Evaluation of Different Smoking Cessation Protocols: Nicotine Replacement, Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy in Cancer Patients Scheduled for Surgery
NCT ID: NCT04899492
Last Updated: 2024-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
22 participants
INTERVENTIONAL
2021-09-29
2024-03-29
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1:Nicotine Replacement Therapy (NRT)
Patients enrolled in group 1 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study
Nicotine Replacement Therapy (NRT)
All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
Group 2:Motivational Interviewing (MI)
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
Motivational Interviewing (MI)
1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
Nicotine Replacement Therapy (NRT)
All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
Group 3:Cognitive Behavioural Therapy (CBT)
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
Motivational Interviewing (MI)
1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
Cognitive Behavioural Therapy (CBT)
6 Cognitive Behavioural Therapy (CBT) sessions should be performed after motivational interviewing up to 6 months by a psychotherapist
Nicotine Replacement Therapy (NRT)
All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
Group 4: Hypnotherapy
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
Motivational Interviewing (MI)
1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
Hypnotherapy
About 3 Hypnotherapy sessions should be performed after motivational interviewing up to 6 months by a hypnotherapist
Nicotine Replacement Therapy (NRT)
All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
Interventions
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Motivational Interviewing (MI)
1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
Cognitive Behavioural Therapy (CBT)
6 Cognitive Behavioural Therapy (CBT) sessions should be performed after motivational interviewing up to 6 months by a psychotherapist
Hypnotherapy
About 3 Hypnotherapy sessions should be performed after motivational interviewing up to 6 months by a hypnotherapist
Nicotine Replacement Therapy (NRT)
All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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National Cancer Institute, France
OTHER_GOV
Institut Cancerologie de l'Ouest
OTHER
Responsible Party
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Locations
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Institut de Cancerologie de l'Ouest (ICO)
Saint-Herblain, , France
Countries
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Other Identifiers
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ICO-2020-14
Identifier Type: -
Identifier Source: org_study_id
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