Virtual Reality Intervention for Patients Undergoing BMT

NCT ID: NCT05629676

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-20
• Study Completion Date: 2026-12-30

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.

Conditions

Bone Marrow Transplant Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

BMT-VR

Intervention Type: BEHAVIORAL

BMT-VR is a novel psychosocial intervention that addresses the supportive care needs of patients undergoing BMT. BMT-VR includes six sections focused on: 1) psychoeducation to help patients increase their awareness to stress and challenges that may accompany the BMT journey; 2) supportive psychotherapy strategies to help patients adjust to the intense BMT hospitalization; 3) psychosocial skill building to promote mindfulness, acceptance and gratitude while living with uncertainty; 4) psychoeducation to manage expectations and enhance preparedness for extended hospitalization; 5) psychosocial skill-building to promote effective coping; and 6) an overview of psychosocial skills grounded in cognitive behavior therapy, mindfulness, and positive psychology

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

BMT-VR

BMT-VR is a novel psychosocial intervention that addresses the supportive care needs of patients undergoing BMT. BMT-VR includes six sections focused on: 1) psychoeducation to help patients increase their awareness to stress and challenges that may accompany the BMT journey; 2) supportive psychotherapy strategies to help patients adjust to the intense BMT hospitalization; 3) psychosocial skill building to promote mindfulness, acceptance and gratitude while living with uncertainty; 4) psychoeducation to manage expectations and enhance preparedness for extended hospitalization; 5) psychosocial skill-building to promote effective coping; and 6) an overview of psychosocial skills grounded in cognitive behavior therapy, mindfulness, and positive psychology

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

El-Jawahri, Areej,M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Areej El-Jawahri, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

22-486

Identifier Type: -

Identifier Source: org_study_id