Brain CancerNCT07313709
Measuring the Feasibility and Effect of a Virtual Reality Cognitive Training Intervention for Brain Cancer Survivors.
A study testing Virtual Reality System and Word Search Puzzles in people with Brain Cancer, run by University of Cincinnati at 1 site in United States.
Trial summary
The study is focused on assessing the feasibility and effect of a virtual reality training intervention for improving the survivorship journey of brain cancer survivors, post-treatment. The gaming intervention is intended to reduce cognitive impairment, while increasing well-being, mental health, and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer
- What is being tested?
- Virtual Reality System and Word Search Puzzles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Low grade glioma survivors.
- Have mild cognitive impairment (MCI) per MoCA (defined as any score between 18 and 25).
- Completed all cancer treatment for their low-grade glioma (including chemotherapy, immunotherapy, radiation therapy and surgical procedures) and are now >30 days to 24 months from the date of last treatment.
- Age 18 years or older.
- English speaking.
- Able to provide consent without use of a Legally Authorized Representative
- Available to play the VR game or complete word search puzzles once per day for six days per week for four consecutive weeks in their home (per patient self-report).
- Have a reliable phone number by which they can be reached to make arrangement for testing and for follow-up calls.
Who cannot join
- 1. History of serious mental or severe psychiatric illnesses (e.g., bi-polar disorder, schizophrenia etc....).
- Note: Anxiety or depression are not exclusionary. 2. History or known neurodegenerative diseases such as Alzheimer's disease, vascular dementia or any other form of advanced neurodegenerative or neuro-cognitive diseases.
- 3. History of drug intoxication/overdose (addiction history). 4. History of acute traumatic brain injury. 5. History of stroke causing a cognitive deficit only. 6. Vision impairments including legal blindness.
- Note: patients with corrected vision (e.g., glasses or contacts) or who are color-blind are eligible.
- 7. Incarcerated at the time of study enrollment. 8. Enrolled in another clinical trial which does not permit co-enrollment. 9. Any medical condition precluding safe use of VR headset and hand control technology, including patients with medical devices, including cardiac pacemakers, hearing aids/cochlear implants and defibrillators.
- 10. History of motion sickness per patient self-report.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anthony Faiola, PhD contact
United States1 site
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
UCCC CTO, 513-584-7698, cancer@uchealth.com
Anthony Faiola, PhD
About this study
The study is focused on assessing the feasibility and effect of a virtual reality training intervention for improving the survivorship journey of brain cancer survivors, post-treatment. The gaming intervention is intended to reduce cognitive impairment, while increasing well-being, mental health, and quality of life.
Read the detailed description
This study is focused on assessing the feasibility, acceptability and effect of a virtual reality training intervention for improving the survivorship journey of brain cancer survivors, post-treatment. The gaming intervention is intended to reduce cognitive impairment, while increasing well-being, mental health, and quality of life. In sum, the potential impact of this research is to realize the capability of virtual reality cognitive rehabilitation training (VR-CRT) by mitigating brain cancer survivors (BCS) cognitive decline, while improving overall quality of life (QOL).
- Conditions
- Brain Cancer
- Being tested
- Virtual Reality System, Word Search Puzzles
- Keywords
- virtual reality, cognitive impairment, brain cancer, cancer survivorship, non-invasive therapeutic medicine
- Medical subject headings
- Brain Neoplasms, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality SystemOther
Participants randomized to using VR-CRT will have the game already installed/uploaded in the VR headset and ready for use, with their pre-determined participant number for user login and password assigned.
Word Search PuzzlesOther
Participants randomized to the control group will have their WSP packet with pre-selected word puzzles that provide a cognitive stimulus but without an increase in complexity. The instructions provided will state how participants should complete the WSP day-by-day. The dated completed WSPs, along with weekly check-ins by the study CRC will constitute the record for the participant's progress over four weeks. CRCs will notify the PI via email if during the call the participant indicates they have missed any of the WSPs during a given week.
