NCT07198971

Brief Summary

The innovative nature of this project lies in the combination of three types of intervention: tobacco addiction treatment, music therapy and therapeutic education. Three disciplines that work together.

  • working with the music therapist to create a personalised 'soundtrack';
  • identifying situations in which music can help them manage withdrawal symptoms;
  • using music independently in their everyday lives. The music therapy protocol will be proposed in this study, the soundtrack is co-created by the music therapist and the patient based on the patient's musical tastes and needs. The fact that the patient can use the musical tool independently also gives them significant leverage in their withdrawal process, allowing them to act on withdrawal symptoms and the main factors contributing to relapse.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

September 9, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

February 18, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

September 9, 2025

Last Update Submit

April 3, 2026

Conditions

Keywords

Smoking cessationmusic therapytobacco addiction treatment

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients who adhered to the supervised sessions, combining follow-up by a tobacco addiction nurse and follow-up in music therapy

    The patient is considered compliant if they have participated in 4 or more of the 6 supervised sessions combining tobacco addiction consultations

    From baseline to month 6

Secondary Outcomes (8)

  • Tobacco use

    at baseline, at month 3, at month 6

  • Withdrawal symptoms

    at baseline, at month 3, at month 6

  • The craving

    at baseline, at month 3, at month 6

  • Motivation

    at baseline, at month3, at month 6

  • Confidence

    at baseline, at month 3, at month 6

  • +3 more secondary outcomes

Study Arms (1)

EXPERIMENTAL

EXPERIMENTAL

Tabacco nurse consultation with music therapy session will be done at day 1 day 7 day 15 day 30 month 2 month 3 and month 6 (end of study)

Other: Music therapy

Interventions

Music therapy sessions in addition to nursing consultations: creation of a soundtrack to listen to in order to help quit smoking

EXPERIMENTAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over the age of 18
  • Patients with tobacco-related or non-tobacco-related cancer (excluding blood cancer)
  • Patients who smoke daily
  • Patients wishing to begin a smoking cessation programme
  • Patients with a prognosis of \> 1 year
  • Patients who have given their informed, written and express consent
  • Patients affiliated with a French social security scheme

You may not qualify if:

  • Patients with uncorrected hearing loss
  • Patients with unstable psychiatric conditions
  • Patients for whom regular follow-up is impossible for psychological, family, social or geographical reasons
  • Patients under guardianship, curatorship or judicial protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Du Cancer de Montpellier

Montpellier, Herault, 34298, France

RECRUITING

Related Publications (5)

  • Benowitz NL. Neurobiology of nicotine addiction: implications for smoking cessation treatment. Am J Med. 2008 Apr;121(4 Suppl 1):S3-10. doi: 10.1016/j.amjmed.2008.01.015.

    PMID: 18342164BACKGROUND
  • Jassem J. Tobacco smoking after diagnosis of cancer: clinical aspects. Transl Lung Cancer Res. 2019 May;8(Suppl 1):S50-S58. doi: 10.21037/tlcr.2019.04.01.

    PMID: 31211105BACKGROUND
  • Kathuria H, Neptune E. Primary and Secondary Prevention of Lung Cancer: Tobacco Treatment. Clin Chest Med. 2020 Mar;41(1):39-51. doi: 10.1016/j.ccm.2019.10.002.

    PMID: 32008628BACKGROUND
  • Tabac. (https://www.who.int/fr/news-room/fact-sheets/detail/tobacco). Accessed 7 December 2023.

    BACKGROUND
  • Tabac - RĂ©duire les risques de cancer. (https://www.e-cancer.fr/Comprendre-prevenir-depister/Reduire-les-risques-de-cancer/Tabac). Accessed 15 December 2023.

    BACKGROUND

MeSH Terms

Conditions

NeoplasmsSmoking Cessation

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • GONZALEZ Marie Laure, Tobacco Nurse

    marie-laure.gonzalez@icm.unicancer.fr

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aude Menteaux Music therapist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Music therapy is offered to provide additional support in the process of quitting smoking.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2025

First Posted

September 30, 2025

Study Start

February 18, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Locations