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.
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.
France1 site, 1 recruiting
- 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
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
- Tobacco addiction treatment: reducing consumption, quitting,
- Music therapy: acting on emotions and reward circuits,
- 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.
- Conditions
- Cancer (With or Without Metastasis)
- 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 group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
Withdrawal symptoms
Scores on the Smoking Cessation Scale
Measured: at baseline, at month 3, at month 6
The craving
Scores obtained on the French Tobacco Craving Questionnaire
Measured: at baseline, at month 3, at month 6
Motivation
Scores on the 0-10 Digital Scale assessing motivation
Measured: at baseline, at month3, at month 6
Confidence
Scores on the EN assessing confidence
Measured: at baseline, at month 3, at month 6
Sense of personal competence
General Self Efficacy Scale questionnaire
Measured: at baseline, at month 3, at month 6
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
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.
- First posted30 Sep 2025
- Study start18 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cancer (With or Without Metastasis)Studies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- 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
- 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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GONZALEZ Marie Laure, Tobacco Nurse, Principal investigator, marie-laure.gonzalez@icm.unicancer.fr
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 18342164Jassem 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 31211105Kathuria 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 32008628Tabac. (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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study Incorporating Music Therapy to Optimise the Smoking Cessation Process Coordinated by a Tobacco Addiction Nurse in Smoking Patients Being Treated for Cancer
- ClinicalTrials.gov ID
- NCT07198971
- Acronym / sponsor ID
- TEMPOS / PROICM 2025-02 TEM
- Conditions
- Cancer (With or Without Metastasis)
- Keywords
- Smoking cessation, music therapy, tobacco addiction treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Sep 2025 (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.
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.
- Tobacco addiction treatment: reducing consumption, quitting,
- Music therapy: acting on emotions and reward circuits,
- 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Music therapy is offered to provide additional support in the process of quitting smoking.
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL | Experimental | Other: Music therapyTabacco 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 therapyMusic therapy sessions in addition to nursing consultations: creation of a soundtrack to listen to in order to help quit smoking | Other | EXPERIMENTAL |
Primary outcome
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
The patient is considered compliant if they have participated in 4 or more of the 6 supervised sessions combining tobacco addiction consultations
8 secondary outcomes
Tobacco use
Time frame: at baseline, at month 3, at month 6
Withdrawal symptoms
Time frame: at baseline, at month 3, at month 6
The craving
Time frame: at baseline, at month 3, at month 6
Motivation
Time frame: at baseline, at month3, at month 6
Confidence
Time frame: at baseline, at month 3, at month 6
Sense of personal competence
Time frame: at baseline, at month 3, at month 6
Symptoms of anxiety and depression
Time frame: at baseline, at month 3, at month 6
Describe adherence to independent listening in music therapy between T2 and T6.
Time frame: at baseline, at month 3 and at month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Background: PubMed 18342164Benowitz 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.
- Background: PubMed 31211105Jassem 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.
- Background: PubMed 32008628Kathuria 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.
- BackgroundTabac. (https://www.who.int/fr/news-room/fact-sheets/detail/tobacco). Accessed 7 December 2023.
- BackgroundTabac - Réduire les risques de cancer. (https://www.e-cancer.fr/Comprendre-prevenir-depister/Reduire-les-risques-de-cancer/Tabac). Accessed 15 December 2023.
- Individual participant dataSharing planned: Yes
Related trials for Cancer (With or Without Metastasis)
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
Active, not recruitingPhase 3
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
Neoplasms
RecruitingPhase 3
A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)
Metastatic Colorectal Cancer
RecruitingPhase 2/3
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
HER2-positive Breast Cancer
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.
GONZALEZ Marie Laure, Tobacco Nurse principal investigator
marie-laure.gonzalez@icm.unicancer.fr
1 site in 1 country: see every site and its status.
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.