NeoplasmNCT05909202
A Nature-Based Virtual Reality (VR) Intervention in Family Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients
A study testing Active VR in people with Neoplasm and Caregivers, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Neoplasm, Caregivers
- What is being tested?
- Active VR
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2024to 27 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caregiver subjects
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Ability to understand and the willingness to sign a written informed consent document.
- Age 18 years and older.
- 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.
- Ability to read, speak and understand English.
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- 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.
- HSCT recipient subjects
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Ability to understand and the willingness to sign a written informed consent document.
- Age 18 years and older.
- Planning to undergo their 1st allogeneic HSCT at the NIH Clinical Center during the four-week study period.
- Ability to read, speak and understand English
Who cannot join
- Caregiver subjects
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Serving as a paid caregiver for the patient.
- Not agreeing to follow the study procedures.
- Recent use of immersive VR programs for stress relief and/or entertainment (more than 2 days/week within the past 3 months). *
- Participation in another stress-reduction type interventional study within the past 3 months.
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- Having a medical condition that is prone to frequent nausea or dizziness.
- 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.
- Being sensitive to flashing light or motion.
- Having a balance disorder such as vertigo and cybersickness.
- 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).
- 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.
- HSCT recipient subjects:
- 1. Not agreeing to follow the study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Pilot Study of a Nature-Based Virtual Reality (VR) Intervention in Family Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients
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.
Read more
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....
Read the detailed description
Study Description:
This is an interventional protocol to decrease stress and symptoms with a four-week nature-based VR intervention in family caregivers of allogeneic HSCT recipients. This study is a two-phase study: Phase I will be a single-arm pre-post design focused on assessing the feasibility and acceptability of the four-week nature-based immersive VR program. Phase II will be a prospective randomized controlled group design to examine the effectiveness of the four-week nature-based immersive VR program (Active VR) on stress and symptoms compared to a four-week nature-based non-immersive VR program (Sham VR) in the target population.
Objectives:
Phase I
Primary Objective: To evaluate the feasibility and acceptability of the nature-based immersive VR program in HSCT caregivers.
Secondary Objectives: To examine the level of perceived restorativeness, perceived stress, and symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment) in HSCT caregivers participating in the nature-based immersive VR program.
Exploratory Objectives: To examine relationships among variables including but not limited to perceived stress, symptoms, HSCT caregiver characteristics, HSCT recipient characteristics, and biomarkers.
Phase II
Primary Objective: To examine whether HSCT caregivers participating in Active VR demonstrate improved levels of perceived stress compared to those participating in Sham VR.
Secondary Objectives:
- To examine whether HSCT caregivers participating in Active VR demonstrate improved levels of symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment) compared to those participating in Sham VR.
- To examine the acceptability of Active and Sham VR programs in HSCT caregivers.
Exploratory Objectives: To examine relationships among variables including but not limited to perceived stress, symptoms, HSCT caregiver characteristics, HSCT recipient characteristics, and biomarkers.
Endpoints: Phase I
Primary Endpoints: Feasibility (recruitment, retention, and adherence rates) and acceptability (satisfaction, usability) measured at Time 4 (Day 28); acceptability (safety) from Time 0 (Baseline; Day 0) to Time 4
Secondary Endpoints: Perceived restorativeness measured at Time 4; changes in perceived stress from Time 0 to Time 4; changes in symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment) from Time 0 to Time 4
Phase II
Primary Endpoint: Changes in perceived stress from Time 0 to Time 4
Secondary Endpoints: Changes in symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment) from Time 0 to Time 4; acceptability (satisfaction, usability) measured at Time 4; acceptability (safety) from Time 0 to Time 4
- Conditions
- Neoplasm, Caregivers
- Being tested
- Sham VR, Active VR
- Keywords
- Hematopoietic Stem Cell Transplantation, Biobehavioral, Nature, Virtual Reality, Stress
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham VRDevice
Nature-based non-immersive VR program
Active VRDevice
Nature-based immersive VR program
| Study group | Role | What they receive |
|---|---|---|
| Active VR Group | Experimental | Nature-based immersive VR program, completion of questionnaires, and saliva and blood sample submission. Receives: Device: Active VR |
| Sham VR Group | Sham comparator | Nature-based non-immersive VR program, completion of questionnaires, and saliva and blood sample submission. Receives: Device: Sham VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in perceived stress
The outcome will be used to assess the effects of the Active VR compared to the Sham VR.
