frail patients are often eligible for hematological cancer treatment, though frailty affects patient´s ability to tolerate chemotherapy and may thus negatively affect the outcome of the cancer treatment. The comprehensive geriatric assessment (CGA) is a multidimensional, interdisciplinary diagnostic process addressing core domains related to frailty and incorporating treatment plans focusing on maximizing overall health with aging. The overarching aim of the study is to investigate effects of integrating CGA and treatment on quality of life, complications, and prognosis in older, frail patients with hematological cancer scheduled for systemic treatment using a RCT design.

Description of the cohort

Study participants will be recruited from Danish Hematological departments. Inclusion criteria are: - 70 years or older - Diagnosed with leukemia, lymphoma, myelodysplastic syndrome, myelofibrosis or multiple myeloma - Scheduled systemic cancer treatment - Geriatric 8 frailty score ≤14 at screening - Life expectancy > 6 months

Data and biological material

Data included are demographic data, clinical data including hematological cancer diagnosis, stage and prognostic score, cancer treatment plan, treatment toxicity, comorbidity, screening for cognitive impairment, screening for depression, daily medications, quality of life assessed with questionnaires (EORTC QLQ-C30 and EORT QLQ-ELD14), activity of daily living, nutrition status, handgrip strength, 30 second chair stand test, unplanned hospital admissions, treatment effect and survival

Collaborating researchers and departments

Geriatric departmentment, OUH

• Professor, Consultant Jesper Ryg