Intensive Smoking Cessation Invervention for Head and Neck Cancer Patients

描述(由申请人提供)：烟草是头颈部癌症的主要危险因素。有证据表明，确诊后继续吸烟的头颈部癌症患者患第二原发癌、复发、对治疗的反应降低和生存率下降的风险增加。尽管有很高比例的头颈部患者在确诊后戒烟，但M.D.安德森癌症中心(MDACC)烟草治疗计划(TTP)和其他研究的数据表明，28%至46%的患者继续吸烟。MDACC TTP和其他研究的数据还表明，在确诊后继续吸烟的头颈癌患者中，有很高比例的人存在各种因素，这些因素可能会使他们的戒烟努力复杂化，包括高度尼古丁依赖、与癌症有关的高水平情绪困扰，以及共病的抑郁、焦虑和酒精使用障碍。这表明，这一亚群的患者可能需要更有效地解决这些戒烟障碍的强化治疗。这项研究的目标是为确诊后继续吸烟的头颈部患者开发基于接受和承诺疗法(ACT)的强化戒烟干预，ACT是一种已被发现在治疗癌症患者吸烟、物质依赖障碍和痛苦方面有效的现有治疗方法；进行一项小型初步随机试验，以检验其对短期和长期时点患病率和长期戒烟的影响，以及与现有动机和行为戒烟治疗(MBC)相关的生活质量；并且，评估ACT假想的治疗机制是否中介ACT对禁欲的影响，以及这些介体是否与调节MBC对禁欲的影响的变量不同。该项目将分两个阶段进行。在第一阶段(第Ia阶段)，我们将修改现有接受和承诺疗法治疗方案的内容，作为头颈部确诊后继续吸烟的患者的戒烟干预措施。在这一阶段，通过MDACC TTP招募的20名头颈部患者将完成该方案，该方案将根据患者、ACT治疗专家和研究治疗师的反馈进行修改和完善。在第二阶段(第Ib阶段)，67名确诊后继续吸烟的头颈部患者将通过MDACC TTP招募，并随机分配到ACT或TTP标准MBC治疗。在这两种情况下，都将包括varenicline作为治疗的一部分。根据这项初步试验的结果，ACT治疗方案将进一步完善，并为更大规模的临床试验做好准备。公共卫生相关性：这项研究的目标是为确诊后继续吸烟的头颈部患者开发一种强化戒烟干预措施，并提供其有效性的初步信息。接受与承诺疗法(ACT)是一种现有的治疗方法，已被发现在治疗癌症患者的物质使用障碍和痛苦方面是有效的。我们将修改和开发这种治疗方法，将其作为戒烟干预措施，然后进行一项小型试验，看看与目前可用的咨询治疗相比，ACT是否在帮助头颈部癌症患者戒烟和提高他们的生活质量方面更有效。如果ACT被发现更有效，它可能会在更大的研究中进一步测试。

DESCRIPTION (provided by applicant): Tobacco is a primary risk factor for cancers of the head and neck. There is evidence that patients with head and neck cancer who continue to smoke following diagnosis are at increased risk for developing second primary tumors, recurrence, reduced response to treatment, and reduced survival. Although a high percentage of head and neck patients abstain from smoking following diagnosis, data from the M.D. Anderson Cancer Center (MDACC) Tobacco Treatment Program (TTP) and other studies suggest that 28 percent to 46 percent of patients continue to smoke. Data from the MDACC TTP and other studies also indicate that a high proportion of head and neck cancer patients who continue to smoke following diagnosis present with a variety of factors that may complicate their efforts to quit, including high levels of nicotine dependence, high levels of emotional distress related to their cancer, and comorbid depressive, anxiety and alcohol use disorders. This suggests that this subpopulation of patients may need an intensive treatment that more effectively addresses these barriers to cessation. The goals of this study are to develop an intensive smoking cessation intervention for head and neck patients who continue to smoke following diagnosis that is based on Acceptance and Commitment Therapy (ACT), an existing treatment that has been found to be efficacious in the treatment of smoking, substance dependence disorders, and distress in cancer patients; to conduct a small preliminary randomized trial to examine its effects on both short and long-term point prevalence and prolonged abstinence, and quality of life relative to an existing motivational and behavioral smoking cessation treatment (MBC); and, to evaluate whether ACT's hypothesized treatment mechanisms mediate ACT's effect on abstinence and whether these mediators differ from variables that mediate MBC's effect on abstinence. The project will take place in two phases. In the first phase (Stage Ia), we will modify content from existing Acceptance and Commitment Therapy treatment protocols for use as a smoking cessation intervention for head and neck patients who continue to smoke following diagnosis. During this phase, 20 head and neck patients recruited through the MDACC TTP, will complete the protocol, which will be modified and refined based upon feedback from patients, ACT treatment experts, and study therapists. In the second phase (Stage Ib), 67 head and neck patients who continue to smoke following diagnosis will be recruited through the MDACC TTP and randomly assigned to either ACT or the TTP standard MBC treatment. Varenicline will be included as part of treatment in both conditions. Based on the outcome of this preliminary trial, the ACT treatment protocol will be further refined and readied for larger-scale clinical trials. PUBLIC HEALTH RELEVANCE: The goal of this study is to develop an intensive smoking cessation intervention for head and neck patients who continue to smoke following diagnosis, and to provide preliminary information about its effectiveness. Acceptance and Commitment Therapy (ACT) is an existing treatment that has been found to be effective in the treatment of substance use disorders and distress in cancer patients. We will modify and develop this treatment as a smoking cessation intervention and then run a small trial to see whether ACT is more effective in helping head and neck cancer patients quit and in improving their quality of life, compared to the currently available counseling treatment. If ACT is found to be more effective, it could be further tested in larger studies.