Radiotherapy Side EffectMUSIC-RTNCT05289505
Evaluation of Music on the Level of Anxiety Felt During External Radiotherapy Sessions
An observational study of Radiotherapy Side Effect, run by Center Eugene Marquis at 1 site in France.
Trial summary
This is a prospective study with a historical comparator. Each of the prospective study endpoints will be compared to data collected retrospectively in patients treated with radiation therapy prior to the implementation of the MUSIC-CARE device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiotherapy Side Effect
- What is being tested?
- MUSIC-CARE
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 83 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2022to 26 Mar 2023
- Phase
- Observational
- 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
Study population: All patients, all cancers combined, with an initial HADS score > 7 and initiating treatment in the radiotherapy department are concerned by this study.
Who may be able to join
- Patients over 18 years of age
- Patients undergoing radiotherapy for curative treatment
- Patients with at least 15 sessions of radiotherapy
- Patients with an anxiety score > 7 on the total A of the HADS scale at the time of medical consultation
Who cannot join
- Minor patients
- Pregnant or breastfeeding patients
- Patients with major hearing loss
- Patients with psychotic disorders
- Patients who do not understand or read the French language
- Patients under guardianship or deprived of liberty
- Patients requiring radiotherapy with respiratory servo-control (the MUSIC-CARE cannot be used due to technical constraints)
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Lutte contre le Cancer Eugène Marquis
Rennes, Brittany Region, 35042
About this study
Official title: Prospective and Monocentric Pilot Study of the Evaluation of the Music Delivered by the Music-Care Device on the Level of Anxiety Felt During External Radiotherapy Sessions
This is a prospective study with a historical comparator. Each of the prospective study endpoints will be compared to data collected retrospectively in patients treated with radiation therapy prior to the implementation of the MUSIC-CARE device.
Read the detailed description
The retrospective phase (historical comparator) includes all patients with an initial HADS score > 7 who were treated with radiotherapy during 6 months preceding the start of the prospective study. The prospective phase involves all patients with an initial HADS score > 7 who will be treated with radiotherapy and who will benefit from music sessions (MUSIC-CARE). The study will be conducted over a fixed period of 12 months (6 months recruitment and 6 months follow-up) from the first patient receiving music sessions. Anxiety will be assessed by HADS self-questionnaires, before radiotherapy, at the end of the first week and at the end of radiotherapy. These evaluation parameters will therefore be compared to the 6-month period prior to the start of the study (retrospective phase).
- Conditions
- Radiotherapy Side Effect
- Being tested
- MUSIC-CARE
- Keywords
- Anxiety
- Medical subject headings
- Radiation Injuries, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MUSIC-CAREDevice
This device allows the listening of music using different sequences of instrumental music created specifically, and using principles based on hypno-analgesia, that is to say the association of hypnotic techniques and approaches to help or analgesic, medicated or not. It consists of a tablet application containing instrumental music pieces, specially created and recorded for Music-Care. Each piece is at least 20 minutes long. The music can be played through headphones or speakers.
| Study group | Role | What they receive |
|---|---|---|
| Prospective phase | This prospective phase involves all patients with an initial HADS score > 7 and initiating treatment in the radiotherapy department. The treatment sessions will be performed with music, using the MUSIC-CARE device. In the event of technical problems, unavailability of equipment, or the patient's wishes, some radiotherapy sessions may be conducted without music. Nevertheless, a minimum of one weekly session with music is required for the analysis of the study. Receives: Device: MUSIC-CARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective of the study is to evaluate the impact of the MUSIC-CARE device on the level of anxiety perceived by patients during radiotherapy.
Perceived anxiety will be measured by the anxiety score (total A), assessed with the Hospital Anxiety and Depression Scale (HADS). To screen for anxiety symptomatology, the following interpretation is: Total A score at 7 or less: no symptomatology, Total A score of 8 to 10: questionable symptomatology, and Total A score equal to 11 and above: definite symptomatology. Anxiety will be assessed at the medical consultation, after 5 sessions and at the end of the treatment. The patients' score after 5 sessions will be used as the primary endpoint to evaluate the impact of the to evaluate the impact of the device.
