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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Melanoma; Breast Cancer; Gynecologic Cancer; Digestive Cancer
• Intervention / Treatment: Drug: Nicotine Replacement Therapy (NRT); Behavioral: Motivational Interviewing (MI); Behavioral: Cognitive Behavioural Therapy (CBT); Behavioral: 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charlotte BOURGIN, MD; Phone Number: +33 2 40 67 99 00; Email: charolotte.bourgin@ico.unicancer.fr
• Study Contact Backup: Name: Nadia ALLAM, PhD; Phone Number: + 33 2 40 67 98 26; Email: nadia.allam@ico.unicancer.fr

Study Locations

• France
  • Saint-Herblain, France, 44805
    • Institut de cancerologie de l'ouest (ICO)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1:Nicotine Replacement Therapy (NRT); 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); All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
Experimental: Group 2: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	Drug: Nicotine Replacement Therapy (NRT); All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months; Behavioral: Motivational Interviewing (MI); 1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
Experimental: Group 3: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	Drug: Nicotine Replacement Therapy (NRT); All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months; Behavioral: Motivational Interviewing (MI); 1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist; Behavioral: Cognitive Behavioural Therapy (CBT); 6 Cognitive Behavioural Therapy (CBT) sessions should be performed after motivational interviewing up to 6 months by a psychotherapist
Experimental: Group 4: 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	Drug: Nicotine Replacement Therapy (NRT); All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months; Behavioral: Motivational Interviewing (MI); 1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist; Behavioral: Hypnotherapy; About 3 Hypnotherapy sessions should be performed after motivational interviewing up to 6 months by a hypnotherapist

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut Cancerologie de l'Ouest
• Collaborators: National Cancer Institute, France

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2021
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Surgery; Hypnotherapy; Smoking Cessation; Cognitive Behavioural Therapy (CBT); Nicotine Replacement Therapy (NRT); Motivational Interviewing (MI); Surgery complications; longitudinal cohort
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Melanoma; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: ICO-2020-14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No