Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
Contact:
Areej El-Jawahri, MD
617-724-4000
ael-jawahri@partners.org

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Areej El-Jawahri, MD
617-724-4000
ael-jawahri@partners.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.