Evaluation of Different Smoking Cessation Protocols: Nicotine Replacement, Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy in Cancer Patients Scheduled for Surgery
- Conditions
- Digestive CancerMelanomaBreast CancerGynecologic Cancer
- Interventions
- Behavioral: Motivational Interviewing (MI)Behavioral: Cognitive Behavioural Therapy (CBT)Behavioral: Hypnotherapy
- Registration Number
- NCT04899492
- Lead Sponsor
- Institut Cancerologie de l'Ouest
- Brief 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 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 22
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2:Motivational Interviewing (MI) 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 Group 1:Nicotine Replacement Therapy (NRT) 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) 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 4: Hypnotherapy Motivational Interviewing (MI) 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 Group 3:Cognitive Behavioural Therapy (CBT) Motivational Interviewing (MI) 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 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 Group 3:Cognitive Behavioural Therapy (CBT) 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 Group 3:Cognitive Behavioural Therapy (CBT) 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 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
- Primary Outcome Measures
Name Time Method Testing the feasibility of smoking cessation interventions evaluated in French cancer patients undergoing surgery 12 months Number of patients who completed all planned sessions out of the total number of patients randomised to each group
- Secondary Outcome Measures
Name Time Method Evaluate the efficacy of the following interventions for smoking cessation in French cancer patients: MI, CBT and Hypnotherapy, combined with nicotine replacement therapy 12 months Percentage of patients reporting no smoking during the last 7 days before the visit.
Evaluate the efficacy of the different interventions in reducing tobacco consumption 12 months Number of cigarettes smoked per day from baseline
Evaluate the efficacy of interventions on patient depression and anxiety 12 months Patient Depression and anxiety will be evaluated by using the Hospital Anxiety and Depression Scale (HADS)
Evaluate the efficacy of interventions on patient quality of life 12 months Patient quality of life will be evaluated by using the Quality of Life Questionnaire (QLQ-C30)
Evaluate the reduction in side effects of oncological treatments after smoking cessation 3 month Report all Grade \> 1 side effects of oncology treatments up to 3 months after the end of treatment or the end of the study
Estimate the decrease in surgical complications 1 month Report all surgical complications (Grade \> 1 according to Clavien Dindo classification) up to 1 month after surgery
Evaluate the efficacy of the different interventions in terms of continued abstinence since surgery 12 months Percentage of patients reporting no smoking since surgery
Trial Locations
- Locations (1)
Institut de Cancerologie de l'Ouest (ICO)
🇫🇷Saint-Herblain, France