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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
6 Cognitive Behavioural Therapy (CBT) sessions should be performed after motivational interviewing up to 6 months by a psychotherapist
About 3 Hypnotherapy sessions should be performed after motivational interviewing up to 6 months by a hypnotherapist
All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
Institut de Cancerologie de l'Ouest (ICO)
Saint-Herblain, France
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
Time frame: 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 with an exhaled Carbone Monoxide (CO) measurement \< 10 ppm at study visits.
Time frame: 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.
Time frame: 12 months
Evaluate the efficacy of the different interventions in reducing tobacco consumption
Number of cigarettes smoked per day from baseline
Time frame: 12 months
Evaluate the efficacy of the different interventions in terms of continued abstinence since surgery
Percentage of patients reporting no smoking since surgery
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 12 months
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