Evaluation of Different Smoking Cessation Protocols: Nicotine Replacement, Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy in Cancer Patients Scheduled for Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study in Cancer Patients Scheduled for Surgery Evaluating Different Smoking Cessation Protocols : Nicotine Replacement, Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy

Conditions
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Breast Cancer, Gynecologic Cancer, Digestive Cancer, Melanoma

Intervention / Treatment
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* Behavioral: Motivational Interviewing (MI)
* Behavioral: Cognitive Behavioural Therapy (CBT)
* Behavioral: Hypnotherapy
* Drug: Nicotine Replacement Therapy (NRT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: pilot study, monocentric, prospective, randomization according to Zelen's design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1:Nicotine Replacement Therapy (NRT)<br>Patients enrolled in group 1 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study | Drug: Nicotine Replacement Therapy (NRT)<br>* All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months<br>|
| Experimental: Group 2:Motivational Interviewing (MI)<br>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 | Behavioral: Motivational Interviewing (MI)<br>* 1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist<br>Drug: Nicotine Replacement Therapy (NRT)<br>* All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months<br>|
| Experimental: Group 3:Cognitive Behavioural Therapy (CBT)<br>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 | Behavioral: Motivational Interviewing (MI)<br>* 1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist<br>Behavioral: Cognitive Behavioural Therapy (CBT)<br>* 6 Cognitive Behavioural Therapy (CBT) sessions should be performed after motivational interviewing up to 6 months by a psychotherapist<br>Drug: Nicotine Replacement Therapy (NRT)<br>* All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months<br>|
| Experimental: Group 4: Hypnotherapy<br>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 | Behavioral: Motivational Interviewing (MI)<br>* 1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist<br>Behavioral: Hypnotherapy<br>* About 3 Hypnotherapy sessions should be performed after motivational interviewing up to 6 months by a hypnotherapist<br>Drug: Nicotine Replacement Therapy (NRT)<br>* All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the efficacy of the following interventions for smoking cessation in French cancer patients: MI, CBT and Hypnotherapy, combined with nicotine replacement therapy | Percentage of patients with an exhaled Carbone Monoxide (CO) measurement < 10 ppm at study visits. | 12 months | 
| Evaluate the efficacy of the following interventions for smoking cessation in French cancer patients: MI, CBT and Hypnotherapy, combined with nicotine replacement therapy | Percentage of patients reporting no smoking during the last 7 days before the visit. | 12 months | 
| Evaluate the efficacy of the different interventions in reducing tobacco consumption | Number of cigarettes smoked per day from baseline | 12 months | 
| Evaluate the efficacy of the different interventions in terms of continued abstinence since surgery | Percentage of patients reporting no smoking since surgery | 12 months | 
| Evaluate the reduction in side effects of oncological treatments after smoking cessation | Report all Grade > 1 side effects of oncology treatments up to 3 months after the end of treatment or the end of the study | 3 month | 
| Estimate the decrease in surgical complications | Report all surgical complications (Grade > 1 according to Clavien Dindo classification) up to 1 month after surgery | 1 month | 
| Evaluate the efficacy of interventions on patient depression and anxiety | Patient Depression and anxiety will be evaluated by using the Hospital Anxiety and Depression Scale (HADS) | 12 months | 
| Evaluate the efficacy of interventions on patient quality of life | Patient quality of life will be evaluated by using the Quality of Life Questionnaire (QLQ-C30) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation, Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT), Hypnotherapy, Nicotine Replacement Therapy (NRT), Surgery, Surgery complications, longitudinal cohort