Feasibility of a Multidisciplinary Approach to Circumvent Healthspan Decline After Allogeneic Hematopoietic Cell Transplantation in Older Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility of multidisciplinary team (MDT) (met 90 percent threshould, yes / no)
研究概览
简要总结
This clinical trial studies the usefulness and process of a multidisciplinary intervention, where patients see multiple healthcare professionals, aimed at improving fitness and the ability to bounce back after transplant for older adults with blood cancers planned for stem cell transplantation. Using a multidisciplinary team approach may increase patients' ability to withstand the transplant by optimizing health to better prepare patients for the expected complications after stem cell transplantation.
详细描述
PRIMARY OBJECTIVE:
I. Evaluate the feasibility of delivering a geriatric assessment guided by a multi-disciplinary team (MDT) intervention before allogeneic hematopoietic cell transplantation (HCT) in older patients.
SECONDARY OBJECTIVES:
I. Establish successful dose intensity of resiliency bolstering. II. Describe HCT utilization among enrolled patients. III. Create a standardized and exportable library of MDT-facilitated interventions.
IV. Estimate the benefit derived from the MDT approach compared to historic controls for day +100 outcomes of falls, delirium and functional decline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented informed consent of the participant
- •>= 65 years at time of planned HCT infusion
- •Anticipated to be candidate for allogeneic transplant per treating physician at the time of enrollment
- •Ability to read English, Spanish or Mandarin. Other languages will be acceptable with principal investigator (PI) agreement if surveys are available and language does not preclude completing study procedures
- •Any conditioning regimen and allogeneic donor permitted
- •Hematologic malignancy or disease as indication for HCT
- •Willing and able to complete study requirements
排除标准
- •Prior allogeneic stem cell transplant
- •Syngeneic donors for HCT
- •Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
研究组 & 干预措施
Supportive care (MDT-intervention)
Patients participate in the MDT-intervention including access to a HCT physician, a geriatrician, physical or occupational therapist, dietician, and a social worker for three months before HCT and up to 100 days after HCT.
干预措施: Health Promotion (Other)
Supportive care (MDT-intervention)
Patients participate in the MDT-intervention including access to a HCT physician, a geriatrician, physical or occupational therapist, dietician, and a social worker for three months before HCT and up to 100 days after HCT.
干预措施: Quality-of-Life Assessment (Other)
Supportive care (MDT-intervention)
Patients participate in the MDT-intervention including access to a HCT physician, a geriatrician, physical or occupational therapist, dietician, and a social worker for three months before HCT and up to 100 days after HCT.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Feasibility of multidisciplinary team (MDT) (met 90 percent threshould, yes / no)
时间窗: Up to 1 year
Patients are expected to see 6 providers. Success is defined as enrolled patients seen at least 4 out of six providers. The study will meet feasibility endpoint if 90 percent or more of the enrolled patients are flagged as successful. Each patient will be measured as success or failure according to these rules.
次要结局
- Rate of hematopoietic cell transplantation (HCT) utilization(Up to 1 year)
- Dose intensity of resiliency bolstering(Up to 1 year)
- Library of MDT-facilitated intervention(Up to 1 year)
- Functional independent survival (FIS)(Days 30, 60, 100)