VR Therapy for Bone Marrow Transplant

Overseen By Areej El-Jawahri, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Benign hematologic conditions, Outpatient BMT, Unstable psychiatric conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: During hospitalization

80 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment BMT-VR for patients undergoing bone marrow transplant?

Research shows that virtual reality (VR) can help reduce symptoms like anxiety, depression, and pain in patients undergoing treatments similar to bone marrow transplants. VR has also been effective in improving quality of life and managing symptoms in cancer patients, suggesting it could be beneficial for those undergoing bone marrow transplants. ^{1 2 3 4 5}

How is the BMT-VR treatment different from other treatments for bone marrow transplant patients?

BMT-VR is unique because it uses virtual reality as a psychosocial intervention to help bone marrow transplant patients cope with psychological stress and improve their quality of life, unlike traditional treatments that focus primarily on medical and physical aspects. ^{6 7 8 9 10}

What is the purpose of this trial?

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

Research Team

Areej El-Jawahri, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for English-speaking adults over 18 with blood cancer, admitted for bone marrow transplantation (BMT). It's not suitable for those with benign blood conditions or acute psychiatric/cognitive issues that prevent informed consent or following the study.

Inclusion Criteria

I am over 18 and have a blood cancer, scheduled for a bone marrow transplant.

Ability to comprehend, read, and respond to questions in English as BMT-VR is only available in English

Exclusion Criteria

I am receiving a bone marrow transplant as an outpatient.

Patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures

I am having a bone marrow transplant for a non-cancerous blood condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the BMT-VR intervention during their BMT hospitalization, which includes six sections focused on education and coping strategies

During hospitalization

Inpatient

Follow-up

Participants are monitored for quality of life and psychological outcomes through questionnaires at baseline, 2, 4, 12, and 24 weeks

24 weeks

Questionnaires at baseline, 2, 4, 12, and 24 weeks

Extension

Participants may continue to be monitored for long-term outcomes beyond the initial follow-up period

Beyond 24 weeks

Treatment Details

Interventions

• BMT-VR

Trial Overview The study tests a virtual reality (VR) program designed to improve life quality and reduce stress in BMT patients. Participants will either receive this VR intervention plus standard care, or just standard care, assigned randomly.

Participant Groups

Group I: BMT-VR Group Experimental Treatment 1 Intervention

* 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.

Group II: Usual care Active Control 1 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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

Virtual reality (VR) interventions have been shown to significantly reduce symptoms of anxiety, depression, pain, and fatigue in cancer patients, based on a meta-analysis of 6 studies.

The findings suggest that while VR is effective for managing acute symptoms during cancer treatment, further research is needed to explore its benefits for long-term side effects in cancer survivorship care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-Analysis of the Efficacy of Virtual Reality-Based Interventions in Cancer-Related Symptom Management. Zeng, Y., Zhang, JE., Cheng, ASK., et al.[2020]

A systematic review of 17 studies involving 799 cancer patients found that virtual reality (VR) significantly improved pain, anxiety, upper extremity function, and quality of life after intervention, indicating its efficacy in cancer rehabilitation.

VR not only alleviated physical and psychological symptoms but also showed positive effects on cognitive function, suggesting it can be a valuable addition to comprehensive cancer rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of virtual reality on physical, cognitive, and psychological outcomes in cancer rehabilitation: a systematic review and meta-analysis. Hao, J., Li, Y., Swanson, R., et al.[2023]

In a study involving 20 hospitalized participants aged 19-70, virtual reality (VR) sessions significantly improved 8 out of 10 symptoms related to distress, including depression, anxiety, and pain, after receiving allogeneic hematopoietic stem cell transplantation.

The findings suggest that VR is a promising low-cost intervention for alleviating distressing symptoms in patients post-transplant, highlighting its potential for further research in managing prolonged hospitalizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality for Symptom Management in Patients Undergoing Hematopoietic Stem Cell Transplantation: A Quality Improvement Initiative. Vega, C., Whitney, RL., Hannah, J., et al.[2022]

A study involving 42 adult patients undergoing hematopoietic stem cell transplantation found that guided imagery using virtual reality improved health-related quality of life scores, although these improvements were not statistically significant.