Measured: The analysis will take place after the last visit (usual 6-month visit) of the last included patient, i.e. 6 months after the end of treatment of the last patient, and within a maximum of one year after this visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start18 Jan 2022
- Primary completion31 Aug 2022
- Study completion26 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiotherapy Side EffectStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center Eugene Marquis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Coralie Hulot, Principal investigator, Centre de Lutte contre le Cancer Eugène Marquis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289505
- Sponsor's protocol ID
- 2019-6-63-004
- Other IDs
- 2021-A00597-37
- Acronym
- MUSIC-RT
- Status last verified
- Sep 2022
- First submitted
- 25 Jan 2022
- Last updated
- 4 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 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Monocentric Pilot Study of the Evaluation of the Music Delivered by the Music-Care Device on the Level of Anxiety Felt During External Radiotherapy Sessions
- ClinicalTrials.gov ID
- NCT05289505
- Acronym / sponsor ID
- MUSIC-RT / 2019-6-63-004
- Conditions
- Radiotherapy Side Effect
- Keywords
- Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Center Eugene MarquisUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 26 Mar 2023 (actual)
- First posted
- 21 Mar 2022 (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 is a prospective study with a historical comparator. Each of the prospective study endpoints will be compared to data collected retrospectively in patients treated with radiation therapy prior to the implementation of the MUSIC-CARE device.
Detailed description
The retrospective phase (historical comparator) includes all patients with an initial HADS score > 7 who were treated with radiotherapy during 6 months preceding the start of the prospective study. The prospective phase involves all patients with an initial HADS score > 7 who will be treated with radiotherapy and who will benefit from music sessions (MUSIC-CARE). The study will be conducted over a fixed period of 12 months (6 months recruitment and 6 months follow-up) from the first patient receiving music sessions. Anxiety will be assessed by HADS self-questionnaires, before radiotherapy, at the end of the first week and at the end of radiotherapy. These evaluation parameters will therefore be compared to the 6-month period prior to the start of the study (retrospective phase).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective phase | – | Device: MUSIC-CAREThis prospective phase involves all patients with an initial HADS score > 7 and initiating treatment in the radiotherapy department. The treatment sessions will be performed with music, using the MUSIC-CARE device. In the event of technical problems, unavailability of equipment, or the patient's wishes, some radiotherapy sessions may be conducted without music. Nevertheless, a minimum of one weekly session with music is required for the analysis of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients, all cancers combined, with an initial HADS score > 7 and initiating treatment in the radiotherapy department are concerned by this study.
Key inclusion criteria (4 listed)
- Patients over 18 years of age
- Patients undergoing radiotherapy for curative treatment
- Patients with at least 15 sessions of radiotherapy
- Patients with an anxiety score > 7 on the total A of the HADS scale at the time of medical consultation
Key exclusion criteria (7 listed)
- Minor patients
- Pregnant or breastfeeding patients
- Patients with major hearing loss
- Patients with psychotic disorders
- Patients who do not understand or read the French language
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-CAREThis device allows the listening of music using different sequences of instrumental music created specifically, and using principles based on hypno-analgesia, that is to say the association of hypnotic techniques and approaches to help or analgesic, medicated or not. It consists of a tablet application containing instrumental music pieces, specially created and recorded for Music-Care. Each piece is at least 20 minutes long. The music can be played through headphones or speakers. | Device | Prospective phase |
Primary outcome
The main objective of the study is to evaluate the impact of the MUSIC-CARE device on the level of anxiety perceived by patients during radiotherapy.
Time frame: The analysis will take place after the last visit (usual 6-month visit) of the last included patient, i.e. 6 months after the end of treatment of the last patient, and within a maximum of one year after this visit.
Perceived anxiety will be measured by the anxiety score (total A), assessed with the Hospital Anxiety and Depression Scale (HADS). To screen for anxiety symptomatology, the following interpretation is: Total A score at 7 or less: no symptomatology, Total A score of 8 to 10: questionable symptomatology, and Total A score equal to 11 and above: definite symptomatology. Anxiety will be assessed at the medical consultation, after 5 sessions and at the end of the treatment. The patients' score after 5 sessions will be used as the primary endpoint to evaluate the impact of the to evaluate the impact of the device.
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 4 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.
Coralie Hulot principal investigator
Centre de Lutte contre le Cancer Eugène Marquis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiotherapy Side Effect, run by Center Eugene Marquis 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 4 inclusion and 7 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 4 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 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?
The main objective of the study is to evaluate the impact of the MUSIC-CARE device on the level of anxiety perceived by patients during radiotherapy. (time frame: The analysis will take place after the last visit (usual 6-month visit) of the last included patient, i.e. 6 months after the end of treatment of the last patient, and within a maximum of one year after this visit.). 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 4 Apr 2024.