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Cancer (With or Without Metastasis)TEMPOSNCT07198971

Feasibility Study Incorporating Music Therapy to Optimise the Smoking Cessation Process Coordinated by a Tobacco Addiction Nurse in Smoking Patients Being Treated for Cancer

A study testing Music therapy in people with Cancer (With or Without Metastasis), run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. 1. Tobacco addiction treatment: reducing consumption, quitting, 2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer (With or Without Metastasis)
What is being tested?
Music therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteFrance
Study dates
18 Feb 2026to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Aude Menteaux Music therapist contact

04 67 61 47 63

aude.menteaux@icm.unicancer.fr

France1 site, 1 recruiting

  • Institut Du Cancer de Montpellier

    Montpellier, Herault, 34298

    Marie Laure GONZALEZ Tobacco Nurse, 04 67 61 47 08, marie-laure.gonzalez@icm.unicancer.fr

    GONZALEZ MARIE LAURE, TOBACCO NURSE

    Recruiting

Other trials in France

About this study

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.

Read more
  1. Tobacco addiction treatment: reducing consumption, quitting,
  2. Music therapy: acting on emotions and reward circuits,
  3. Therapeutic education: promoting independent healthy practices. Patients learn to use the soundtrack independently to help them manage withdrawal symptoms caused by reducing or stopping tobacco consumption.

In this programme, patients play an active role on several levels:

  • 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.
Read the detailed description

Music therapy could address the three elements mentioned above:

  • add a practitioner other than the tobacco specialist,
  • increase the patient's perception of self-efficacy,
  • provide the patient with a personalised soundtrack that may have an effect on withdrawal symptoms associated with smoking cessation.

Music therapy could increase the chances of successful cessation. It therefore seems innovative to offer an educational intervention combining the tobacco specialist nurse and the music therapist, which would enable patients to use a musical tool co-developed with the music therapist independently at home. There are no data on the learning and use of such a tool to reinforce self-efficacy in managing smoking cessation. The analysis of the existing literature is poor in terms of music therapy and addiction and virtually non-existent in terms of tobacco addiction.

The objective is to evaluate the feasibility of an intervention combining tobacco addiction treatment and music therapy and its impact on smoking cessation symptoms in patients with cancer who smoke.

Being tested
Music therapy
Keywords
Smoking cessation, music therapy, tobacco addiction treatment
Medical subject headings
Neoplasms, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Music therapyOther

    Music therapy sessions in addition to nursing consultations:

    creation of a soundtrack to listen to in order to help quit smoking

Study groups in NCT07198971
Study groupRoleWhat they receive
EXPERIMENTALExperimentalTabacco 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)
Receives: Other: Music therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From baseline to month 6

Secondary outcomes (8)

  1. Tobacco use

    Number of cigarettes smoked per day and Measurement of exhaled CO and Tobacco dependence scale score: Simplified Fagerström Test

    Measured: at baseline, at month 3, at month 6

  2. Withdrawal symptoms

    Scores on the Smoking Cessation Scale

    Measured: at baseline, at month 3, at month 6

  3. The craving

    Scores obtained on the French Tobacco Craving Questionnaire

    Measured: at baseline, at month 3, at month 6

  4. Motivation

    Scores on the 0-10 Digital Scale assessing motivation

    Measured: at baseline, at month3, at month 6

  5. Confidence

    Scores on the EN assessing confidence

    Measured: at baseline, at month 3, at month 6

  6. Sense of personal competence

    General Self Efficacy Scale questionnaire

    Measured: at baseline, at month 3, at month 6

  7. Symptoms of anxiety and depression

    Anxiety and depression scores on the Hospital Anxiety and Depression Scale

    Measured: at baseline, at month 3, at month 6

  8. Describe adherence to independent listening in music therapy between T2 and T6.

    Describe the number of times the patient listened to the audio recording per day, as recorded in a logbook.

    Measured: at baseline, at month 3 and at month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2025
  2. Study start18 Feb 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Music therapy is offered to provide additional support in the process of quitting smoking.
Masking
None (open label)
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07198971
Sponsor's protocol ID
PROICM 2025-02 TEM
Acronym
TEMPOS
Status last verified
Apr 2026
First submitted
9 Sep 2025
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 18342164

  • 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.

    PubMed 31211105

  • 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.

    PubMed 32008628

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

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

Questions about this trial

What is this clinical trial studying?

A study testing Music therapy in people with Cancer (With or Without Metastasis), run by Institut du Cancer de Montpellier - Val d'Aurelle 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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 9 Apr 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aude Menteaux Music therapist (04 67 61 47 63, aude.menteaux@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who adhered to the supervised sessions, combining follow-up by a tobacco addiction nurse and follow-up in music therapy (time frame: From baseline to month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07198971, which also lists 5 linked publications.

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 9 Apr 2026.

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