Virtual Reality Intervention for Patients Undergoing BMT

Mass General Brigham

Status: Active, not recruiting

Conditions: Bone Marrow Transplant Complications

Treatments: Behavioral: BMT-VR

Study type: Interventional

Funder types: Other

Identifiers

NCT05629676

22-486

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

BMT-VR Group

Experimental group

Description:

* 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.

Treatment:

Behavioral: BMT-VR

Usual care

No Intervention group

Description:

* Participants will receive usual transplant care by their BMT team * Participants will complete study questionnaires to assess their quality of life and psychological outcomes