| Study group | Role | What they receive |
|---|---|---|
| Experimental (Virtual Reality - VR) | Experimental | Experimental (VR) Participants ONLY:
Participants randomized to using Virtual Reality-Cognitive Rehab Training (VR-CRT) will have the game already installed/uploaded in the VR headset and ready for use, with their pre-determined participant number for user login and password assigned. Receives: Other: Virtual Reality System |
| Control (WSP) | Active comparator | Control (WSP) Participants ONLY:
Participants randomized to the control group will have their WSP packet with pre-selected word puzzles that provide a cognitive stimulus but without an increase in complexity. The instructions provided will state how participants should complete the WSP day-by-day. The dated completed WSPs, along with weekly check-ins by the study CRC will constitute the record for the participant's progress over four weeks. CRCs will notify the PI via email if during the call the participant indicates they have missed any of the WSPs during a given week. Receives: Other: Word Search Puzzles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility defined as >80% (> 16 participants out of 20) able to complete the experimental arm study in 4 weeks.
FEASIBILITY: Measure the feasibility of using VR-CRT and Control (i.e., paper-based Word-search puzzles (WSP)) with brain cancer survivors (BCS) experiencing cancer-related cognitive impairment (CRCI).
Feasibility: will be defined as >80% (> 16 participants out of 20) able to complete the experimental arm study in 4 weeks. Since the standard/control arm is well established and routine, feasibility evaluation is not required in this arm. (If subjects withdraw in disproportion in two arms after the randomization, the study may be suspended for further evaluation.)
Measured: 4 weeks
Acceptability defined as scores of >8 on each subscale of the Senior Technology Acceptance Model (STAM).54 The STAM (Short Version) measures four attitudes towards technology on a Likert scale of 1-10.
ACCEPTABILITY: Measure the acceptability of using VR-CRT and Control (i.e., paper-based Word-search puzzles (WSP)) with brain cancer survivors (BCS) experiencing cancer-related cognitive impairment (CRCI). Acceptability: will be defined as scores of >8 on each subscale of the Senior Technology Acceptance Model (STAM).54 The STAM (Short Version) measures four attitudes towards technology on a Likert scale of 1-10. (See sections 3.1, 17.1 for detail.) This score of >8 for all 14 responses will be calculated as an average of all of the completed sub-scales per each subject. Any missing sub-scales (non-response by subjects) will not be considered into the calculation of the mean per subject. The score of >8 must be observed in >80% (>32 participants) to be considered acceptable.
Measured: 4 weeks
Effect of VR-CRT (and Control) on cognitive function measured by scores at baseline and post-intervention,using 1.) Hopkins Verbal Learning Test
EFFECT: Estimate the effect of VR-CRT (and Control) on brain cancer survivors' cognitive function such as memory, attention/focus, processing speed, and executive function. Effect: will be measured by 1.) Hopkins Verbal Learning Test (HVLT)
Measured: 4 weeks
Effect of VR-CRT (and Control) on cognitive function measured by scores at baseline and post-intervention,using 2.) Controlled Oral Word Association
EFFECT: Estimate the effect of VR-CRT (and Control) on brain cancer survivors' cognitive function such as memory, attention/focus, processing speed, and executive function. Effect: will be measured by comparing scores collected at baseline and post-intervention, (i.e., at the conclusion of a four-week intervention period) using 2.) Controlled Oral Word Association (COWA)
Measured: 4 weeks
Effect of VR-CRT (and Control) on cognitive function measured by scores at baseline and post-intervention,using 3.) Trail Making A-B
EFFECT: Estimate the effect of VR-CRT (and Control) on brain cancer survivors' cognitive function such as memory, attention/focus, processing speed, and executive function. Effect: will be measured by comparing scores collected at baseline and post-intervention, (i.e., at the conclusion of a four-week intervention period) using 3.) Trail Making A-B (TMa/b).
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 posted2 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After eligibility is confirmed, participants will be randomized into either the Experimental (Virtual Reality) or Control (Word Search Puzzles) Arms. Participants will be randomized in blocks of 4 through a computer-generated randomization such that the final n in the experimental arm is 20 and the control arm is 20. If a participant has to drop out of the study for any reason after randomization and start of the baseline/onboarding phase (e.g., due to motion sickness during participation) this will be considered in the assessment of feasibility for this study and they will not be replaced. The UCCC Data Manager will issue subject randomization to the study team upon receipt of confirmation of eligibility (with eligibility being confirmed per UCCC CTO workflows).
