Clinical trial NCT05629676: Virtual Reality Intervention for Patients Undergoing BMT
Official title: Randomized Controlled Trial of a Virtual Reality Psychosocial Intervention to Promote Coping for Patients Undergoing Bone Marrow Transplantation (BMT-VR)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bone Marrow Transplant Complications
Keywords: Bone Marrow Transplant
PTSD
Anxiety
Depression
BMT
Autologous BMT
Allogeneic BMT
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Feasibility of BMT-VR based on enrollment and intervention use rates
timeFrame: Baseline to week-24
Secondary outcomes:
measure: Quality of Life (QOL) (FACT-BMT)
timeFrame: Baseline to week-24
measure: Anxiety symptoms
timeFrame: Up to week-24
measure: Depression symptoms
timeFrame: Up to week-24
measure: Post-Traumatic Stress Disorder (PTSD)
timeFrame: Up to week-24
measure: Symptom Burden
timeFrame: Up to week-4
Other outcomes:
measure: Coping
timeFrame: Up to week-24
measure: Self-efficacy
timeFrame: Up to week-24
measure: Positive affect
timeFrame: Up to week-24
measure: Gratitude
timeFrame: Up to week-24
measure: Usability of BMT-VR (only those randomized to BMT-VR)
timeFrame: Week-4
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Areej El-Jawahri, MD
role: PRINCIPAL_INVESTIGATOR
References: