Skin Toxicity Effects in Breast Radiation: A Cognitive Behavioral Intervention

描述(由申请者提供)：目标：NCI挑战赛2015年的目标是消除癌症带来的痛苦。放射治疗所致皮肤毒性对乳腺癌患者生活质量的多个维度均有显著不良影响。这项职业发展奖提案的长期目标在两个方面与NCI挑战目标一致：1)为候选人提供必要的培训，使其成为一名独立的癌症预防和控制研究人员，专门研究放射治疗对患者生活质量的影响；以及2)开发和测试一种认知-行为干预措施，以对抗急性皮肤毒性对乳腺癌放射治疗患者生活质量(QOL)的影响。具体目的：1)采用定性研究方法，全面评估和记录放疗引起的皮肤毒性对乳腺癌放疗患者生活质量的影响。2)根据AIM 1的研究结果，探讨包括认知行为治疗和催眠(CBT H)在内的行为医学干预对乳腺癌放射治疗患者皮肤毒性的影响。3)探讨社会心理因素在CBT催眠干预有益影响的中介和调节中的作用。关键的中介和调节因素包括：社会因素(工作联盟、人际互补性)、心理因素(痛苦、反应预期)和催眠性。研究设计和方法：目的1：乳腺癌放射治疗患者(N=20)将参加个别定性访谈和焦点小组，以了解皮肤毒性如何影响他们的生活质量。将使用主题和话语分析方法。目标2和目标3将使用随机对照试验方法进行，以比较催眠认知行为干预(CBT H)和注意力控制(AC)在改善皮肤毒性相关生活质量方面的作用。144名乳腺癌放射治疗患者将被随机分配到组，在放射治疗期间和之后的一个月内进行评估。公共卫生相关性：首先，该奖项将产生一名专注于放射治疗的高素质癌症预防和控制研究人员。其次，该提案将测试一种新的干预措施，有可能改善所有接受放射治疗的乳腺癌患者的生活质量，从行为医学的角度来看，这是一个经常被忽视的群体。

DESCRIPTION (provided by applicant): Objective: The NCI Challenge Goal 2015 is to eliminate suffering due to cancer. Radiotherapy induced skin toxicity has significant adverse effects on multiple dimensions of breast cancer patients' quality of life. The long- term objective of this Career Development Award proposal is consistent with the NCI Challenge Goal in two ways: 1) providing the necessary training for the candidate to become an independent cancer prevention and control researcher specializing in the effects of radiotherapy on patients' quality of life; and 2) to develop and test a cognitive-behavioral intervention to combat the effects of acute skin toxicity on breast cancer radiotherapy patients' quality of life (QOL). Specific Aims: 1) To use qualitative research methods to thoroughly assess and document the effects of radiotherapy-induced skin toxicity on quality of life of breast cancer radiotherapy patients. 2) To investigate the impact of a behavioral medicine intervention, including cognitive-behavioral therapy and hypnosis (CBT+H), informed by the results of Aim 1, on the effects of skin toxicity in breast cancer radiotherapy patients. 3) To explore the role of social and psychological factors in the mediation and moderation of the beneficial impact of the CBT+Hypnosis intervention. Key mediators and moderators include: social factors (working alliance, interpersonal complementarity), psychological factors (distress, response expectancies) and hypnotizability. Research Design and Methods: Aim 1: Breast cancer radiotherapy patients (N=20) will participate in individual qualitative interviews and focus groups to learn how skin toxicity has affected their QOL. Thematic and discursive analytic approaches will be used. Aims 2 and 3 will be carried out using RCT methodology to compare a cognitive-behavioral intervention with hypnosis (CBT+H) to attention control (AC) with regard to improvements in skin toxicity-related QOL. 144 breast cancer radiotherapy patients will be randomly assigned to group, and assessments will be administered during, and for one month following, radiotherapy. Public Health Relevance: First, the award will produce a highly qualified cancer prevention and control researcher with a focus on radiotherapy. Second, the proposal will test a new intervention with the potential to improve the quality of life of all breast cancer patients undergoing radiotherapy, an often ignored group from the behavioral medicine perspective.