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lack of patient enrolment
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| Name | Class |
|---|---|
| National Cancer Institute, France | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1:Nicotine Replacement Therapy (NRT) | Active Comparator | Patients enrolled in group 1 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study |
|
| Group 2:Motivational Interviewing (MI) | Experimental | 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 |
|
| Group 3:Cognitive Behavioural Therapy (CBT) | Experimental | 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 |
|
| Group 4: Hypnotherapy | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Interviewing (MI) | Behavioral | 1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Evaluate the efficacy of the following interventions for smoking cessation in French cancer patients: MI, CBT and Hypnotherapy, combined with nicotine replacement therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancerologie de l'Ouest (ICO) | Saint-Herblain | 44805 | France |
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pilot study, monocentric, prospective, randomization according to Zelen's design
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| Cognitive Behavioural Therapy (CBT) | Behavioral | 6 Cognitive Behavioural Therapy (CBT) sessions should be performed after motivational interviewing up to 6 months by a psychotherapist |
|
| Hypnotherapy | Behavioral | About 3 Hypnotherapy sessions should be performed after motivational interviewing up to 6 months by a hypnotherapist |
|
| Nicotine Replacement Therapy (NRT) | Drug | All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months |
|
Percentage of patients reporting no smoking during the last 7 days before the visit. |
| 12 months |
| Evaluate the efficacy of the different interventions in reducing tobacco consumption | Number of cigarettes smoked per day from baseline | 12 months |
| Evaluate the efficacy of the different interventions in terms of continued abstinence since surgery | Percentage of patients reporting no smoking since surgery | 12 months |
| 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 |
| 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 |
| 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 |
| 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 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 22, 2026 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D008545 | Melanoma |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| D015928 | Cognitive Behavioral Therapy |
| D006990 | Hypnosis |
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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