Virtual Reality Intervention for Patients Undergoing BMT

Randomized Controlled Trial of a Virtual Reality Psychosocial Intervention to Promote Coping for Patients Undergoing Bone Marrow Transplantation (BMT-VR)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Bone Marrow Transplant Complications
• Intervention / Treatment: Behavioral: BMT-VR

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of BMT-VR based on enrollment and intervention use rates	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	Baseline to week-24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life (QOL) (FACT-BMT)	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.	Baseline to week-24
Anxiety symptoms	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)	Up to week-24
Depression symptoms	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)	Up to week-24
Post-Traumatic Stress Disorder (PTSD)	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	Up to week-24
Symptom Burden	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	Up to week-4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coping	Assessed through the Measure of Current Status (MOCS), which measures perceived coping skills. Score ranges from 0-52 with higher scores indicating higher coping skills	Up to week-24
Self-efficacy	assessed through the Cancer Self-Efficacy Scale-Transplant (CASE-t). The scale ranges from 0 to 170 with higher scores indicating higher self-efficacy	Up to week-24
Positive affect	Assessed via the Positive and Negative Affect Schedule (PANAS), a 10-item measure with a score range of 10-50, with higher scores indicating more positive affect	Up to week-24
Gratitude	Assessed via the Gratitude questionnaire, a 6-item measure, with score range 6-42, with higher scores indicating more gratitude	Up to week-24
Usability of BMT-VR (only those randomized to BMT-VR)	Assessed via the System Usability Scale, which ranges from 0-100 with higher scores indicating better usability	Week-4

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Areej El-Jawahri, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Actual): December 30, 2024
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: November 17, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: PTSD; Depression; Anxiety; BMT; Bone Marrow Transplant; Allogeneic BMT; Autologous BMT
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Stress Disorders, Traumatic; Behavior; Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 22-486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No