Clinical trial NCT05289505: Evaluation of Music on the Level of Anxiety Felt During External Radiotherapy Sessions
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiotherapy Side Effect
Keywords: Anxiety
Lead sponsor: Center Eugene Marquis
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
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.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre de Lutte contre le Cancer Eugène Marquis
state: Bretagne
Study officials:
affiliation: Centre de Lutte contre le Cancer Eugène Marquis
name: Coralie Hulot
role: PRINCIPAL_INVESTIGATOR
References: