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Clinical trial

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

ID
Name
ICO-2020-14
Description
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.
Trial arms
Trial start
2021-09-29
Estimated PCD
2024-09-01
Trial end
2024-09-01
Status
Active (not recruiting)
Treatment
Motivational Interviewing (MI)
1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist
Arms:
Group 2:Motivational Interviewing (MI), Group 3:Cognitive Behavioural Therapy (CBT), Group 4: Hypnotherapy
Cognitive Behavioural Therapy (CBT)
6 Cognitive Behavioural Therapy (CBT) sessions should be performed after motivational interviewing up to 6 months by a psychotherapist
Arms:
Group 3:Cognitive Behavioural Therapy (CBT)
Hypnotherapy
About 3 Hypnotherapy sessions should be performed after motivational interviewing up to 6 months by a hypnotherapist
Arms:
Group 4: Hypnotherapy
Nicotine Replacement Therapy (NRT)
All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months
Arms:
Group 1:Nicotine Replacement Therapy (NRT), Group 2:Motivational Interviewing (MI), Group 3:Cognitive Behavioural Therapy (CBT), Group 4: Hypnotherapy
Size
100
Primary endpoint
Testing the feasibility of smoking cessation interventions evaluated in French cancer patients undergoing surgery
12 months
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "pilot study, monocentric, prospective, randomization according to Zelen's design", 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-03-12

1 organization

1 product

4 indications

Organization
Institut Cancerologie de l'Ouest
Product
Nicotine Replacement Therapy
Indication
Breast Cancer
Indication
Gynecologic Cancer
Indication
Cancer of the Digestive System
Indication
Melanoma