Pilot Study in Cancer Patients Scheduled for Surgery Evaluating Different Smoking Cessation Protocols : Nicotine Replacement (NRT), Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Testing the Feasibility of Smoking Cessation Interventions Evaluated in French Cancer Patients Undergoing Surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 >
- •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.
排除标准
- •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.
研究组 & 干预措施
Group 2:Motivational Interviewing (MI)
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
干预措施: Motivational Interviewing (MI) (Behavioral)
Group 3:Cognitive Behavioural Therapy (CBT)
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
干预措施: Motivational Interviewing (MI) (Behavioral)
Group 3:Cognitive Behavioural Therapy (CBT)
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
干预措施: Cognitive Behavioural Therapy (CBT) (Behavioral)
Group 4: Hypnotherapy
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
干预措施: Motivational Interviewing (MI) (Behavioral)
Group 3:Cognitive Behavioural Therapy (CBT)
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
干预措施: Nicotine Replacement Therapy (NRT) (Drug)
Group 2:Motivational Interviewing (MI)
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
干预措施: Nicotine Replacement Therapy (NRT) (Drug)
Group 1:Nicotine Replacement Therapy (NRT)
Patients enrolled in group 1 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study
干预措施: Nicotine Replacement Therapy (NRT) (Drug)
Group 4: Hypnotherapy
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
干预措施: Nicotine Replacement Therapy (NRT) (Drug)
Group 4: Hypnotherapy
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
干预措施: Hypnotherapy (Behavioral)
结局指标
主要结局
Testing the Feasibility of Smoking Cessation Interventions Evaluated in French Cancer Patients Undergoing Surgery
时间窗: 12 months
Number of patients who completed all planned sessions out of the total number of patients randomised to each group
次要结局
未报告次要终点