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

Breast Cancer Clinical Trial

— RESPIRE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04899492
• Other study ID #: ICO-2020-14
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 29, 2021
• Est. completion date: September 2024

Study information

• Verified date: February 2024
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Digestive Cancer
• Gynecologic Cancer
• Melanoma

Intervention

Behavioral:
• Motivational Interviewing (MI)
1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
• Cognitive Behavioural Therapy (CBT)
6 Cognitive Behavioural Therapy (CBT) sessions should be performed after motivational interviewing up to 6 months by a psychotherapist
• Hypnotherapy
About 3 Hypnotherapy sessions should be performed after motivational interviewing up to 6 months by a hypnotherapist

Drug:
• Nicotine Replacement Therapy (NRT)
All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months

Locations

Country	Name	City	State
France	Institut de Cancerologie de l'Ouest (ICO)	Saint-Herblain

Sponsors (2)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest	National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Evaluate the efficacy of the different interventions in reducing tobacco consumption	Number of cigarettes smoked per day from baseline	12 months
Secondary	Evaluate the efficacy of the different interventions in terms of continued abstinence since surgery	Percentage of patients reporting no smoking since surgery	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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