Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-26 @ 9:17 PM
Study NCT ID:
NCT04899492
Status:
TERMINATED
Last Update Posted:
2024-11-07
First Post:
2021-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D006990', 'term': 'Hypnosis'}, {'id': 'D000095488', 'term': 'Nicotine Replacement Therapy'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "pilot study, monocentric, prospective, randomization according to Zelen's design"}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'whyStopped': 'lack of patient enrolment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-05', 'studyFirstSubmitDate': '2021-05-19', 'studyFirstSubmitQcDate': '2021-05-19', 'lastUpdatePostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Testing the feasibility of smoking cessation interventions evaluated in French cancer patients undergoing surgery', 'timeFrame': '12 months', 'description': 'Number of patients who completed all planned sessions out of the total number of patients randomised to each group'}], 'secondaryOutcomes': [{'measure': 'Evaluate the efficacy of the following interventions for smoking cessation in French cancer patients: MI, CBT and Hypnotherapy, combined with nicotine replacement therapy', 'timeFrame': '12 months', 'description': 'Percentage of patients with an exhaled Carbone Monoxide (CO) measurement \\< 10 ppm at study visits.'}, {'measure': 'Evaluate the efficacy of the following interventions for smoking cessation in French cancer patients: MI, CBT and Hypnotherapy, combined with nicotine replacement therapy', 'timeFrame': '12 months', 'description': 'Percentage of patients reporting no smoking during the last 7 days before the visit.'}, {'measure': 'Evaluate the efficacy of the different interventions in reducing tobacco consumption', 'timeFrame': '12 months', 'description': 'Number of cigarettes smoked per day from baseline'}, {'measure': 'Evaluate the efficacy of the different interventions in terms of continued abstinence since surgery', 'timeFrame': '12 months', 'description': 'Percentage of patients reporting no smoking since surgery'}, {'measure': 'Evaluate the reduction in side effects of oncological treatments after smoking cessation', 'timeFrame': '3 month', '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'}, {'measure': 'Estimate the decrease in surgical complications', 'timeFrame': '1 month', 'description': 'Report all surgical complications (Grade \\> 1 according to Clavien Dindo classification) up to 1 month after surgery'}, {'measure': 'Evaluate the efficacy of interventions on patient depression and anxiety', 'timeFrame': '12 months', 'description': 'Patient Depression and anxiety will be evaluated by using the Hospital Anxiety and Depression Scale (HADS)'}, {'measure': 'Evaluate the efficacy of interventions on patient quality of life', 'timeFrame': '12 months', 'description': 'Patient quality of life will be evaluated by using the Quality of Life Questionnaire (QLQ-C30)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smoking Cessation', 'Motivational Interviewing (MI)', 'Cognitive Behavioural Therapy (CBT)', 'Hypnotherapy', 'Nicotine Replacement Therapy (NRT)', 'Surgery', 'Surgery complications', 'longitudinal cohort'], 'conditions': ['Breast Cancer', 'Gynecologic Cancer', 'Digestive Cancer', 'Melanoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAll 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.\n\nSmoking assessment, exhaled CO measurement, questionnaires will be completed regularly to assess depression, anxiety and quality of life during the 12 months.\n\nPatients 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.\n\nPatients randomized in group 4 will receive 1 to 3 MI and at least 3 sessions oh hypnotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Smoking patient: daily tobacco consumption.\n* Patient with cancer requiring surgical treatment (breast cancer, digestive cancer, gynecological).\n* Patient wishing to quit smoking.\n* Fagerström \\> 3.\n* Patient has valid health insurance\n* Information and agreement of the patient to participate in the longitudinal cohort.\n* Signing of specific informed consent for patients in groups 1 to 4 before any study-related intervention.\n* Person able to speak, read and understand French.\n\nExclusion Criteria:\n\n* Patient not receiving surgical treatment.\n* Refusal to participate in the longitudinal cohort study.\n* Pregnant or likely to be pregnant or nursing patient.\n* Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian\n* disability to undergo the medical follow-up of the trial for geographical, social or psychological reasons.'}, 'identificationModule': {'nctId': 'NCT04899492', 'acronym': 'RESPIRE', 'briefTitle': 'Evaluation of Different Smoking Cessation Protocols: Nicotine Replacement, Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy in Cancer Patients Scheduled for Surgery', 'organization': {'class': 'OTHER', 'fullName': "Institut Cancerologie de l'Ouest"}, 'officialTitle': 'Pilot Study in Cancer Patients Scheduled for Surgery Evaluating Different Smoking Cessation Protocols : Nicotine Replacement, Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy', 'orgStudyIdInfo': {'id': 'ICO-2020-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1:Nicotine Replacement Therapy (NRT)', 'description': 'Patients enrolled in group 1 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study', 'interventionNames': ['Drug: Nicotine Replacement Therapy (NRT)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2:Motivational Interviewing (MI)', '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', 'interventionNames': ['Behavioral: Motivational Interviewing (MI)', 'Drug: Nicotine Replacement Therapy (NRT)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3:Cognitive Behavioural Therapy (CBT)', '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', 'interventionNames': ['Behavioral: Motivational Interviewing (MI)', 'Behavioral: Cognitive Behavioural Therapy (CBT)', 'Drug: Nicotine Replacement Therapy (NRT)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4: Hypnotherapy', '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', 'interventionNames': ['Behavioral: Motivational Interviewing (MI)', 'Behavioral: Hypnotherapy', 'Drug: Nicotine Replacement Therapy (NRT)']}], 'interventions': [{'name': 'Motivational Interviewing (MI)', 'type': 'BEHAVIORAL', 'description': '1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist', 'armGroupLabels': ['Group 2:Motivational Interviewing (MI)', 'Group 3:Cognitive Behavioural Therapy (CBT)', 'Group 4: Hypnotherapy']}, {'name': 'Cognitive Behavioural Therapy (CBT)', 'type': 'BEHAVIORAL', 'description': '6 Cognitive Behavioural Therapy (CBT) sessions should be performed after motivational interviewing up to 6 months by a psychotherapist', 'armGroupLabels': ['Group 3:Cognitive Behavioural Therapy (CBT)']}, {'name': 'Hypnotherapy', 'type': 'BEHAVIORAL', 'description': 'About 3 Hypnotherapy sessions should be performed after motivational interviewing up to 6 months by a hypnotherapist', 'armGroupLabels': ['Group 4: Hypnotherapy']}, {'name': 'Nicotine Replacement Therapy (NRT)', 'type': 'DRUG', 'description': 'All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months', 'armGroupLabels': ['Group 1:Nicotine Replacement Therapy (NRT)', 'Group 2:Motivational Interviewing (MI)', 'Group 3:Cognitive Behavioural Therapy (CBT)', 'Group 4: Hypnotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44805', 'city': 'Saint-Herblain', 'country': 'France', 'facility': "Institut de Cancerologie de l'Ouest (ICO)", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Cancerologie de l'Ouest", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}