Clinical trial NCT04899492: Evaluation of Different Smoking Cessation Protocols: Nicotine Replacement, Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy in Cancer Patients Scheduled for Surgery
Official title: Pilot Study in Cancer Patients Scheduled for Surgery Evaluating Different Smoking Cessation Protocols : Nicotine Replacement, Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2021-05-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pilot study, monocentric, prospective, randomization according to Zelen's design
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Testing the feasibility of smoking cessation interventions evaluated in French cancer patients undergoing surgery
timeFrame: 12 months
Secondary outcomes:
measure: Evaluate the efficacy of the following interventions for smoking cessation in French cancer patients: MI, CBT and Hypnotherapy, combined with nicotine replacement therapy
timeFrame: 12 months
measure: Evaluate the efficacy of the following interventions for smoking cessation in French cancer patients: MI, CBT and Hypnotherapy, combined with nicotine replacement therapy
timeFrame: 12 months
measure: Evaluate the efficacy of the different interventions in reducing tobacco consumption
timeFrame: 12 months
measure: Evaluate the efficacy of the different interventions in terms of continued abstinence since surgery
timeFrame: 12 months
measure: Evaluate the reduction in side effects of oncological treatments after smoking cessation
timeFrame: 3 month
measure: Estimate the decrease in surgical complications
timeFrame: 1 month
measure: Evaluate the efficacy of interventions on patient depression and anxiety
timeFrame: 12 months
measure: Evaluate the efficacy of interventions on patient quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Saint-Herblain
country: France
facility: Institut de Cancerologie de l'Ouest (ICO)
Study officials:
References: