Skin Toxicity Effects in Breast Radiation: A Cognitive Behavioral Intervention

描述（由申请人提供）：目的：2015年NCI挑战目标是消除癌症带来的痛苦。放疗引起的皮肤毒性对乳腺癌患者生活质量的多个维度都有显著的不良影响。该职业发展奖提案的长期目标与NCI挑战目标在两个方面是一致的：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，专门研究放疗对患者生活质量的影响；2)开发和测试一种认知行为干预，以对抗急性皮肤毒性对乳腺癌放疗患者生活质量的影响。具体目的：1)采用定性研究方法，全面评估和记录放疗所致皮肤毒性对乳腺癌放疗患者生活质量的影响。2)探讨行为医学干预，包括认知行为治疗和催眠（CBT+H），根据Aim 1的结果，对乳腺癌放疗患者皮肤毒性的影响。3)探讨社会心理因素在CBT+催眠干预有益影响中的中介和调节作用。主要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（困扰、反应期望）和可催眠性。研究设计与方法：目的1：对20例乳腺癌放疗患者进行个体定性访谈和焦点小组访谈，了解皮肤毒性对其生活质量的影响。将使用主题和话语分析方法。目的2和3将采用随机对照试验方法，比较认知行为干预与催眠（CBT+H）和注意控制（AC）在改善皮肤毒性相关生活质量方面的效果。144例乳腺癌放疗患者将被随机分为两组，在放疗期间和放疗后一个月进行评估。公共卫生相关性：首先，该奖项将培养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，它有可能改善所有接受放疗的乳腺癌患者的生活质量，这是一个从行为医学角度经常被忽视的群体。

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.