Randomized Controlled Trial of a Virtual Reality Psychosocial Intervention to Promote Coping for Patients Undergoing Bone Marrow Transplantation (BMT-VR)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Feasibility of BMT-VR based on enrollment and intervention use rates
研究概览
简要总结
The goal of this research study is to test the feasibility and preliminary efficacy of using a virtual reality (VR) psychosocial intervention for improving quality of life and psychological distress in patients hospitalized for bone marrow transplantation (BMT). Participants will be randomly assigned into one of the study groups: the virtual reality psychosocial intervention (BMT-VR) + usual care versus usual care alone.
The BMT-VR intervention has several components:
- Psychoeducation to enhance preparedness, manage expectations, and mobilize social supports.
- Psychosocial skill building to promote effective coping and facilitate acceptance while living with uncertainty of treatment outcomes.
- Self-care to promote effective coping and enhance patient's sense of control as they transition from inpatient to outpatient care
详细描述
Patients undergoing BMT endure substantial physical and psychological symptoms during a prolonged hospitalization with significant risk of complications, which negatively impact their overall quality of life. There is a critical need to develop innovative supportive care interventions to improve the quality of life and care of patients undergoing BMT.
This is a single-center, randomized, controlled research study to test the feasibility and preliminary efficacy of BMT-VR for improving quality of life and reducing psychological stress for patients undergoing BMT. BMT-VR is a self-administered virtual reality psychosocial intervention to address the supportive care needs of patients undergoing BMT.
Participants will be recruited and randomized in 1:1 fashion to BMT-VR + usual care versus usual care alone, stratified by transplant type (autologous vs. allogenic BMT)
Participants randomly assigned to BMT-VR group will receive usual transplant care by their BMT team and will also be given a virtual reality headset to engage with BMT-VR during their BMT hospitalization. Participants will complete six sections focused on educating them about BMT and helping them manage the physical and emotional symptoms with the BMT process.
Participants randomly assigned to the usual care group will receive usual transplant care by their BMT team and will not be given access to the BMT-VR intervention.
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 patients (age > 18 years) with hematologic malignancy admitted for autologous or allogeneic BMT
- •Ability to comprehend, read, and respond to questions in English as BMT-VR is only available in English
排除标准
- •Patients undergoing BMT for benign hematologic conditions
- •Patients undergoing outpatient BMT
- •Patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures
研究组 & 干预措施
BMT-VR Group
- Participants will complete the BMT-VR intervention during their BMT hospitalization, which contains six sections.
- Participants will receive usual transplant care by their BMT team
- Participants will complete study questionnaires to assess their quality of life and psychological outcomes
- 10-20 participants will complete exit interviews to ascertain more feedback on the BMT-VR intervention.
干预措施: BMT-VR (Behavioral)
Usual care
- Participants will receive usual transplant care by their BMT team
- Participants will complete study questionnaires to assess their quality of life and psychological outcomes
结局指标
主要结局
Feasibility of BMT-VR based on enrollment and intervention use rates
时间窗: Baseline to week-24
The intervention will be deemed feasible if 60% of eligible patients are enrolled and of those enrolled and randomized to BMT-VR, 60% complete at least 60% of the intervention modules
次要结局
- Quality of Life (QOL) (FACT-BMT)(Baseline to week-24)
- Post-Traumatic Stress Disorder (PTSD)(Up to week-24)
- Anxiety symptoms(Up to week-24)
- Symptom Burden(Up to week-4)
- Depression symptoms(Up to week-24)
研究者
El-Jawahri, Areej,M.D.
Principal Investigator
Massachusetts General Hospital