Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05629676

Virtual Reality Intervention for Patients Undergoing BMT

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bone Marrow Transplant Complications Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMT-VR

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

Primary outcomes

  1. Feasibility of BMT-VR based on enrollment and intervention use rates

    Time frame: 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 outcomes

  1. Quality of Life (QOL) (FACT-BMT)

    Time frame: 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.

  2. Anxiety symptoms

    Time frame: 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)

  3. Depression symptoms

    Time frame: 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)

  4. Post-Traumatic Stress Disorder (PTSD)

    Time frame: 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

  5. Symptom Burden

    Time frame: 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

Other outcomes

  1. Coping

    Time frame: Up to week-24

    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

  2. Self-efficacy

    Time frame: Up to week-24

    assessed through the Cancer Self-Efficacy Scale-Transplant (CASE-t). The scale ranges from 0 to 170 with higher scores indicating higher self-efficacy

  3. Positive affect

    Time frame: Up to week-24

    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

  4. Gratitude

    Time frame: Up to week-24

    Assessed via the Gratitude questionnaire, a 6-item measure, with score range 6-42, with higher scores indicating more gratitude

  5. Usability of BMT-VR (only those randomized to BMT-VR)

    Time frame: Week-4

    Assessed via the System Usability Scale, which ranges from 0-100 with higher scores indicating better usability

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Nov 29, 2022
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.