Geriatric-guided Care Versus Conventional Care in Elderly Unfit/Frail Patients With Diffuse Large B-cell Lymphoma in First Line Treatment. The Elderly Project 2.0: Non-randomized Cluster Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 170
- 试验地点
- 24
- 主要终点
- To evaluate whether a geriatric-guided approach improves health-related quality of life (HRQL) in elderly patients with DLBCL eligible for first-line chemoimmunotherapy, compared to a conventional approach.
研究概览
简要总结
The aim of this multicenter, non-randomized, cluster controlled trial study is to evaluate the impact of a geriatric-guided approach with a pro-active rehabilitative/nutritional plan for elderly unfit/frail DLBCL patients eligible for receiving chemoimmunotherapy according to the sGA, versus a conventional approach with onco-hematological treatment alone.
A key innovation element of this project is to use a geriatric-guided approach to improve the global management of all frailty aspects (nutritional, functional, cognitive, social), chasing a better tolerance and completion rate of treatment, tailoring safety and efficacy of therapies in unfit/frail DLBCL patients.
This study may lead to a personalized approach for elderly DLBCL patients, taking into account a multidisciplinary and fully-integrated program, with the primary aim of improving the quality of life of patients and their families.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Diagnosis of DLBCL or Follicular Lymphoma (FL) grade IIIB.
- •Age ≥ 70 years.
- •UNFIT or FRAIL status according to sGA evaluated by the onco-hematologist at baseline.
- •Patients eligible to a curative intent standard first line chemoimmunotherapy.
- •Ability to understand and willingness to comply with study procedures.
- •Signature of a written informed consent.
排除标准
- •Patients not meeting at least one of the inclusion criteria listed above.
- •Refuse to sign a written informed consent.
研究组 & 干预措施
Geriatric-guided supportive care
Patients will be treated for lymphoma according to standard clinical practice. Patients will receive a geriatric-guided supportive care with structured geriatric consultation, along with a nutritional and physiotherapy evaluation, before treatment initiation and with subsequent follow-up assessments aimed at optimizing comorbidity management, nutritional and functional status, along with treatment tolerance.
干预措施: Geriatric-guided supportive care (Other)
Conventional supportive care
Patients will be treated for lymphoma according to standard clinical practice. Patients will receive supportive care according to standard clinical practice without systematic geriatric input.
干预措施: Conventional supportive care (Other)
结局指标
主要结局
To evaluate whether a geriatric-guided approach improves health-related quality of life (HRQL) in elderly patients with DLBCL eligible for first-line chemoimmunotherapy, compared to a conventional approach.
时间窗: From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning)
Change in the Global Health Status/QoL score of the EORTC Quality of Life Core 30 From baseline to end of treatment (6 months after enrollment). EORTC QLQ-C30 questionnaire: ranking from 1 ("not at all") to 4 ("very much").
次要结局
- To compare the treatment completion rate between groups(From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning))
- To assess changes in the functioning scales and symptom scales of the EORTC QLQ-C30 performed at baseline, 3, 6, and 12 months in both study groups (geriatric-guided vs conventional approach)(From the beginning up to the end of study (up to 36 months))
- To assess changes in simplified Geriatric Assessment (sGA) performed at baseline, 3, 6, and 12 months in both study groups (geriatric-guided vs conventional approach)(From the beginning up to the end of study (up to 36 months))
- To compare eventual dose reductions of therapeutic treatments between groups.(From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning))
- To evaluate the prognostic impact of sGA on overall survival (OS)(From the beginning up to the end of study (up to 36 months))
- To assess early mortality rate (within 90 days) in the two groups.(From the beginning of the study up to 90 days after last enrolled patient (up 27 months from study beginning))
- To compare overall response rate (ORR) and complete response rate (CRR) between groups.(From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning))
- To evaluate progression-free survival (PFS) and overall survival (OS) in the two groups.(From the beginning up to the end of study (up to 36 months))
- To compare hospitalization rates between groups.(From the beginning up to the end of study (up to 36 months))
- To assess caregiver quality of life and caregiver-related outcomes measured by the CareGiver Oncology Quality of life questionnaire (CarGOQoL) at baseline, 3, 6, and 12 months in both groups.(From the beginning up to the end of study (up to 36 months))
- To evaluate modifications in the Fried frailty index assessed only in the geriatric-guided arm (performed at baseline, 3, 6, and 12 months) and if there is a concordance between sGA and Fried score.(From the beginning up to the end of study (up to 36 months))
- To compare median hospital stay between groups.(From the beginning up to the end of study (up to 36 months))
- To compare emergency department access rate between groups.(From the beginning up to the end of study (up to 36 months))
- To compare hospice admission rate between groups.(From the beginning up to the end of study (up to 36 months))
- To compare eventual dose delays of therapeutic treatments between groups.(From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning))
- To evaluate the prognostic impact of Body Mass Index (BMI) on overall survival (OS).(From the beginning up to the end of study (up to 36 months))
- To evaluate the prognostic impact of serum albumin on overall survival (OS).(From the beginning up to the end of study (up to 36 months))
- To evaluate the prognostic impact of caregiver availability on overall survival (OS).(From the beginning up to the end of study (up to 36 months))