Multimodal Psychosocial Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 6
- 主要终点
- Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire
研究概览
简要总结
The goal of this study is to evaluate whether a psychological intervention (BMT-CARE) is effective at improving the quality of life in caregivers and patients treated with hematopoietic cell transplant compared to usual care, and to identify critical facilitators and barriers for BMT-CARE implementation and adoption.
详细描述
This is a randomized clinical trial to determine whether a psychosocial intervention (BMT-CARE) is effective at improving the quality of life and reducing psychosocial distress of caregivers and patients treated with hematopoietic cell transplant (HCT). The BMT-CARE intervention was developed with the goal of improving the experience and needs of caregivers of patients treated with HCT.
Caregivers will be randomized into one of the two study groups: BMT-CARE plus usual care, or usual care.
Participation in this study is expected to last up to 180 days after HCT.
Investigators expect that about 400 caregivers and up to 400 patients treated with HCT will take part in this research study.
The National Institutes of Health is supporting this research by providing funding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult caregivers (≥18 years) relative or friend of a patient identified as living with them or having in-person contact with them at least twice a week.
- •Caregiver of a patient receiving allogeneic or autologous HCT for the treatment of cancer.
- •Ability to read and respond to survey questions in English, Spanish or with minimal assistance from an interpreter.
排除标准
- •Caregivers of patients undergoing HCT for a benign hematologic condition or undergoing outpatient HCT.
- •Caregivers with a major untreated psychiatric or cognitive condition which the treating oncology clinicians believes interferes with the capacity to provide informed consent.
- •Caregivers of patients who have already undergone HCT within the past 5 years
- •Patient Inclusion Criteria:
- •Adult patients (≥18 years) with a hematologic malignancy and planned admission for autologous or allogeneic HCT.
- •Ability to respond to questions in English, Spanish, or with minimal assistance from an interpreter.
结局指标
主要结局
Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire
时间窗: Up to 60 days post-HCT
Compare caregiver QOL as measured by the CARGOQOL between the two study groups. The CARGOQOL ranges from 0-100 with higher scores indicating better QOL
次要结局
- Caregiving burden as measured by the Caregiver Reaction Assessment (CRA) questionnaire(Up to 180 days post-HCT)
- Caregiver anxiety symptoms as measured by the Hospital Anxiety and Depression (HADS-Anxiety) Scale(Up to 180 days post-HCT)
- Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire(Up to 180 days post-HCT)
- Caregiver depression symptoms as measured by the Hospital Anxiety and Depression (HADS-Depression) Scale(Up to 180 days post-HCT)
- Caregiver self-efficacy as measured by the Cancer Self-Efficacy-transplant (CASE-t) questionnaire(Up to 180 days post-HCT)
- Caregiver coping as measured by the Measure of Current Status-A (MOCS-A) questionnaire(Up to 180 days post HCT)
研究者
El-Jawahri, Areej,M.D.
Associate Professor of Medicine
Massachusetts General Hospital