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腺X线摄影的广泛使用而增加。虽然有相当多的研究对生活质量（QOL）的妇女与浸润性乳腺癌，有关于生活质量的妇女与DCIS很少，也没有纵向生活质量研究比较妇女与DCIS，妇女与早期（阶段I和II）乳腺癌，和妇女没有乳腺癌。因此，本研究将描述和比较这三组妇女的生活质量。具体目的是：1）描述DCIS女性随时间推移的QOL特征，2）确定DCIS和早期乳腺癌患者与健康对照之间随时间推移的QOL差异，3）从基线评估的人口统计学、临床和心理社会因素中确定DCIS女性的QOL预测因子。DCIS和乳腺癌患者将由合作外科医生前瞻性识别。将在筛选时前瞻性确定乳房X线检查正常或良性的女性，并在按年龄组（40-49岁、50-69岁和70岁以上）与患者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）签署的招募信将与知情同意书一起邮寄，并随后通过电话回答问题。获得知情同意后，将在术后1个月、6个月、1年和2年（患者）或筛查乳房X线检查后（对照组）进行电话访视，以收集数据。癌症治疗功能评估-乳腺（FACT-B）将用于比较DCIS和早期乳腺癌女性的QOL，兰德36项健康调查1.0将用于比较健康对照与DCIS和早期乳腺癌女性之间的QOL。此外，还将收集可能是生活质量重要预测因素的人口统计学、临床和心理社会因素的相关数据。将使用广义估计方程检验三组间随时间推移的QOL差异。多水平模型，考虑到纵向的研究方法，将确定三组之间的生活质量的预测。这项研究的结果可能会导致如何改善被诊断为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.