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Faiola, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313709
- Sponsor's protocol ID
- UCCC-BN-25-01
- Status last verified
- Oct 2025
- First submitted
- 29 Oct 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Feasibility and Effect of a Virtual Reality Cognitive Training Intervention for Brain Cancer Survivors.
- ClinicalTrials.gov ID
- NCT07313709
- Acronym / sponsor ID
- UCCC-BN-25-01
- Conditions
- Brain Cancer
- Keywords
- virtual reality, cognitive impairment, brain cancer, cancer survivorship, non-invasive therapeutic medicine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 2 Jan 2026 (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.
The study is focused on assessing the feasibility and effect of a virtual reality training intervention for improving the survivorship journey of brain cancer survivors, post-treatment. The gaming intervention is intended to reduce cognitive impairment, while increasing well-being, mental health, and quality of life.
Detailed description
This study is focused on assessing the feasibility, acceptability and effect of a virtual reality training intervention for improving the survivorship journey of brain cancer survivors, post-treatment. The gaming intervention is intended to reduce cognitive impairment, while increasing well-being, mental health, and quality of life. In sum, the potential impact of this research is to realize the capability of virtual reality cognitive rehabilitation training (VR-CRT) by mitigating brain cancer survivors (BCS) cognitive decline, while improving overall quality of life (QOL).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After eligibility is confirmed, participants will be randomized into either the Experimental (Virtual Reality) or Control (Word Search Puzzles) Arms. Participants will be randomized in blocks of 4 through a computer-generated randomization such that the final n in the experimental arm is 20 and the control arm is 20. If a participant has to drop out of the study for any reason after randomization and start of the baseline/onboarding phase (e.g., due to motion sickness during participation) this will be considered in the assessment of feasibility for this study and they will not be replaced. The UCCC Data Manager will issue subject randomization to the study team upon receipt of confirmation of eligibility (with eligibility being confirmed per UCCC CTO workflows).
| Arm | Type | Receives |
|---|---|---|
| Experimental (Virtual Reality - VR) | Experimental | Other: Virtual Reality SystemExperimental (VR) Participants ONLY: Participants randomized to using Virtual Reality-Cognitive Rehab Training (VR-CRT) will have the game already installed/uploaded in the VR headset and ready for use, with their pre-determined participant number for user login and password assigned. |
| Control (WSP) | Active comparator | Other: Word Search PuzzlesControl (WSP) Participants ONLY: Participants randomized to the control group will have their WSP packet with pre-selected word puzzles that provide a cognitive stimulus but without an increase in complexity. The instructions provided will state how participants should complete the WSP day-by-day. The dated completed WSPs, along with weekly check-ins by the study CRC will constitute the record for the participant's progress over four weeks. CRCs will notify the PI via email if during the call the participant indicates they have missed any of the WSPs during a given week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Low grade glioma survivors.
- Have mild cognitive impairment (MCI) per MoCA (defined as any score between 18 and 25).
- Completed all cancer treatment for their low-grade glioma (including chemotherapy, immunotherapy, radiation therapy and surgical procedures) and are now >30 days to 24 months from the date of last treatment.
- Age 18 years or older.
- English speaking.
Key exclusion criteria (6 listed)
- 1. History of serious mental or severe psychiatric illnesses (e.g., bi-polar disorder, schizophrenia etc....).
- 3. History of drug intoxication/overdose (addiction history). 4. History of acute traumatic brain injury. 5. History of stroke causing a cognitive deficit only. 6. Vision impairments including legal blindness.
- 7. Incarcerated at the time of study enrollment. 8. Enrolled in another clinical trial which does not permit co-enrollment. 9. Any medical condition precluding safe use of VR headset and hand control technology, including patients with medical devices, including cardiac pacemakers, hearing aids/cochlear implants and defibrillators.
- 10. History of motion sickness per patient self-report.