Measured: 4 weeks
Secondary outcomes (1)
Changes in symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment), acceptability (satisfaction, usability), acceptability (safety) (Cross) (Cross) (Cross)
The outcome will be used to assess the effects of the Active VR compared to the Sham VR.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start5 Jun 2024
- Primary completion27 Feb 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lena J Lee, Ph.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909202
- Sponsor's protocol ID
- 10001636
- Other IDs
- 001636-CC
- Status last verified
- 8 Apr 2026
- First submitted
- 16 Jun 2023
- Last updated
- 20 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee LJ, Son EH, Farmer N, Gerrard C, Tuason RT, Yang L, Kohn-Godbout J, Stephens C, Nahm ES, Smith L, Risch S, Wallen GR. Nature-based virtual reality intervention to manage stress in family caregivers of allogeneic hematopoietic stem cell transplant recipients: a two-phase pilot study protocol. Front Psychiatry. 2024 Mar 7;15:1295097. doi: 10.3389/fpsyt.2024.1295097. eCollection 2024.
PubMed 38516258
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Nature-Based Virtual Reality (VR) Intervention in Family Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients
- ClinicalTrials.gov ID
- NCT05909202
- Acronym / sponsor ID
- 10001636
- Conditions
- Neoplasm, Caregivers
- Keywords
- Hematopoietic Stem Cell Transplantation, Biobehavioral, Nature, Virtual Reality, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
Detailed description
Study Description:
This is an interventional protocol to decrease stress and symptoms with a four-week nature-based VR intervention in family caregivers of allogeneic HSCT recipients. This study is a two-phase study: Phase I will be a single-arm pre-post design focused on assessing the feasibility and acceptability of the four-week nature-based immersive VR program. Phase II will be a prospective randomized controlled group design to examine the effectiveness of the four-week nature-based immersive VR program (Active VR) on stress and symptoms compared to a four-week nature-based non-immersive VR program (Sham VR) in the target population.
Objectives:
Phase I
Primary Objective: To evaluate the feasibility and acceptability of the nature-based immersive VR program in HSCT caregivers.
Secondary Objectives: To examine the level of perceived restorativeness, perceived stress, and symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment) in HSCT caregivers participating in the nature-based immersive VR program.
Exploratory Objectives: To examine relationships among variables including but not limited to perceived stress, symptoms, HSCT caregiver characteristics, HSCT recipient characteristics, and biomarkers.
Phase II
Primary Objective: To examine whether HSCT caregivers participating in Active VR demonstrate improved levels of perceived stress compared to those participating in Sham VR.
Secondary Objectives:
- To examine whether HSCT caregivers participating in Active VR demonstrate improved levels of symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment) compared to those participating in Sham VR.
- To examine the acceptability of Active and Sham VR programs in HSCT caregivers.
Exploratory Objectives: To examine relationships among variables including but not limited to perceived stress, symptoms, HSCT caregiver characteristics, HSCT recipient characteristics, and biomarkers.
Endpoints: Phase I
Primary Endpoints: Feasibility (recruitment, retention, and adherence rates) and acceptability (satisfaction, usability) measured at Time 4 (Day 28); acceptability (safety) from Time 0 (Baseline; Day 0) to Time 4
Secondary Endpoints: Perceived restorativeness measured at Time 4; changes in perceived stress from Time 0 to Time 4; changes in symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment) from Time 0 to Time 4
Phase II
Primary Endpoint: Changes in perceived stress from Time 0 to Time 4
Secondary Endpoints: Changes in symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment) from Time 0 to Time 4; acceptability (satisfaction, usability) measured at Time 4; acceptability (safety) from Time 0 to Time 4
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active VR Group | Experimental | Device: Active VRNature-based immersive VR program, completion of questionnaires, and saliva and blood sample submission. |
| Sham VR Group | Sham comparator | Device: Sham VRNature-based non-immersive VR program, completion of questionnaires, and saliva and blood sample submission. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Caregiver subjects
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Ability to understand and the willingness to sign a written informed consent document.
- Age 18 years and older.
- 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.
Key exclusion criteria (15 listed)
- Caregiver subjects
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Serving as a paid caregiver for the patient.
- Not agreeing to follow the study procedures.
- Recent use of immersive VR programs for stress relief and/or entertainment (more than 2 days/week within the past 3 months). *
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham VRNature-based non-immersive VR program | Device | Sham VR Group |
| Active VRNature-based immersive VR program | Device | Active VR Group |
Primary outcome
Changes in perceived stress
Time frame: 4 weeks
The outcome will be used to assess the effects of the Active VR compared to the Sham VR.
1 secondary outcome
Changes in symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment), acceptability (satisfaction, usability), acceptability (safety) (Cross) (Cross) (Cross)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Derived from this study: PubMed 38516258Lee LJ, Son EH, Farmer N, Gerrard C, Tuason RT, Yang L, Kohn-Godbout J, Stephens C, Nahm ES, Smith L, Risch S, Wallen GR. Nature-based virtual reality intervention to manage stress in family caregivers of allogeneic hematopoietic stem cell transplant recipients: a two-phase pilot study protocol. Front Psychiatry. 2024 Mar 7;15:1295097. doi: 10.3389/fpsyt.2024.1295097. eCollection 2024.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena J Lee, Ph.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active VR in people with Neoplasm and Caregivers, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in perceived stress (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05909202, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.