Breast CancerVRtuose1NCT06305117
Virtual RealiTy and mUsic in the Oncology SEtting - Phase 1
A study testing Distraction strategy in people with Breast Cancer, run by International Agency for Research on Cancer at 1 site in France.
Trial summary
The VRtuose (Virtual RealiTy and mUsic in the Oncology Setting) project aims to evaluate the feasibility of implementing in day patient chemotherapy units a distraction strategy combining virtual reality (VR) and music which fits the needs of both breast cancer patients and healthcare providers (i.e., strategy… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Distraction strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2024to 29 Sep 2025
- 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
- Histologically confirmed diagnosis of breast cancer;
- Any disease stage;
- Patient must be receiving (i.e., with at least 4 remaining cures) or about to start palliative or curative neoadjuvant or adjuvant chemotherapy for their breast cancer at Centre Léon Bérard;
- Willingness and ability to comply with the study requirements;
- Patient must be covered by a medical insurance;
- Patient must understand, speak, read and write French.
Who cannot join
- History of condition contraindicating the use of virtual reality (e.g., epilepsy, severe motion sickness);
- Brain metastases;
- Any medical or psychosocial condition that would compromise the patient's compliance to the study procedures or would likely interfere with the completion of Patient-Reported Outcomes;
- Patients under tutorship or curatorship;
- Patients already included in another clinical trial ongoing at Centre Léon Bérard.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VRtuose (Virtual RealiTy and mUsic in the Oncology SEtting) : A Single-centre Feasibility Study Evaluating a Strategy Combining Virtual Reality and Music to Improve Quality of Life in Breast Cancer Patients Undergoing Chemotherapy
The VRtuose (Virtual RealiTy and mUsic in the Oncology Setting) project aims to evaluate the feasibility of implementing in day patient chemotherapy units a distraction strategy combining virtual reality (VR) and music which fits the needs of both breast cancer patients and healthcare providers (i.e., strategy administrators), and to evaluate its impact on patients' (i) perceived anxiety and pain during chemotherapy sessions, (ii) nausea/vomiting and mood disturbances in between chemotherapy sessions, and (iii) quality of life.
The present project is a non-randomized non-controlled prospective monocentric feasibility study which will focus on evaluating the feasibility of implementing the strategy in the target population and setting.
In the case that implementation of a distraction strategy combining virtual reality and music to improve quality of life of breast cancer patients during chemotherapy is deemed feasible, the efficacy of using this strategy to improve patients' experience of chemotherapy and long-term quality of life will be evaluated in a future randomized controlled trial informed and optimized by the results of the present work.
Read the detailed description
VRtuose (phase 1) is a non-randomized, single-centre, prospective, feasibility study conducted in the day patient chemotherapy unit of the Centre Léon Bérard in Lyon. This study will include women diagnosed with breast cancer who are receiving or are planned to receive any chemotherapy regimen. As this is a feasibility study, there will be no control group and all participants will be offered the intervention.
The intervention will be implemented from the first chemotherapy session onwards until it has been offered at four distinct chemotherapy sessions or until the end of patients' chemotherapy course if it is ended earlier. The intervention will be offered in addition to the standard of care at the study hospital.
All women with breast cancer who are about to start or who have started chemotherapy will be considered for inclusion in the study. All participants will be offered the distraction strategy for four consecutive chemotherapy sessions spanning over their chemotherapy course (i.e., from the first session onwards) whenever the strategy is available for use.
The intervention will be characterised by a strategy combining immersive virtual reality and music delivered during chemotherapy sessions to breast cancer patients by trained oncology nurses. Different immersive environments and of music will be available to the choice of the patient. From the first chemotherapy session onwards, patients will be offered by oncology nurses to use the distraction strategy during their chemotherapy session. Patients who are willing to use the strategy will have the possibility to choose the content of the strategy and to use it for the duration of their choice. Patients will be followed up from recruitment until they have been offered four times to use the strategy (or until the end of their chemotherapy course if it ends earlier).
This study will assess the feasibility to implement such a strategy into a day-hospital chemotherapy unit at a major oncology centre, and will therefore collect information on feasibility, acceptability and tolerability outcomes of using the strategy in this context. The efficacy of the strategy to improve patients' quality of life will not be evaluated in this study.