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 SystemParticipants randomized to using VR-CRT will have the game already installed/uploaded in the VR headset and ready for use, with their pre-determined participant number for user login and password assigned. | Other | Experimental (Virtual Reality - VR) |
| Word Search PuzzlesParticipants randomized to the control group will have their WSP packet with pre-selected word puzzles that provide a cognitive stimulus but without an increase in complexity. The instructions provided will state how participants should complete the WSP day-by-day. The dated completed WSPs, along with weekly check-ins by the study CRC will constitute the record for the participant's progress over four weeks. CRCs will notify the PI via email if during the call the participant indicates they have missed any of the WSPs during a given week. | Other | Control (WSP) |
Primary outcome
Feasibility defined as >80% (> 16 participants out of 20) able to complete the experimental arm study in 4 weeks.
Time frame: 4 weeks
FEASIBILITY: Measure the feasibility of using VR-CRT and Control (i.e., paper-based Word-search puzzles (WSP)) with brain cancer survivors (BCS) experiencing cancer-related cognitive impairment (CRCI). Feasibility: will be defined as >80% (> 16 participants out of 20) able to complete the experimental arm study in 4 weeks. Since the standard/control arm is well established and routine, feasibility evaluation is not required in this arm. (If subjects withdraw in disproportion in two arms after the randomization, the study may be suspended for further evaluation.)
Acceptability defined as scores of >8 on each subscale of the Senior Technology Acceptance Model (STAM).54 The STAM (Short Version) measures four attitudes towards technology on a Likert scale of 1-10.
Time frame: 4 weeks
ACCEPTABILITY: Measure the acceptability of using VR-CRT and Control (i.e., paper-based Word-search puzzles (WSP)) with brain cancer survivors (BCS) experiencing cancer-related cognitive impairment (CRCI). Acceptability: will be defined as scores of >8 on each subscale of the Senior Technology Acceptance Model (STAM).54 The STAM (Short Version) measures four attitudes towards technology on a Likert scale of 1-10. (See sections 3.1, 17.1 for detail.) This score of >8 for all 14 responses will be calculated as an average of all of the completed sub-scales per each subject. Any missing sub-scales (non-response by subjects) will not be considered into the calculation of the mean per subject. The score of >8 must be observed in >80% (>32 participants) to be considered acceptable.
Effect of VR-CRT (and Control) on cognitive function measured by scores at baseline and post-intervention,using 1.) Hopkins Verbal Learning Test
Time frame: 4 weeks
EFFECT: Estimate the effect of VR-CRT (and Control) on brain cancer survivors' cognitive function such as memory, attention/focus, processing speed, and executive function. Effect: will be measured by 1.) Hopkins Verbal Learning Test (HVLT)
Effect of VR-CRT (and Control) on cognitive function measured by scores at baseline and post-intervention,using 2.) Controlled Oral Word Association
Time frame: 4 weeks
EFFECT: Estimate the effect of VR-CRT (and Control) on brain cancer survivors' cognitive function such as memory, attention/focus, processing speed, and executive function. Effect: will be measured by comparing scores collected at baseline and post-intervention, (i.e., at the conclusion of a four-week intervention period) using 2.) Controlled Oral Word Association (COWA)
Effect of VR-CRT (and Control) on cognitive function measured by scores at baseline and post-intervention,using 3.) Trail Making A-B
Time frame: 4 weeks
EFFECT: Estimate the effect of VR-CRT (and Control) on brain cancer survivors' cognitive function such as memory, attention/focus, processing speed, and executive function. Effect: will be measured by comparing scores collected at baseline and post-intervention, (i.e., at the conclusion of a four-week intervention period) using 3.) Trail Making A-B (TMa/b).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Brain Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Active, not recruitingPhase 3
Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM
Glioblastoma, Recurrent Glioblastoma
RecruitingObservational study
Tumor Related Epilepsy
Epilepsy, Cancer
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
RecruitingPhase 2/3
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
HER2-positive Breast Cancer
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.
Anthony Faiola, PhD contact
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 System and Word Search Puzzles in people with Brain Cancer, run by University of Cincinnati 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 6 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: opening soon, as of the sponsor's last update on 2 Jan 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact UCCC Clinical Trials Office (513-584-7698, cancer@uchealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility defined as >80% (> 16 participants out of 20) able to complete the experimental arm study in 4 weeks. (time frame: 4 weeks). The study lists 5 primary outcomes in all. 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 2 Jan 2026.