Quality of Life Over Time: DCIS vs Early Breast Cancer

描述（由申请人提供）：乳腺导管原位癌（DCIS）的诊断随着筛查性乳房x光检查的广泛使用而增加。虽然关于浸润性乳腺癌妇女的生活质量（QOL）的研究相当多，但关于DCIS妇女的生活质量的研究很少，并且没有对DCIS妇女、早期（I期和II期）乳腺癌妇女和非乳腺癌妇女的生活质量进行纵向研究。因此，本研究将描述和比较这三组女性的生活质量。具体目的是：1)描述DCIS患者的生活质量随时间变化的特征；2)确定DCIS患者、早期乳腺癌患者和健康对照者的生活质量随时间变化的差异；3)从基线评估的人口统计学、临床和社会心理因素中确定DCIS患者生活质量的预测因素。DCIS和乳腺癌患者将通过合作外科医生进行前瞻性识别。在筛查时，对乳房x线检查正常或良性的女性进行前瞻性识别，并按年龄组（40-49岁、50-69岁、70岁以上）与患者进行匹配后随机选择为对照组。由合作外科医生或放射科医生（对照组）签署的招募信将与同意书一起邮寄，并随后致电回答问题。同意后，在手术后1个月、6个月、1年和2年（患者）或筛查乳房x光检查后（对照组）进行电话访谈收集数据。肿瘤治疗-乳腺功能评估（FACT-B）将用于比较DCIS和早期乳腺癌妇女的生活质量，RAND 36项健康调查1.0将用于比较健康对照组和DCIS和早期乳腺癌妇女的生活质量。此外，将收集可能是生活质量重要预测因素的人口统计学、临床和社会心理因素的数据。三组间生活质量随时间的差异将使用广义估计方程进行检验。考虑到研究的纵向方法的多层次模型将确定三组中生活质量的预测因子。本研究的发现可能有助于改善诊断为DCIS的女性的生活质量。

DESCRIPTION (provided by applicant): Diagnosis of ductal carcinoma in situ (DCIS) of the breast has increased with more widespread use of screening mammography. Although there is considerable research about quality of life (QOL) in women with invasive breast cancer, there is little pertaining to QOL in women with DCIS, and there are no longitudinal QOL studies comparing women with DCIS, women with early-stage (Stages I and II) breast cancer, and women without breast cancer. Therefore, this study will describe and compare QOL among these three groups of women. The specific aims are to 1) characterize the QOL of women with DCIS over time, 2) Identify differences in the QOL over time among DCIS and early-stage breast cancer patients and healthy controls, and 3) identify predictors of QOL among women with DCIS from among demographic, clinical, and psychosocial factors assessed at baseline. DCIS and breast cancer patients will be identified prospectively by collaborating surgeons. Women with normal or benign mammograms will be identified prospectively at I time of screening and randomly selected for the control group after being matched by age group (40-49, 50-69, and 70+) with the patients. Recruitment letters signed by the collaborating surgeons or radiologist (controls) will be mailed with consent forms and followed up with a telephone call to answer questions. Following consent, telephone interviews at 1 month, 6 months, 1 year, and 2 years after surgery (patients) or after a screening mammogram (controls) will be used to collect data. The Functional Assessment of Cancer Therapy-Breast (FACT-B) will be used to compare QOL of women with DCIS and early breast cancer and the RAND 36-Item Health Survey 1.0 wilt be used to compare the QOL between healthy controls and women with DCIS and early breast cancer. In addition, data about demographic, clinical, and psychosocial factors that may be important predictors of QOL will be collected. Differences in QOL among the three groups over time will be tested using generalized estimating equations. Multi-level models, which take into account the longitudinal approach of the study, will identify predictors of QOL among the three groups. Findings from this study may lead to ways to improve the QOL of women diagnosed with DCIS.