- Conditions
- Breast Cancer
- Being tested
- Distraction strategy
- Keywords
- quality of life, virtual reality, music, feasibility study
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distraction strategyOther
Distraction strategy combining the use of virtual reality and music
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | As this is a feasibility study, all patients included in this study will be offered the intervention. Receives: Other: Distraction strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' acceptance rate regarding the use of the distraction strategy.
Average of the number of times the strategy is used by each patient out of the number of chemotherapy cures it is offered to each patient.
Measured: Through study completion, an average of 8 months.
Secondary outcomes (13)
Accessibility of the strategy
Percentage of chemotherapy sessions when strategy administrators offer patients to use the strategy.
Measured: Through study completion, an average of 8 months.
Duration of use of the strategy by patients
Time elapsed in between start of the first video and end of the last video watched by the participant.
Measured: Through study completion, an average of 8 months.
Type of video content chosen by participants
Measured using a questionnaire
Measured: Through study completion, an average of 8 months.
Type of music content chosen by participants
Measured using a questionnaire
Measured: Through study completion, an average of 8 months.
Patients' perception of factors limiting the use of the strategy
Measured using a questionnaire
Measured: Measured at first use of the strategy and at the end of the study follow-up
Healthcare providers' perception of factors limiting the use of the strategy
Measured using a questionnaire
Measured: One and four months after the start of the study
Workload for strategy administrators
Total time taken by strategy administrators to set up the strategy, explain its functioning to participants and clean it.
Measured: Through study completion, an average of 8 months.
Strategy administrators ability to use the strategy
Measured using a questionnaire
Measured: Through study completion, an average of 8 months.
Patients' satisfaction regarding the use of the strategy
Measured using a questionnaire
Measured: Measured at first use of the strategy and at the end of the study follow-up
Healthcare providers' satisfaction regarding the strategy
Measured using a questionnaire
Measured: One and four months after the start of the study
Prevalence of adverse events related to the use of the strategy
Percentage of times when use of the strategy is stopped early due to adverse events occurring during its use.
Measured: Through study completion, an average of 8 months.
Type of adverse events related to the use of the strategy
Measured using the Simulator Sickness Questionnaire
Measured: Through study completion, an average of 8 months.
Severity of adverse events related to the use of the strategy
Measured using the Simulator Sickness Questionnaire
Measured: Through study completion, an average of 8 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start20 Nov 2024
- Primary completion29 Sep 2025
- Study completion29 Sep 2025
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.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Agency for Research on Cancer
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Leon Berard
- Responsible party
- Principal investigator, Pauline Boucheron, International Agency for Research on Cancer
- Investigators
- Pauline Boucheron, MD, Principal investigator, International Agency for Research on Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305117
- Sponsor's protocol ID
- PP202304-37-1
- Other IDs
- 101227
- Acronym
- VRtuose1
- Status last verified
- Mar 2026
- First submitted
- 22 Feb 2024
- Last updated
- 27 Mar 2026
- 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VRtuose (Virtual RealiTy and mUsic in the Oncology SEtting) : A Single-centre Feasibility Study Evaluating a Strategy Combining Virtual Reality and Music to Improve Quality of Life in Breast Cancer Patients Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT06305117
- Acronym / sponsor ID
- VRtuose1 / PP202304-37-1
- Conditions
- Breast Cancer
- Keywords
- quality of life, virtual reality, music, feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- International Agency for Research on CancerUniversity, hospital or other
- Collaborators
- Centre Leon Berard
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 12 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.
The VRtuose (Virtual RealiTy and mUsic in the Oncology Setting) project aims to evaluate the feasibility of implementing in day patient chemotherapy units a distraction strategy combining virtual reality (VR) and music which fits the needs of both breast cancer patients and healthcare providers (i.e., strategy administrators), and to evaluate its impact on patients' (i) perceived anxiety and pain during chemotherapy sessions, (ii) nausea/vomiting and mood disturbances in between chemotherapy sessions, and (iii) quality of life.
The present project is a non-randomized non-controlled prospective monocentric feasibility study which will focus on evaluating the feasibility of implementing the strategy in the target population and setting.
In the case that implementation of a distraction strategy combining virtual reality and music to improve quality of life of breast cancer patients during chemotherapy is deemed feasible, the efficacy of using this strategy to improve patients' experience of chemotherapy and long-term quality of life will be evaluated in a future randomized controlled trial informed and optimized by the results of the present work.
