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Music Therapy as a Tool for Anxiety Reduction in Localized Breast Cancer (CENSORIAL)

Primary Purpose

Anxiety, Breast Cancer, Chemotherapy

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Music therapy
Sponsored by
Institut Cancerologie de l'Ouest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Sites / Locations

  • Institut de Cancérologie de l'Ouest

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Music therapy arm

Standard care arm

Arm Description

A music therapy will be offered to patients before the first 3 chemotherapy cycles

Standard patient care, no intervention

Outcomes

Primary Outcome Measures

To evaluate the impact of music therapy on anxiety in breast cancer patients undergoing adjuvant or neoadjuvant chemotherapy.
Changes in anxiety before the first and third chemotherapy sessions will be measured using the State Trait Anxiety Inventory (= STAI etat score).

Secondary Outcome Measures

Full Information

First Posted
May 4, 2023
Last Updated
June 19, 2023
Sponsor
Institut Cancerologie de l'Ouest
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1. Study Identification

Unique Protocol Identification Number
NCT05856656
Brief Title
Music Therapy as a Tool for Anxiety Reduction in Localized Breast Cancer
Acronym
CENSORIAL
Official Title
Music Therapy as a Tool for Anxiety Reduction in Localized Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Breast Cancer, Chemotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music therapy arm
Arm Type
Experimental
Arm Description
A music therapy will be offered to patients before the first 3 chemotherapy cycles
Arm Title
Standard care arm
Arm Type
No Intervention
Arm Description
Standard patient care, no intervention
Intervention Type
Behavioral
Intervention Name(s)
Music therapy
Intervention Description
Music therapy is a technique of care, accompaniment and support, which aims to improve health and well-being.
Primary Outcome Measure Information:
Title
To evaluate the impact of music therapy on anxiety in breast cancer patients undergoing adjuvant or neoadjuvant chemotherapy.
Description
Changes in anxiety before the first and third chemotherapy sessions will be measured using the State Trait Anxiety Inventory (= STAI etat score).
Time Frame
5 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra PIQUIN
Phone
+ 33 2 41 35 27 00
Email
sandra.piquin@ico.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marine TIGREAT
Email
marine.tigreat@ico.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra PIQUIN
Organizational Affiliation
Institut de Cancérologie de l'Ouest
Official's Role
Study Director
Facility Information:
Facility Name
Institut de Cancérologie de l'Ouest
City
Angers
ZIP/Postal Code
49055
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra PIQUIN
Email
sandra.piquin@ico.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Marine TIGREAT
Email
marine.tigreat@ico.unicancer.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Music Therapy as a Tool for Anxiety Reduction in Localized Breast Cancer

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