Quality of Life Clinical Trial
— IMPROVEOfficial title:
Improving Quality of Life in Older Patients With Frailty and Hematological Cancer Through Geriatric Assessment and Treatment; A Randomized Controlled Trial. IMPROVE
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.
Status | Recruiting |
Enrollment | 152 |
Est. completion date | September 30, 2026 |
Est. primary completion date | March 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Odense University Hospital | Odense C |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital | Danish Cancer Research Foundation, The Dagmar Marshall Foundation, Velux Fonden |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 12 and 26 weeks after inclusion | |
Secondary | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). | The questionnaire contains functional and symptom subscales. Maximum value for scales is 100 and minimum values is 0. A higher score indicates higher function for functional scales and more symptoms for symptom scales. | 12 and 26 weeks after inclusion | |
Secondary | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Elderly14 (EORTC QLQ-Eld14). | The questionnaire contains functional scales and symptom scales. Maximum value for scales is 100 and minimum values is 0. A higher score indicates higher function for functional scales and more symptoms for symptom scales | 12 and 26 weeks after inclusion | |
Secondary | Handgrip strength | Handgrip strength is measured in kilograms with a handgrip dynamometer | 12 and 26 weeks after inclusion | |
Secondary | 30-second chair stand test | 30-second chair stand test is measured in number of stand-up-and-sit-downs in 30 seconds | 12 and 26 weeks after inclusion | |
Secondary | Treatment toxicity | Endpoint is assessed as prevalence of grade > 1 adverse events according to Common Terminology Criteria for Adverse Events Version 5.0 at baseline, 12 and 26 weeks after inclusion | Baseline, 12 and 26 weeks after inclusion | |
Secondary | Adherence to hematological cancer treatment | Alterations to original cancer treatment plan yes/no | 12 and 26 weeks after inclusion | |
Secondary | Polypharmacy yes/no | Polypharmacy is defined as use of 5 or more daily medications | 12 and 26 weeks after inclusion | |
Secondary | Unplanned hospital admissions | rates and hospital days | 26 and 52 weeks after inclusion | |
Secondary | Overall and cancer specific survival | survival proportion and cancer specific survival proportion | 26 and 52 weeks after inclusion |
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