Breast CancerCog-RVNCT06267014
Use of a Virtual Reality Cognitive Stimulation Programme for Breast Cancer Patients Wishing to Restart or Maintain a Professional Activity
A study testing Virtual Reality sessions in people with Breast Cancer and Cancer-related Cognitive Difficulties, run by Centre Francois Baclesse at 1 site in France.
Trial summary
The study concerns patients who have been treated for breast cancer, have cognitive problems and are planning to return to work or are currently working and wish to begin cognitive rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Cancer-related Cognitive Difficulties
- What is being tested?
- Virtual Reality sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2024to 6 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients >18 years of age
- Patient with breast cancer for whom adjuvant chemotherapy has been administered; maintenance treatments (e.g. Trastuzumab, hormone therapy) are eligible,
- Maximum 2 years after completion of adjuvant treatment,
- Patients who have cognitive complaints at inclusion (answer yes to the question: 'Since your cancer treatment, have you had any difficulties with memory, concentration, etc.?)
- Patients planning to return to work or who have returned to work in the past year,
- Signature of informed consent prior to any specific procedure relating to the study,
- Patient affiliated to a social security system.
Who cannot join
- Patients suffering from illnesses or conditions that impair their ability to understand, follow and/or comply with study procedures,
- Patients with personality disorders and/or psychiatric pathology,
- Patients deprived of their liberty or placed under the authority of a guardian,
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
The study concerns patients who have been treated for breast cancer, have cognitive problems and are planning to return to work or are currently working and wish to begin cognitive rehabilitation.
Patients will follow the Virtual Reality program developed for the study, during the cognitive rehabilitation usually proposed in the establishment, at the rate of a weekly session of 10-15 minute for 6 weeks.
- Being tested
- Virtual Reality sessions
- Keywords
- virtual reality, cognitive rehabilitation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality sessionsBehavioural
One session during 10-15 minutes per week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality sessions | Experimental | Not described Receives: Behavioral: Virtual Reality sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients adhering to the Virtual Reality program
Adherence is defined as the completion of at least 5 of the 6 sessions planned.
Measured: At 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start23 May 2024
- Primary completion6 Feb 2026
- Study completion6 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 Breast CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will follow the Virtual Reality program developed for the study, during the cognitive rehabilitation sessions
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267014
- Sponsor's protocol ID
- 2023-A02163-42
- Acronym
- Cog-RV
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2024
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vieira Jales I, Hummel E, Clarisse B, Gouranton V, Cogne M, Lecuyer A, Leconte A, Lequesne J, Ahmed-Lecheheb D, Morel A, Fernette M, Joly F, Lange M. Virtual reality-based cognitive rehabilitation programme to support employment in patients with breast cancer: protocol for the Cog-RV pilot study. BMJ Open. 2025 Dec 15;15(12):e112196. doi: 10.1136/bmjopen-2025-112196.
PubMed 41401994
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Virtual Reality Cognitive Stimulation Programme for Breast Cancer Patients Wishing to Restart or Maintain a Professional Activity
- ClinicalTrials.gov ID
- NCT06267014
- Acronym / sponsor ID
- Cog-RV / 2023-A02163-42
- Keywords
- virtual reality, cognitive rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 23 May 2024 (actual)
- Primary completion
- 6 Feb 2026 (actual)
- Study completion
- 6 Feb 2026 (actual)
- First posted
- 20 Feb 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.
The study concerns patients who have been treated for breast cancer, have cognitive problems and are planning to return to work or are currently working and wish to begin cognitive rehabilitation.
Patients will follow the Virtual Reality program developed for the study, during the cognitive rehabilitation usually proposed in the establishment, at the rate of a weekly session of 10-15 minute for 6 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will follow the Virtual Reality program developed for the study, during the cognitive rehabilitation sessions
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality sessions | Experimental | Behavioral: Virtual Reality sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients >18 years of age
- Patient with breast cancer for whom adjuvant chemotherapy has been administered; maintenance treatments (e.g. Trastuzumab, hormone therapy) are eligible,
- Maximum 2 years after completion of adjuvant treatment,
- Patients who have cognitive complaints at inclusion (answer yes to the question: 'Since your cancer treatment, have you had any difficulties with memory, concentration, etc.?)
- Patients planning to return to work or who have returned to work in the past year,
Key exclusion criteria (4 listed)
- Patients suffering from illnesses or conditions that impair their ability to understand, follow and/or comply with study procedures,
- Patients with personality disorders and/or psychiatric pathology,
- Patients deprived of their liberty or placed under the authority of a guardian,
- Pregnant women
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 sessionsOne session during 10-15 minutes per week for 6 weeks. | Behavioural | Virtual Reality sessions |
Primary outcome
Proportion of patients adhering to the Virtual Reality program
Time frame: At 6 weeks
Adherence is defined as the completion of at least 5 of the 6 sessions planned.
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 10 Feb 2026.
- Derived from this study: PubMed 41401994Vieira Jales I, Hummel E, Clarisse B, Gouranton V, Cogne M, Lecuyer A, Leconte A, Lequesne J, Ahmed-Lecheheb D, Morel A, Fernette M, Joly F, Lange M. Virtual reality-based cognitive rehabilitation programme to support employment in patients with breast cancer: protocol for the Cog-RV pilot study. BMJ Open. 2025 Dec 15;15(12):e112196. doi: 10.1136/bmjopen-2025-112196.
- 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 sessions in people with Breast Cancer and Cancer-related Cognitive Difficulties, run by Centre Francois Baclesse at 1 site in France.
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 7 inclusion and 4 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 10 Feb 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 France. 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?
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?
Proportion of patients adhering to the Virtual Reality program (time frame: At 6 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 NCT06267014, 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 10 Feb 2026.