The research highlighted a significant positive correlation between quality of life, fatigue, and neutropenia across different stages of treatment, suggesting that integrative practices like guided imagery could help address these challenges during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided imagery relaxation in quality of life of patients undergoing hematopoietic stem cell transplantation: a quasi-experiment. Silva, LAAD., Machado, CAM., Santana, EO., et al.[2022]

Virtual reality (VR) therapy has shown potential to improve clinical outcomes, such as reduced pain and anxiety, in adult patients undergoing surgical procedures, based on a review of 18 studies.

Factors like patient comfort and healthcare worker concerns about cost-effectiveness and infection control influence the acceptability and feasibility of VR therapy in acute care settings, indicating a need for further research to solidify its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality interventions and the outcome measures of adult patients in acute care settings undergoing surgical procedures: An integrative review. Wang, S., Lim, SH., Aloweni, FBAB.[2022]

Quality of life (QOL) assessments are becoming essential for evaluating the outcomes of bone marrow transplantation (BMT), highlighting both acute and long-term psychosocial challenges faced by recipients.

Interventions such as addressing coping styles, promoting aerobic exercise, reducing anxiety, and ensuring consistent support from healthcare staff can significantly enhance the psychosocial adjustment and overall QOL of BMT patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life following bone marrow transplantation. Wingard, JR.[2019]

In a study of 437 patients evaluated for bone marrow transplantation, 31% exhibited signs of depression, indicating a significant prevalence of psychological distress among this population.

Psychological distress was linked to lower performance scores and levels of mastery and optimism, highlighting the importance of assessing mental health and providing psychiatric support for patients undergoing evaluation for BMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological distress among adult patients being evaluated for bone marrow transplantation. Baker, F., Marcellus, D., Zabora, J., et al.[2007]

Bone marrow transplantation (BMT) is a critical and increasingly common treatment for life-threatening diseases in both children and adults, but it comes with significant physical and psychological risks.

The study identifies seven key psychiatric and psychosocial concerns related to BMT, highlighting the importance of research and interventions to support patients, donors, and their families throughout the transplantation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychiatric and psychosocial aspects of bone marrow transplantation. Andrykowski, MA.[2007]

Art therapy was successfully introduced as a supportive intervention for nine adult bone marrow transplant patients in isolation, with sessions held twice a week, demonstrating its feasibility in a clinical setting.

Patients effectively used art therapy to enhance positive feelings, reduce distress, and explore existential issues, indicating that this non-verbal approach may particularly benefit those facing emotional conflicts related to life and death.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Art therapy with adult bone marrow transplant patients in isolation: a pilot study. Gabriel, B., Bromberg, E., Vandenbovenkamp, J., et al.[2019]

Research on bone marrow transplantation (BMT) has expanded beyond biomedical aspects to include important psychosocial issues, highlighting the need for a holistic approach to patient care.

Key areas of psychosocial research in BMT include decision-making before the procedure, coping and quality of life after the procedure, and the experiences of bone marrow donors, indicating that understanding these factors is crucial for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial factors in bone marrow transplantation: a review and recommendations for research. Andrykowski, MA.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Meta-Analysis of the Efficacy of Virtual Reality-Based Interventions in Cancer-Related Symptom Management. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Effects of virtual reality on physical, cognitive, and psychological outcomes in cancer rehabilitation: a systematic review and meta-analysis. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality for Symptom Management in Patients Undergoing Hematopoietic Stem Cell Transplantation: A Quality Improvement Initiative. [2022]

4. Thailand pubmed.ncbi.nlm.nih.gov

Guided imagery relaxation in quality of life of patients undergoing hematopoietic stem cell transplantation: a quasi-experiment. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Virtual reality interventions and the outcome measures of adult patients in acute care settings undergoing surgical procedures: An integrative review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Quality of life following bone marrow transplantation. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Psychological distress among adult patients being evaluated for bone marrow transplantation. [2007]

8. England pubmed.ncbi.nlm.nih.gov

Psychiatric and psychosocial aspects of bone marrow transplantation. [2007]

9. England pubmed.ncbi.nlm.nih.gov

Art therapy with adult bone marrow transplant patients in isolation: a pilot study. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Psychosocial factors in bone marrow transplantation: a review and recommendations for research. [2019]