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

Institut Cancerologie de l'Ouest

Status: Terminated

Conditions: Breast Cancer; Melanoma; Digestive Cancer; Gynecologic Cancer

Treatments: Behavioral: Hypnotherapy; Drug: Nicotine Replacement Therapy (NRT); Behavioral: Cognitive Behavioural Therapy (CBT); Behavioral: Motivational Interviewing (MI)

Study type: Interventional

Funder types: Other

Identifiers

NCT04899492

ICO-2020-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 4 patient groups

Group 1:Nicotine Replacement Therapy (NRT)

Active Comparator group

Description:

Patients enrolled in group 1 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study

Treatment:

Drug: Nicotine Replacement Therapy (NRT)

Group 2:Motivational Interviewing (MI)

Experimental group

Description:

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

Treatment:

Behavioral: Motivational Interviewing (MI)

Drug: Nicotine Replacement Therapy (NRT)

Group 3:Cognitive Behavioural Therapy (CBT)

Experimental group

Description:

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

Treatment:

Behavioral: Motivational Interviewing (MI)

Behavioral: Cognitive Behavioural Therapy (CBT)

Drug: Nicotine Replacement Therapy (NRT)

Group 4: Hypnotherapy

Experimental group

Description:

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

Treatment:

Behavioral: Motivational Interviewing (MI)

Drug: Nicotine Replacement Therapy (NRT)

Behavioral: Hypnotherapy