Virtual Reality Intervention for Patients Undergoing BMT

NCT05629676 | Active Not Recruiting

• 1 other identifier: 22-486
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. 1.Psychoeducation to enhance preparedness, manage expectations, and mobilize social supports.
2. 2.Psychosocial skill building to promote effective coping and facilitate acceptance while living with uncertainty of treatment outcomes.
3. 3.Self-care to promote effective coping and enhance patient's sense of control as they transition from inpatient to outpatient care

Conditions

Bone Marrow Transplant Complications

Keywords

Bone Marrow Transplant; PTSD; Anxiety; Depression; BMT; Autologous BMT; Allogeneic BMT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Quality of Life (QOL) (FACT-BMT)

  Baseline to week-24

• Anxiety symptoms

  Up to week-24

• Depression symptoms

  Up to week-24

• Post-Traumatic Stress Disorder (PTSD)

  Up to week-24

• Symptom Burden

  Up to week-4

Other Outcomes (5)

• Coping

  Up to week-24

• Self-efficacy

  Up to week-24

• Positive affect

  Up to week-24

Study Arms (2)

BMT-VR Group

EXPERIMENTAL

* 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

Usual care

NO INTERVENTION

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

Interventions

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

BMT-VR Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Areej El-Jawahri, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: November 29, 2022
• Study Start: December 20, 2022
• Primary Completion: December 30, 2024
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)