Detailed description
VRtuose (phase 1) is a non-randomized, single-centre, prospective, feasibility study conducted in the day patient chemotherapy unit of the Centre Léon Bérard in Lyon. This study will include women diagnosed with breast cancer who are receiving or are planned to receive any chemotherapy regimen. As this is a feasibility study, there will be no control group and all participants will be offered the intervention.
The intervention will be implemented from the first chemotherapy session onwards until it has been offered at four distinct chemotherapy sessions or until the end of patients' chemotherapy course if it is ended earlier. The intervention will be offered in addition to the standard of care at the study hospital.
All women with breast cancer who are about to start or who have started chemotherapy will be considered for inclusion in the study. All participants will be offered the distraction strategy for four consecutive chemotherapy sessions spanning over their chemotherapy course (i.e., from the first session onwards) whenever the strategy is available for use.
The intervention will be characterised by a strategy combining immersive virtual reality and music delivered during chemotherapy sessions to breast cancer patients by trained oncology nurses. Different immersive environments and of music will be available to the choice of the patient. From the first chemotherapy session onwards, patients will be offered by oncology nurses to use the distraction strategy during their chemotherapy session. Patients who are willing to use the strategy will have the possibility to choose the content of the strategy and to use it for the duration of their choice. Patients will be followed up from recruitment until they have been offered four times to use the strategy (or until the end of their chemotherapy course if it ends earlier).
This study will assess the feasibility to implement such a strategy into a day-hospital chemotherapy unit at a major oncology centre, and will therefore collect information on feasibility, acceptability and tolerability outcomes of using the strategy in this context. The efficacy of the strategy to improve patients' quality of life will not be evaluated in this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Other: Distraction strategyAs this is a feasibility study, all patients included in this study will be offered the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed diagnosis of breast cancer;
- Any disease stage;
- Patient must be receiving (i.e., with at least 4 remaining cures) or about to start palliative or curative neoadjuvant or adjuvant chemotherapy for their breast cancer at Centre Léon Bérard;
- Willingness and ability to comply with the study requirements;
- Patient must be covered by a medical insurance;
Key exclusion criteria (5 listed)
- History of condition contraindicating the use of virtual reality (e.g., epilepsy, severe motion sickness);
- Brain metastases;
- Any medical or psychosocial condition that would compromise the patient's compliance to the study procedures or would likely interfere with the completion of Patient-Reported Outcomes;
- Patients under tutorship or curatorship;
- Patients already included in another clinical trial ongoing at Centre Léon Bérard.
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 |
|---|---|---|
| Distraction strategyDistraction strategy combining the use of virtual reality and music | Other | Participants |
Primary outcome
Patients' acceptance rate regarding the use of the distraction strategy.
Time frame: Through study completion, an average of 8 months.
Average of the number of times the strategy is used by each patient out of the number of chemotherapy cures it is offered to each patient.
13 secondary outcomes
Accessibility of the strategy
Time frame: Through study completion, an average of 8 months.
Duration of use of the strategy by patients
Time frame: Through study completion, an average of 8 months.
Type of video content chosen by participants
Time frame: Through study completion, an average of 8 months.
Type of music content chosen by participants
Time frame: Through study completion, an average of 8 months.
Patients' perception of factors limiting the use of the strategy
Time frame: Measured at first use of the strategy and at the end of the study follow-up
Healthcare providers' perception of factors limiting the use of the strategy
Time frame: One and four months after the start of the study
Workload for strategy administrators
Time frame: Through study completion, an average of 8 months.
Strategy administrators ability to use the strategy
Time frame: Through study completion, an average of 8 months.
Patients' satisfaction regarding the use of the strategy
Time frame: Measured at first use of the strategy and at the end of the study follow-up
Healthcare providers' satisfaction regarding the strategy
Time frame: One and four months after the start of the study
Prevalence of adverse events related to the use of the strategy
Time frame: Through study completion, an average of 8 months.
Type of adverse events related to the use of the strategy
Time frame: Through study completion, an average of 8 months.
Severity of adverse events related to the use of the strategy
Time frame: Through study completion, an average of 8 months.
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 27 Mar 2026.
- 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.
Pauline Boucheron, MD principal investigator
International Agency for Research on Cancer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distraction strategy in people with Breast Cancer, run by International Agency for Research on Cancer 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 6 inclusion and 5 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 27 Mar 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?
Patients' acceptance rate regarding the use of the distraction strategy. (time frame: Through study completion, an average of 8 months.). 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 27 Mar 2026.