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

Primary Purpose

Breast Cancer, Gynecologic Cancer, Digestive Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Motivational Interviewing (MI)
Cognitive Behavioural Therapy (CBT)
Hypnotherapy
Nicotine Replacement Therapy (NRT)
Sponsored by
Institut Cancerologie de l'Ouest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Smoking Cessation, Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT), Hypnotherapy, Nicotine Replacement Therapy (NRT), Surgery, Surgery complications, longitudinal cohort

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Institut de Cancerologie de l'Ouest (ICO)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Group 1:Nicotine Replacement Therapy (NRT)

Group 2:Motivational Interviewing (MI)

Group 3:Cognitive Behavioural Therapy (CBT)

Group 4: Hypnotherapy

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Evaluate the efficacy of the different interventions in reducing tobacco consumption
Number of cigarettes smoked per day from baseline
Evaluate the efficacy of the different interventions in terms of continued abstinence since surgery
Percentage of patients reporting no smoking since surgery
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
Estimate the decrease in surgical complications
Report all surgical complications (Grade > 1 according to Clavien Dindo classification) up to 1 month after surgery
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)
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)

Full Information

First Posted
May 19, 2021
Last Updated
August 29, 2022
Sponsor
Institut Cancerologie de l'Ouest
Collaborators
National Cancer Institute, France
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1. Study Identification

Unique Protocol Identification Number
NCT04899492
Brief Title
Evaluation of Different Smoking Cessation Protocols: Nicotine Replacement, Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy in Cancer Patients Scheduled for Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest
Collaborators
National Cancer Institute, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
pilot study, monocentric, prospective, randomization according to Zelen's design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1:Nicotine Replacement Therapy (NRT)
Arm Type
Active Comparator
Arm Description
Patients enrolled in group 1 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study
Arm Title
Group 2:Motivational Interviewing (MI)
Arm Type
Experimental
Arm 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
Arm Title
Group 3:Cognitive Behavioural Therapy (CBT)
Arm Type
Experimental
Arm 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
Arm Title
Group 4: Hypnotherapy
Arm Type
Experimental
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing (MI)
Intervention Description
1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy (CBT)
Intervention Description
6 Cognitive Behavioural Therapy (CBT) sessions should be performed after motivational interviewing up to 6 months by a psychotherapist
Intervention Type
Behavioral
Intervention Name(s)
Hypnotherapy
Intervention Description
About 3 Hypnotherapy sessions should be performed after motivational interviewing up to 6 months by a hypnotherapist
Intervention Type
Drug
Intervention Name(s)
Nicotine Replacement Therapy (NRT)
Intervention Description
All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
Primary Outcome Measure Information:
Title
Testing the feasibility of smoking cessation interventions evaluated in French cancer patients undergoing surgery
Description
Number of patients who completed all planned sessions out of the total number of patients randomised to each group
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Evaluate the efficacy of the following interventions for smoking cessation in French cancer patients: MI, CBT and Hypnotherapy, combined with nicotine replacement therapy
Description
Percentage of patients with an exhaled Carbone Monoxide (CO) measurement < 10 ppm at study visits.
Time Frame
12 months
Title
Evaluate the efficacy of the following interventions for smoking cessation in French cancer patients: MI, CBT and Hypnotherapy, combined with nicotine replacement therapy
Description
Percentage of patients reporting no smoking during the last 7 days before the visit.
Time Frame
12 months
Title
Evaluate the efficacy of the different interventions in reducing tobacco consumption
Description
Number of cigarettes smoked per day from baseline
Time Frame
12 months
Title
Evaluate the efficacy of the different interventions in terms of continued abstinence since surgery
Description
Percentage of patients reporting no smoking since surgery
Time Frame
12 months
Title
Evaluate the reduction in side effects of oncological treatments after smoking cessation
Description
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
Title
Estimate the decrease in surgical complications
Description
Report all surgical complications (Grade > 1 according to Clavien Dindo classification) up to 1 month after surgery
Time Frame
1 month
Title
Evaluate the efficacy of interventions on patient depression and anxiety
Description
Patient Depression and anxiety will be evaluated by using the Hospital Anxiety and Depression Scale (HADS)
Time Frame
12 months
Title
Evaluate the efficacy of interventions on patient quality of life
Description
Patient quality of life will be evaluated by using the Quality of Life Questionnaire (QLQ-C30)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte BOURGIN, MD
Phone
+33 2 40 67 99 00
Email
charolotte.bourgin@ico.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nadia ALLAM, PhD
Phone
+ 33 2 40 67 98 26
Email
nadia.allam@ico.unicancer.fr
Facility Information:
Facility Name
Institut de Cancerologie de l'Ouest (ICO)
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte BOURGIN, MD
Phone
+33 2 40 67 99 00
Email
charlotte.bourgin@ico.unicancer.fr

12. IPD Sharing Statement

Learn more about this trial

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

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