AnxietyCENSORIALNCT05856656
Music Therapy as a Tool for Anxiety Reduction in Localized Breast Cancer
A study testing Music therapy in people with Anxiety and Breast Cancer, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial summary
Breast cancer is the number one cancer in women worldwide, with 58,500 new cases in metropolitan France in 2018. The announcement of the cancer, the treatment methods and their side effects can generate unpleasant emotions, such as fear, for example, and the resources for coping with them differ according to the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety, Breast Cancer, Chemotherapy
- What is being tested?
- Music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2023to 27 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient with localized breast cancer
- Indication for adjuvant or neoadjuvant chemotherapy
- Patient > 18 years of age
- Patient with signed consent
- Patient affiliated to a social security scheme
Who cannot join
- Metastatic patient
- Triple negative patient
- Patient not eligible for curative surgery
- Patient who has already received chemotherapy
- Unaided deaf patient
- Women who are pregnant, likely to be pregnant or breastfeeding
Show all 10Show fewer
- A patient presenting a depressive episode or a psychotic pathology at the time of the initial consultation
- Patient who does not understand French
- Cognitive disorder or inability to understand,
- Patient protected by law, under court protection, guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Breast cancer is the number one cancer in women worldwide, with 58,500 new cases in metropolitan France in 2018. The announcement of the cancer, the treatment methods and their side effects can generate unpleasant emotions, such as fear, for example, and the resources for coping with them differ according to the patient. Coming to the hospital as an outpatient for chemotherapy is in itself a source of anxiety.
The use of music in the treatment process is a therapy that can help patients to reduce the intensity of their unpleasant emotions. Active music therapy involves the patient playing an instrument, including voice and body movement in rhythm, without requiring any musical skills. The presence of a qualified music therapy professional is essential, particularly in the reception of the emotions that may be generated during the sessions. These sessions can be collective or individual. In breast cancer, music therapy has been shown to be effective in reducing pain, anxiety, depressive symptoms and length of hospitalisation in patients undergoing mastectomy.
- Conditions
- Anxiety, Breast Cancer, Chemotherapy
- Being tested
- Music therapy
- Medical subject headings
- Anxiety Disorders, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyBehavioural
Music therapy is a technique of care, accompaniment and support, which aims to improve health and well-being.
| Study group | Role | What they receive |
|---|---|---|
| Music therapy arm | Experimental | A music therapy will be offered to patients before the first 3 chemotherapy cycles Receives: Behavioral: Music therapy |
| Standard care arm | No intervention | Standard patient care, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Score of State Trait Anxiety Inventory Before and After Chemotherapy
The State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-State, Form Y-A) will be used to assess patients' anxiety levels.
The score ranges from 20 to 80, with higher scores indicating greater anxiety. For each chemotherapy cycle, the STAI-State score will be collected immediately before and immediately after chemotherapy administration.
The outcome measure corresponds to the change in STAI-State score (post-chemotherapy minus pre-chemotherapy) for each cycle. The primary analysis compares the mean change in STAI-State scores between the music therapy group and the control group, calculated as the average of the pre-post differences across the first three chemotherapy cycles.
Measured: From baseline to the end of Cycle 3 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start10 Oct 2023
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnxietyStudies 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra PIQUIN, Study director, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856656
- Sponsor's protocol ID
- ICO-2022-21
- Acronym
- CENSORIAL
- Status last verified
- Jul 2025
- First submitted
- 4 May 2023
- Last updated
- 8 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy as a Tool for Anxiety Reduction in Localized Breast Cancer
- ClinicalTrials.gov ID
- NCT05856656
- Acronym / sponsor ID
- CENSORIAL / ICO-2022-21
- Conditions
- Anxiety, Breast Cancer, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 12 May 2023 (actual)
- Results
- Posted 8 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer is the number one cancer in women worldwide, with 58,500 new cases in metropolitan France in 2018. The announcement of the cancer, the treatment methods and their side effects can generate unpleasant emotions, such as fear, for example, and the resources for coping with them differ according to the patient. Coming to the hospital as an outpatient for chemotherapy is in itself a source of anxiety.
The use of music in the treatment process is a therapy that can help patients to reduce the intensity of their unpleasant emotions. Active music therapy involves the patient playing an instrument, including voice and body movement in rhythm, without requiring any musical skills. The presence of a qualified music therapy professional is essential, particularly in the reception of the emotions that may be generated during the sessions. These sessions can be collective or individual. In breast cancer, music therapy has been shown to be effective in reducing pain, anxiety, depressive symptoms and length of hospitalisation in patients undergoing mastectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music therapy arm | Experimental | Behavioral: Music therapyA music therapy will be offered to patients before the first 3 chemotherapy cycles |
| Standard care arm | No intervention | –Standard patient care, no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with localized breast cancer
- Indication for adjuvant or neoadjuvant chemotherapy
- Patient > 18 years of age
- Patient with signed consent
- Patient affiliated to a social security scheme
Key exclusion criteria (10 listed)
- Metastatic patient
- Triple negative patient
- Patient not eligible for curative surgery
- Patient who has already received chemotherapy
- Unaided deaf patient
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 |
|---|---|---|
| Music therapyMusic therapy is a technique of care, accompaniment and support, which aims to improve health and well-being. | Behavioural | Music therapy arm |
Primary outcome
Change in Score of State Trait Anxiety Inventory Before and After Chemotherapy
Time frame: From baseline to the end of Cycle 3 (each cycle is 21 days)
The State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-State, Form Y-A) will be used to assess patients' anxiety levels. The score ranges from 20 to 80, with higher scores indicating greater anxiety. For each chemotherapy cycle, the STAI-State score will be collected immediately before and immediately after chemotherapy administration. The outcome measure corresponds to the change in STAI-State score (post-chemotherapy minus pre-chemotherapy) for each cycle. The primary analysis compares the mean change in STAI-State scores between the music therapy group and the control group, calculated as the average of the pre-post differences across the first three chemotherapy cycles.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Sandra PIQUIN study director
Institut de Cancérologie de l'Ouest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy in people with Anxiety and Breast Cancer, run by Institut Cancerologie de l'Ouest 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 5 inclusion and 10 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 8 Jun 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?
Yes. Results are posted in the registry (first posted 8 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Score of State Trait Anxiety Inventory Before and After Chemotherapy (time frame: From baseline to the end of Cycle 3 (each cycle is 21 days)). 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 8 Jun 2026.