Breast CancerVR-PREPNCT06334380
VR for Surgical Prehabilitation and Rehabilitation
A study testing Virtual Reality Modules Only and Virtual Reality Modules + Live Physical Therapist Support in people with Breast Cancer and Frailty, run by Stanford University at 1 site in United States.
Trial summary
This randomized controlled trial aims to determine feasibility and acceptability of of VR-physical therapy modules for surgical patients undergoing breast or axilla surgery in order to prepare for and recover from surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Frailty, Surgery
- What is being tested?
- Virtual Reality Modules Only and Virtual Reality Modules + Live Physical Therapist Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2024to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18+ years of age
- English speaking
- Will undergo breast or axilla surgery at Stanford
- Have access to internet and stable Wifi at home
- Have access to a space with stable chair at home
- Ability to sit-to-stand without significant balance issues
- Absence of chronic vertigo or nausea/vomiting
- Agreeable to up to 4 weeks of prehab prior to surgery and up to 8 weeks of post-operative rehab
Who cannot join
- Inability to engage in PT due to physical limitations identified by the participant and/or care team
- Inability to complete a brief online survey at three time points during the duration of the study
- Inability to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Hospital and Clinics
Palo Alto, California, 94305
About this study
Official title: Virtual Reality for Surgical Prehabilitation and Rehabilitation
This randomized controlled trial aims to determine feasibility and acceptability of of VR-physical therapy modules for surgical patients undergoing breast or axilla surgery in order to prepare for and recover from surgery.
- Conditions
- Breast Cancer, Frailty, Surgery
- Being tested
- Virtual Reality Modules Only, Virtual Reality Modules + Live Physical Therapist Support
- Keywords
- Prehabilitation, Rehabilitation, Virtual Reality, Physical Therapy, Breast Surgery, Breast Cancer, Breast Reconstruction, Axillary Surgery
- Medical subject headings
- Breast Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Modules OnlyOther
Participants will complete self-paced VR modules prior to and after surgery (prehab/rehab) and will be provided with technical assistance from the study team.
Virtual Reality Modules + Live Physical Therapist SupportOther
Participants will complete self-paced VR modules prior to and after surgery (prehab/rehab) and will be provided with technical assistance from the study team. Participants will also have access to up to three live PT sessions via Zoom where they can ask questions and complete modules with PT feedback.
| Study group | Role | What they receive |
|---|---|---|
| Control Group: Virtual Reality Modules Only | Active comparator | Participants will have access to the prehabilitation (preoperative) and rehabilitation (postoperative) virtual reality physical therapy modules. Receives: Other: Virtual Reality Modules Only |
| Intervention Group: Virtual Reality Modules + Live Physical Therapist Support | Experimental | Participants will have access to prehabilitation and rehabilitation virtual reality physical therapy modules in addition to zoom "office hours" with the physical therapist so that they may ask questions. Receives: Other: Virtual Reality Modules + Live Physical Therapist Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
VR for remote Physical Therapy (PT)
This study will evaluate the feasibility of using VR technology to perform PT remotely from patients' homes to prepare for and recover from surgery. Frequency of engagement with the VR system (e.g., number of times participant initiated a VR physical therapy module, how long each session was used for) will be measured. Engagement with the live PT sessions will be measured.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start15 Apr 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants randomized to one of two arms, VR self-paced modules with live PT guidance and VR without live PT guidance.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cindy Kin, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334380
- Sponsor's protocol ID
- 73688
- Acronym
- VR-PREP
- Status last verified
- Apr 2024
- First submitted
- 14 Mar 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality for Surgical Prehabilitation and Rehabilitation
- ClinicalTrials.gov ID
- NCT06334380
- Acronym / sponsor ID
- VR-PREP / 73688
- Conditions
- Breast Cancer, Frailty, Surgery
- Keywords
- Prehabilitation, Rehabilitation, Virtual Reality, Physical Therapy, Breast Surgery, Breast Cancer, Breast Reconstruction, Axillary Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Mar 2024 (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.
This randomized controlled trial aims to determine feasibility and acceptability of of VR-physical therapy modules for surgical patients undergoing breast or axilla surgery in order to prepare for and recover from surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants randomized to one of two arms, VR self-paced modules with live PT guidance and VR without live PT guidance.
| Arm | Type | Receives |
|---|---|---|
| Control Group: Virtual Reality Modules Only | Active comparator | Other: Virtual Reality Modules OnlyParticipants will have access to the prehabilitation (preoperative) and rehabilitation (postoperative) virtual reality physical therapy modules. |
| Intervention Group: Virtual Reality Modules + Live Physical Therapist Support | Experimental | Other: Virtual Reality Modules + Live Physical Therapist SupportParticipants will have access to prehabilitation and rehabilitation virtual reality physical therapy modules in addition to zoom "office hours" with the physical therapist so that they may ask questions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18+ years of age
- English speaking
- Will undergo breast or axilla surgery at Stanford
- Have access to internet and stable Wifi at home
- Have access to a space with stable chair at home
Key exclusion criteria (3 listed)
- Inability to engage in PT due to physical limitations identified by the participant and/or care team
- Inability to complete a brief online survey at three time points during the duration of the study
- Inability to consent
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 |
|---|---|---|
| Virtual Reality Modules OnlyParticipants will complete self-paced VR modules prior to and after surgery (prehab/rehab) and will be provided with technical assistance from the study team. | Other | Control Group: Virtual Reality Modules Only |
| Virtual Reality Modules + Live Physical Therapist SupportParticipants will complete self-paced VR modules prior to and after surgery (prehab/rehab) and will be provided with technical assistance from the study team. Participants will also have access to up to three live PT sessions via Zoom where they can ask questions and complete modules with PT feedback. | Other | Intervention Group: Virtual Reality Modules + Live Physical Therapist Support |
Primary outcome
VR for remote Physical Therapy (PT)
Time frame: 12 weeks
This study will evaluate the feasibility of using VR technology to perform PT remotely from patients' homes to prepare for and recover from surgery. Frequency of engagement with the VR system (e.g., number of times participant initiated a VR physical therapy module, how long each session was used for) will be measured. Engagement with the live PT sessions will be measured.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Modules Only and Virtual Reality Modules + Live Physical Therapist Support in people with Breast Cancer and Frailty, run by Stanford University 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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Apr 2024. 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. 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?
Results are not available in the source record.
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?
VR for remote Physical Therapy (PT) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2024.