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

ConditionsHematologic Malignancy Treatment Adherence Treatment Complication Frailty Quality of Life

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Comprehensive geriatric assessment (CGA) and treatment
Other intervention
CGA and treatment is as an outpatient evaluation by a geriatric medical specialist and nurse. Specific CGA components in this study include: * Assessment of comorbidity and treatments * Review of medications including potential adjustment * Assessment of current symptoms and health related issues including geriatric syndromes such as depression, dementia, delirium, nutritional problems, falls and fatigue * Objective examination including blood tests and electrocardiogram * Assessment of activities of daily living (ADL) and instrumental ADL through standardized questionnaires * Assessment of domestic conditions, including need for assistance * Assessment of physical function Based on findings, the geriatrician will initiate relevant interventions and follow-up as required

Treatment groups

152 Participants

are divided into 2 treatment groups

Group A: Intervention armExperimental treatment 1 intervention

Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

Elderly functional Index

The Elderly Functional Index (ELFI) is calculated using the physical functioning, role functioning, and social functioning of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) core 30, and the mobility item of the EORTC-QLQ-elderly 14 (ELD14) questionnaire. ELFI is calculated at baseline and at 12- and 26- week follow-up. Maximum value of ELFI is 100. Minimum value of ELFI is 0. Higher score indicates higher function.

Time frame