Breast CancerRESPIRENCT04899492
Evaluating Smoking Cessation Protocols in Cancer Patients: NRT, MI, CBT or Hypnotherapy
A study testing Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) and Hypnotherapy in people with Breast Cancer and Gynecologic Cancer, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial summary
This trial offers support and assistance to patients wishing to quit smoking in order to increase the success rate of smoking cessation and all the benefits associated with it. Patients will be monitored by a tobacco specialist and will be able to benefit from one or more therapies complementary to Nicotine… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Gynecologic Cancer, Digestive Cancer
- What is being tested?
- Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) and Hypnotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2021to 29 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age ≥ 18 years.
- Smoking patient: daily tobacco consumption.
- Patient with cancer requiring surgical treatment (breast cancer, digestive cancer, gynecological).
- Patient wishing to quit smoking.
- Fagerström > 3.
- Patient has valid health insurance
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- Information and agreement of the patient to participate in the longitudinal cohort.
- Signing of specific informed consent for patients in groups 1 to 4 before any study-related intervention.
- Person able to speak, read and understand French.
Who cannot join
- Patient not receiving surgical treatment.
- Refusal to participate in the longitudinal cohort study.
- Pregnant or likely to be pregnant or nursing patient.
- Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian
- disability to undergo the medical follow-up of the trial for geographical, social or psychological reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study in Cancer Patients Scheduled for Surgery Evaluating Different Smoking Cessation Protocols : Nicotine Replacement (NRT), Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy
This trial offers support and assistance to patients wishing to quit smoking in order to increase the success rate of smoking cessation and all the benefits associated with it. Patients will be monitored by a tobacco specialist and will be able to benefit from one or more therapies complementary to Nicotine Replacement Therapy (NRT): Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy.
Read the detailed description
The study RESPIRE is aiming to identify some interventions to be proposed as part of a smoking cessation programme for smokers with cancer requiring surgical treatment and wishing to stop smoking. We aim to compare different smoking cessation methods in addition to the currently recommended treatments: Nicotine Replacement Therapy (NRT). These procedures are: Cognitive Behavioural Therapy (CBT), Motivational Interviewing (MI) or hypnotherapy in order to improve the success rate of smoking cessation in this specific population.
All patients wishing to be supported to stop smoking will be randomized and will be followed by a tobacco specialist before and after surgery. They will receive NRT for 12 months.
Smoking assessment, exhaled CO measurement, questionnaires will be completed regularly to assess depression, anxiety and quality of life during the 12 months.
Patients randomized in group 2 will receive 1 to 3 MI. Patients randomized in group 3 will receive 1 to 3 MI and 6 CBT sessions by a psychotherapist.
Patients randomized in group 4 will receive 1 to 3 MI and at least 3 sessions oh hypnotherapy.
- Conditions
- Breast Cancer, Gynecologic Cancer, Digestive Cancer, Melanoma
- Being tested
- Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT), Hypnotherapy, Nicotine Replacement Therapy (NRT)
- Keywords
- Smoking Cessation, Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT), Hypnotherapy, Nicotine Replacement Therapy (NRT), Surgery, Surgery complications, longitudinal cohort
- Medical subject headings
- Breast Neoplasms, Gastrointestinal Neoplasms, Melanoma, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing (MI)Behavioural
1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
Cognitive Behavioural Therapy (CBT)Behavioural
6 Cognitive Behavioural Therapy (CBT) sessions should be performed after motivational interviewing up to 6 months by a psychotherapist
HypnotherapyBehavioural
About 3 Hypnotherapy sessions should be performed after motivational interviewing up to 6 months by a hypnotherapist
Nicotine Replacement Therapy (NRT)Drug
All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
| Study group | Role | What they receive |
|---|---|---|
| Group 1:Nicotine Replacement Therapy (NRT) | Active comparator | Patients enrolled in group 1 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study Receives: Drug: Nicotine Replacement Therapy (NRT) |
| Group 2:Motivational Interviewing (MI) | Experimental | Patients enrolled in group 2 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization Receives: Behavioral: Motivational Interviewing (MI); Drug: Nicotine Replacement Therapy (NRT) |
| Group 3:Cognitive Behavioural Therapy (CBT) | Experimental | Patients enrolled in group 3 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization and 6 sessions of CBT after Motivational Interviewing up to 6 months after Receives: Behavioral: Motivational Interviewing (MI); Behavioral: Cognitive Behavioural Therapy (CBT); Drug: Nicotine Replacement Therapy (NRT) |
| Group 4: Hypnotherapy | Experimental | Patients enrolled in group 4 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization and about 3 sessions of hypnotherapy up to 6 months after Receives: Behavioral: Motivational Interviewing (MI); Behavioral: Hypnotherapy; Drug: Nicotine Replacement Therapy (NRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testing the Feasibility of Smoking Cessation Interventions Evaluated in French Cancer Patients Undergoing Surgery
Number of patients who completed all planned sessions out of the total number of patients randomised to each group
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start29 Sep 2021
- Primary completion29 Mar 2024
- Study completion29 Mar 2024
Why it stopped: lack of patient enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pilot study, monocentric, prospective, randomization according to Zelen's design
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Sandrine Hiret, MD, Study chair, Institut de Cancérologie de l'Ouest (ICO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899492
- Sponsor's protocol ID
- ICO-2020-14
- Acronym
- RESPIRE
- Status last verified
- Nov 2024
- First submitted
- 19 May 2021
- Last updated
- 7 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study in Cancer Patients Scheduled for Surgery Evaluating Different Smoking Cessation Protocols : Nicotine Replacement (NRT), Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy
- ClinicalTrials.gov ID
- NCT04899492
- Acronym / sponsor ID
- RESPIRE / ICO-2020-14
- Conditions
- Breast Cancer, Gynecologic Cancer, Digestive Cancer, Melanoma
- Keywords
- Smoking Cessation, Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT), Hypnotherapy, Nicotine Replacement Therapy (NRT), Surgery, Surgery complications, longitudinal cohort
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of patient enrolment
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Posted 7 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial offers support and assistance to patients wishing to quit smoking in order to increase the success rate of smoking cessation and all the benefits associated with it. Patients will be monitored by a tobacco specialist and will be able to benefit from one or more therapies complementary to Nicotine Replacement Therapy (NRT): Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy.
