Virtual Reality Intervention for Patients Undergoing BMT
- Conditions
- Bone Marrow Transplant Complications
- Interventions
- Behavioral: BMT-VR
- Registration Number
- NCT05629676
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
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:
1. Psychoeducation to enhance preparedness, manage expectations, and mobilize social supports.
2. Psychosocial skill building to promote effective coping and facilitate acceptance while living with uncertainty of treatment outcomes.
3. Self-care to promote effective coping and enhance patient's sense of control as they transition from inpatient to outpatient care
- Detailed Description
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.
In both groups, participants are asked to complete questionnaires (in-person, over the computer or telephone, or by mail) at baseline, 2, 4, 12, and 24 weeks after enrolling in the study.
It is expected about 80 participants will take part in this study.
Rocket VR Health, Inc. is supporting this research study by providing funding.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMT-VR Group BMT-VR * 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.
- Primary Outcome Measures
Name Time Method Feasibility of BMT-VR based on enrollment and intervention use rates 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
- Secondary Outcome Measures
Name Time Method Quality of Life (QOL) (FACT-BMT) Baseline to week-24 Assessed by the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) scale, which is 44-item QOL measure that assesses physical, social, emotional, and functional wellbeing, as well as bone marrow transplant-specific symptoms. Score range 0-164, with higher scores indicating better quality of life.
Post-Traumatic Stress Disorder (PTSD) Up to week-24 Assessed through the Post-traumatic Stress Disorder Checklist-Civilian Version, which is a 17-item PTSD Checklist that evaluates severity of PTSD symptoms. Scores range from 17-85 with higher scores indicating worse PTSD symptoms
Anxiety symptoms Up to week-24 Assessed by the self-reported Hospital Anxiety and Depression Scale (HADS), which is a 14-item measure with subscales to evaluate symptoms of anxiety and depression. The HADS consists of two subscales assessing depression and anxiety symptoms, with scores ranging from 0 (no distress) to 21 (maximum distress)
Symptom Burden Up to week-4 Assessed through the Edmonton Symptom Assessment Scale (ESAS-R), which is a 10-item measure to assess symptoms relevant to patients undergoing BMT. The ESAS-R score range 0-100 with higher scores indicating worse symptom burden
Depression symptoms Up to week-24 Assessed through the Patient Health Questionnaire-9 (PHQ-9), which is a 9-item measure that assesses major depression symptoms. The HADS consists of two subscales assessing depression and anxiety symptoms, with scores ranging from 0 (no distress) to 21 (maximum distress)
Trial Locations
- Locations (1)
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States