RECRUITING

A Nature-Based Virtual Reality (VR) Intervention in Family Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients

Conditions

Neoplasm Caregivers Hematopoietic Stem Cell Transplantation Biobehavioral Nature Virtual Reality Stress

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background: People who receive an allogeneic hematopoietic stem cell transplant (HSCT) require long-term care at home afterwards. Their caregivers often experience high levels of stress, which can lead to symptoms such as depression, anxiety, poor sleep, fatigue, and difficulties with concentration and memory. Objective: To explore whether a nature-based immersive virtual reality (VR) program helps reduce stress in people who care for HSCT patients. Eligibility: People aged 18 and older who are primary caregivers of HSCT patients. Design: This is a two-phase study. Participants will be enrolled for 4 weeks. They will have 2 clinic visits. Participants will have a physical exam at the beginning of the study. They will be asked to provide a saliva sample in Phase 1, and saliva and blood samples in Phase 2. Participants will be given a VR headset. This is a device that looks like a pair of goggles worn over the eyes. They will be asked to wear the headset for 20 minutes per day. They will see 360 (Infinite) high-definition videos of nature and hear nature sounds. Participants will record the time they spend using the VR headset in a daily diary. They will take surveys with questions about any stress and symptoms they feel once a week. This will take up to 5 minutes. Participants will have a short regular follow-up visit by phone one week after starting their participation. At the end of the intervention study, participants will return for another physical exam. They will give saliva and/or blood samples again. Researchers will also look at the medical records of the HSCT patients; the HSCT patients must consent to this.

Official Title

A Pilot Study of a Nature-Based Virtual Reality (VR) Intervention in Family Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients

Quick Facts

Study Start:2024-06-05

Study Completion:2029-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05909202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Ability to understand and the willingness to sign a written informed consent document. 2. Age 18 years and older. 3. Serving as a primary caregiver\* for an adult patient (18 years and older) planning to undergo their 1st allogeneic HSCT at the NIH Clinical Center during the four-week study period. 4. Ability to read, speak and understand English. 5. Access to necessary resources for participating in online survey (i.e., computer, laptop, tablet, smartphone, internet access). * If more than one caregiver is planned for the transplant recipient during the transplant phase, only one primary caregiver will be eligible to participate in the study. A primary caregiver is defined as someone who lives with or provides care regularly for the HSCT recipient during the 4-week study period. Caregivers will be categorized as to whether they are the sole caregiver versus one of the multiple caregivers. 1. Ability to understand and the willingness to sign a written informed consent document. 2. Age 18 years and older. 3. Planning to undergo their 1st allogeneic HSCT at the NIH Clinical Center during the four-week study period. 4. Ability to read, speak and understand English	1. Serving as a paid caregiver for the patient. 2. Not agreeing to follow the study procedures. 3. Recent use of immersive VR programs for stress relief and/or entertainment (more than 2 days/week within the past 3 months). \* 4. Participation in another stress-reduction type interventional study within the past 3 months. 5. Having a medical condition that is prone to frequent nausea or dizziness. 6. Current or past history of seizure, chronic migraines, epilepsy, claustrophobia, panic disorder, post-traumatic stress disorder, generalized anxiety disorder, major depressive disorder or other known severe neurological or mental health disorders. 7. Being sensitive to flashing light or motion. 8. Having a balance disorder such as vertigo and cybersickness. 9. Having another medical condition or injury that may prevent use of VR headset and/or VR software (e.g., visual or hearing problems, open sores, wounds, skin rash on face, or active infection). 10. Self-reported diagnosis of Opioid, Cocaine and/or Cannabis use disorder in the past year. * In Phase II, if a participant from Sham VR group personally uses immersive VR programs for stress relief and/or entertainment (more than 2 days/week) during the study period, the participant will be no longer eligible.

Inclusion Criteria

Exclusion Criteria

1. Ability to understand and the willingness to sign a written informed consent document.
2. Age 18 years and older.
3. Serving as a primary caregiver\* for an adult patient (18 years and older) planning to undergo their 1st allogeneic HSCT at the NIH Clinical Center during the four-week study period.
4. Ability to read, speak and understand English.
5. Access to necessary resources for participating in online survey (i.e., computer, laptop, tablet, smartphone, internet access).
* If more than one caregiver is planned for the transplant recipient during the transplant phase, only one primary caregiver will be eligible to participate in the study. A primary caregiver is defined as someone who lives with or provides care regularly for the HSCT recipient during the 4-week study period. Caregivers will be categorized as to whether they are the sole caregiver versus one of the multiple caregivers.
1. Ability to understand and the willingness to sign a written informed consent document.
2. Age 18 years and older.
3. Planning to undergo their 1st allogeneic HSCT at the NIH Clinical Center during the four-week study period.
4. Ability to read, speak and understand English

1. Serving as a paid caregiver for the patient.
2. Not agreeing to follow the study procedures.
3. Recent use of immersive VR programs for stress relief and/or entertainment (more than 2 days/week within the past 3 months). \*
4. Participation in another stress-reduction type interventional study within the past 3 months.
5. Having a medical condition that is prone to frequent nausea or dizziness.
6. Current or past history of seizure, chronic migraines, epilepsy, claustrophobia, panic disorder, post-traumatic stress disorder, generalized anxiety disorder, major depressive disorder or other known severe neurological or mental health disorders.
7. Being sensitive to flashing light or motion.
8. Having a balance disorder such as vertigo and cybersickness.
9. Having another medical condition or injury that may prevent use of VR headset and/or VR software (e.g., visual or hearing problems, open sores, wounds, skin rash on face, or active infection).
10. Self-reported diagnosis of Opioid, Cocaine and/or Cannabis use disorder in the past year.
* In Phase II, if a participant from Sham VR group personally uses immersive VR programs for stress relief and/or entertainment (more than 2 days/week) during the study period, the participant will be no longer eligible.

Contacts and Locations

Study Contact

Chantal M Gerrard

CONTACT

(202) 839-7356

chantal.gerrard@nih.gov

Lena J Lee, Ph.D.

CONTACT

(301) 451-1266

jumin.park@nih.gov

Principal Investigator

Lena J Lee, Ph.D.

PRINCIPAL_INVESTIGATOR

National Institutes of Health Clinical Center (CC)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Institutes of Health Clinical Center (CC)

Lena J Lee, Ph.D., PRINCIPAL_INVESTIGATOR, National Institutes of Health Clinical Center (CC)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-05

Study Completion Date2029-09-01

Study Record Updates

Study Start Date2024-06-05

Study Completion Date2029-09-01

Terms related to this study

Keywords Provided by Researchers

Hematopoietic Stem Cell Transplantation
Biobehavioral
Nature
Virtual Reality
Stress

Additional Relevant MeSH Terms

Neoplasm
Caregivers