Improving Quality of Life in Older Patients With Frailty and Hematological Cancer Through Geriatric Assessment and Treatment; A Randomized Controlled Trial. IMPROVE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Elderly functional Index
研究概览
简要总结
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.
详细描述
RESEARCH PLAN
STUDY DESIGN IMPROVE aims to investigate the efficacy of adding comprehensive geriatric assessment (CGA) 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 CGA and treatment integrated in the cancer treatment. Study participants in the control group will receive cancer treatment and evaluation as well as management of comorbidity, frailty and needs as is the current standard at Departments of Hematology.
PARTICIPANTS AND TIMELINES One hundred and fifty two patients complying with inclusion and exclusion criteria detailed below will be recruited at participating Hematological Departments in Denmark. Study period is 52 weeks for each study participant.
INTERVENTIONS AND ASSESSMENTS Hematological treatment plan Study participants will be given a hematological cancer treatment plan according to standard guidelines at the discretion of the treating physician at the Department of Hematology. The hematological treatment plan will not be altered because of participation in IMPROVE study. Data on whether the cancer treatment is prescribed with a reduced dose-intensity due to frailty or later reduced due to toxicity will be collected.
CGA and treatment CGA and treatment will be performed before or after initiation of hematological cancer treatment, and within 6 weeks from inclusion. Performing CGA shall not delay initiation of hematological cancer treatment if immediate treatment is necessary. A geriatrician together with a geriatric nurse will perform CGA at the Department of Geriatric Medicine. CGA is more thoroughly described elsewhere in this report. Based on CGA findings, the geriatrician will initiate relevant further investigation(s), intervention(s) and treatment(s) if indicated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Elderly functional Index
时间窗: 12 and 26 weeks after inclusion
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.
次要结局
- Adherence to hematological cancer treatment(12 and 26 weeks after inclusion)
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).(12 and 26 weeks after inclusion)
- Polypharmacy yes/no(12 and 26 weeks after inclusion)
- Overall and cancer specific survival(26 and 52 weeks after inclusion)
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Elderly14 (EORTC QLQ-Eld14).(12 and 26 weeks after inclusion)
- Treatment toxicity(Baseline, 12 and 26 weeks after inclusion)
- Unplanned hospital admissions(26 and 52 weeks after inclusion)
- Handgrip strength(12 and 26 weeks after inclusion)
- 30-second chair stand test(12 and 26 weeks after inclusion)