Quality of Life Over Time: DCIS vs Early Breast Cancer

描述(申请人提供)：随着筛查乳房X光检查的广泛应用，乳腺导管原位癌(DCIS)的诊断有所增加。尽管关于浸润性乳腺癌妇女的生活质量(QOL)有相当多的研究，但与DCIS妇女的生活质量相关的研究很少，也没有纵向的QOL研究比较DCIS妇女、早期(I期和II期)乳腺癌妇女和非乳腺癌妇女。因此，本研究将描述和比较这三组女性的生活质量。其具体目的是：1)描述DCIS患者随时间推移的生活质量的特征；2)确定DCIS、早期乳腺癌患者和健康对照之间随时间变化的生活质量差异；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女性患者生活质量的预测因素。DCIS和乳腺癌患者将由合作的外科医生进行前瞻性识别。乳腺X光检查正常或良性的妇女将在筛查时进行前瞻性鉴定，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。由合作的外科医生或放射科医生(对照)签署的招聘信将与同意书一起邮寄，并随后通过电话回答问题。在同意后，将在手术后1个月、6个月、1年和2年后(患者)或筛查乳房X光检查后(对照)使用电话采访来收集数据。癌症治疗-乳腺癌功能评估(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，还将收集有关人口统计、临床和心理社会因素的数据，这些因素可能是生活质量的重要预测因素。随着时间的推移，将使用广义估计方程来检验三组人之间的生活质量差异。考虑到研究的纵向方法的多水平模型将在三组中确定生活质量的预测因素。这项研究的发现可能会导致改善被诊断为DCIS的妇女的生活质量的方法。

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.