Breast Cancer, Digestive Cancer, Gynecologic Cancer, Melanoma
Conditions
Keywords
Smoking Cessation, Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT), Hypnotherapy, Nicotine Replacement Therapy (NRT), Surgery, Surgery complications, longitudinal cohort
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.
Interventions
BEHAVIORALMotivational Interviewing (MI)
1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
BEHAVIORALCognitive Behavioural Therapy (CBT)
6 Cognitive Behavioural Therapy (CBT) sessions should be performed after motivational interviewing up to 6 months by a psychotherapist
BEHAVIORALHypnotherapy
About 3 Hypnotherapy sessions should be performed after motivational interviewing up to 6 months by a hypnotherapist
DRUGNicotine Replacement Therapy (NRT)
All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
Sponsors
Institut Cancerologie de l'Ouest
National Cancer Institute, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
pilot study, monocentric, prospective, randomization according to Zelen's design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Testing the Feasibility of Smoking Cessation Interventions Evaluated in French Cancer Patients Undergoing Surgery | 12 months | Number of patients who completed all planned sessions out of the total number of patients randomised to each group |
Countries
France
Contacts
STUDY_CHAIRSandrine Hiret, MD
Institut de Cancérologie de l'Ouest (ICO)
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment France | 6 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 6 | 0 / 3 | 1 / 6 | 1 / 6 |
| other Total, other adverse events | 1 / 6 | 0 / 3 | 1 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 3 | 0 / 6 | 0 / 6 |
Outcome results
None listed