Detailed description
The study RESPIRE is aiming to identify some interventions to be proposed as part of a smoking cessation programme for smokers with cancer requiring surgical treatment and wishing to stop smoking. We aim to compare different smoking cessation methods in addition to the currently recommended treatments: Nicotine Replacement Therapy (NRT). These procedures are: Cognitive Behavioural Therapy (CBT), Motivational Interviewing (MI) or hypnotherapy in order to improve the success rate of smoking cessation in this specific population.
All patients wishing to be supported to stop smoking will be randomized and will be followed by a tobacco specialist before and after surgery. They will receive NRT for 12 months.
Smoking assessment, exhaled CO measurement, questionnaires will be completed regularly to assess depression, anxiety and quality of life during the 12 months.
Patients randomized in group 2 will receive 1 to 3 MI. Patients randomized in group 3 will receive 1 to 3 MI and 6 CBT sessions by a psychotherapist.
Patients randomized in group 4 will receive 1 to 3 MI and at least 3 sessions oh hypnotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- pilot study, monocentric, prospective, randomization according to Zelen's design
| Arm | Type | Receives |
|---|---|---|
| Group 1:Nicotine Replacement Therapy (NRT) | Active comparator | Drug: Nicotine Replacement Therapy (NRT)Patients enrolled in group 1 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study |
| Group 2:Motivational Interviewing (MI) | Experimental | Behavioral: Motivational Interviewing (MI), Drug: Nicotine Replacement Therapy (NRT)Patients enrolled in group 2 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization |
| Group 3:Cognitive Behavioural Therapy (CBT) | Experimental | Behavioral: Motivational Interviewing (MI), Behavioral: Cognitive Behavioural Therapy (CBT), Drug: Nicotine Replacement Therapy (NRT)Patients enrolled in group 3 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization and 6 sessions of CBT after Motivational Interviewing up to 6 months after |
| Group 4: Hypnotherapy | Experimental | Behavioral: Motivational Interviewing (MI), Behavioral: Hypnotherapy, Drug: Nicotine Replacement Therapy (NRT)Patients enrolled in group 4 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization and about 3 sessions of hypnotherapy up to 6 months after |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years.
- Smoking patient: daily tobacco consumption.
- Patient with cancer requiring surgical treatment (breast cancer, digestive cancer, gynecological).
- Patient wishing to quit smoking.
- Fagerström > 3.
Key exclusion criteria (5 listed)
- Patient not receiving surgical treatment.
- Refusal to participate in the longitudinal cohort study.
- Pregnant or likely to be pregnant or nursing patient.
- Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian
- disability to undergo the medical follow-up of the trial for geographical, social or psychological reasons.
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 |
|---|---|---|
| Motivational Interviewing (MI)1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist | Behavioural | Group 2:Motivational Interviewing (MI), Group 3:Cognitive Behavioural Therapy (CBT), Group 4: Hypnotherapy |
| Cognitive Behavioural Therapy (CBT)6 Cognitive Behavioural Therapy (CBT) sessions should be performed after motivational interviewing up to 6 months by a psychotherapist | Behavioural | Group 3:Cognitive Behavioural Therapy (CBT) |
| HypnotherapyAbout 3 Hypnotherapy sessions should be performed after motivational interviewing up to 6 months by a hypnotherapist | Behavioural | Group 4: Hypnotherapy |
| Nicotine Replacement Therapy (NRT)All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months | Drug | Group 1:Nicotine Replacement Therapy (NRT), Group 2:Motivational Interviewing (MI), Group 3:Cognitive Behavioural Therapy (CBT), Group 4: Hypnotherapy |
Primary outcome
Testing the Feasibility of Smoking Cessation Interventions Evaluated in French Cancer Patients Undergoing Surgery
Time frame: 12 months
Number of patients who completed all planned sessions out of the total number of patients randomised to each group
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Sandrine Hiret, MD study chair
Institut de Cancérologie de l'Ouest (ICO)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) and Hypnotherapy in people with Breast Cancer and Gynecologic Cancer, run by Institut Cancerologie de l'Ouest 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 9 inclusion and 5 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: stopped early, as of the sponsor's last update on 7 Aug 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?
Yes. Results are posted in the registry (first posted 7 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testing the Feasibility of Smoking Cessation Interventions Evaluated in French Cancer Patients Undergoing Surgery (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2026.