Ignite Creation Date:
2024-05-06 @ 6:20 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05629676
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2022-11-17
Brief Title:
Virtual Reality Intervention for Patients Undergoing BMT
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Randomized Controlled Trial of a Virtual Reality Psychosocial Intervention to Promote Coping for Patients Undergoing Bone Marrow Transplantation BMT-VR
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients sense of control as they transition from inpatient to outpatient care
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 patients 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 11 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
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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None