Developing a Skin Toxicity-Related Quality of Life Scale for Breast Radiotherapy

描述（由申请人提供）：2010年预计将有超过20万女性被诊断为乳腺癌，其中约一半将接受放疗，以延长生存期和改善局部肿瘤控制。绝大多数乳腺癌放疗患者（74%-100%）在治疗期间会出现皮肤毒性。皮肤毒性的物理表现包括红斑（发红、发热、皮疹样外观）、干性脱屑（干燥、瘙痒、脱皮）、湿性脱屑（渗出、触痛、发红、暴露真皮层）和坏死。严重的皮肤毒性甚至需要中断治疗，这可能会减少局部疾病的控制，并增加总体死亡率。皮肤毒性可以影响生活质量（QOL）的多个方面，包括感觉（疼痛、瘙痒、灼烧）、身体形象、情绪健康、生活方式和治疗满意度。尽管皮肤毒性普遍存在，但尚无衡量皮肤毒性相关生活质量（STR-QOL）的金标准。缺乏STR-QOL的测量是一个严重的问题，至少有三个原因：1)如果没有一个健全的评估工具，患者经历的重要临床方面可能无法被识别和管理；2)如果不能准确了解放疗的副作用和对生活质量的影响，乳腺癌患者无法做出充分知情的治疗决策；3)为了严格评估预防和控制皮肤毒性的新策略和干预措施，需要一个可靠、有效和反应灵敏的量表。如果没有这样一个尺度，皮肤毒性预防和控制工作的效果将很难，如果不是不可能，解释。因此，与NIH路线图对“迫切需要更好地量化临床重要症状和结果”的认识一致，该项目的目标是产生第一个心理测量学上合理且临床有意义的量表来评估乳腺癌放疗患者的STR-QOL -皮肤毒性-乳房（POST-B）。该项目的第一个具体目标是从我们的初步项目池的构建块中组装POST-B。使用最先进的心理测量方法（项目反应理论），我们将减少111个初步项目，以产生最终的、简洁的、心理测量上合理的量表，在最大限度地减少患者负担的同时获得最大的信息。第二个具体目标是确定POST-B的可靠性和有效性。第三个具体目标是确定POST-B的响应性（对变化的敏感性）。该研究的结果有可能增加我们对皮肤毒性患者经历的理解，改善临床环境中的症状评估和管理，并为皮肤毒性预防和控制的临床试验提供急需的结果测量。

DESCRIPTION (provided by applicant): Over 200,000 women are expected to be diagnosed with breast cancer in 2010, and approximately half will receive radiotherapy to prolong survival and improve localized tumor control. The vast majority of breast cancer radiotherapy patients (74%-100%) will experience skin toxicity during treatment. The physical manifestations of skin toxicity range from erythema (redness, warmth, rash-like appearance), to dry desquamation (dryness, itching, peeling), moist desquamation (oozing, tender, redness and exposure of the dermis), and necrosis. Severe skin toxicity can even necessitate treatment breaks, which can reduce local disease control and increase overall mortality. Skin toxicity can affect multiple aspects of quality of life (QOL) including sensation (pain, itching, burning), body image, emotional well-being, lifestyle, and treatment satisfaction. Despite the prevalence of skin toxicity, there is no gold standard measure of skin toxicity-related quality of life (STR-QOL). The lack of a measure of STR-QOL is a serious concern for at least three reasons: 1) without a sound assessment tool, important clinical aspects of patients' experiences may go unrecognized and unmanaged; 2) breast cancer patients cannot make fully informed treatment decisions without accurate information on radiotherapy side effects and effects on QOL; and 3) a reliable, valid, and responsive scale is needed in order to rigorously evaluate new strategies and interventions to prevent and control skin toxicity. Without such a scale, the efficacy of skin toxicity prevention and control efforts will be difficult, if not impossible, to interpret. Therefore, consistent with the NIH Roadmap's recognition of the "pressing need to better quantify clinically important symptoms and outcomes," the goal of the project is to produce the first psychometrically sound and clinically meaningful scale to assess STR-QOL in breast cancer radiotherapy patients - the Profile of Skin Toxicity-Breast (POST-B). The first specific aim of the project is to assemble the POST-B from the building blocks of our preliminary item pool. Using state-of-the-art psychometric approaches (item response theory), we will reduce the 111 preliminary items to yield a final, concise, psychometrically sound scale that maximizes information gained while minimizing patient burden. The second specific aim is to determine the reliability and validity of the POST-B. The third specific aim is to determine the responsiveness (sensitivity to change) of the POST-B. Results of the proposed study have the potential to increase our understanding of the patient experience of skin toxicity, to improve symptom assessment and management in clinical settings, and to provide a much needed outcome measure for clinical trials of skin toxicity prevention and control efforts.