HR-QOL in Colorectal Cancer Survivors with Stomas

描述（由申请人提供）：本申请是对我们正在进行的研究资助（R 01 CA 106912）的5年竞争性更新的请求，结肠直肠癌（CRC）造口幸存者的HR-QOL。该研究比较了287例接受造口术的CRC幸存者（>5年）和395例未接受造口术的CRC幸存者。关键发现包括更好地了解造口者用于控制肠功能的多种行为和饮食适应;这些患者面临的先前报道不足的并发症;以及男性和女性的HR-QOL差异。更新的重点是直肠癌，有四个关键目标：（1）加强所有主要直肠癌手术后结果的证据基础，（2）评估工作障碍的关键问题，（3）评估行为和饮食调整，（4）增加少数民族的结果知识。具体目标1：了解浸润性直肠癌和相关治疗的所有长期生存者结局的决定因素，包括（a）永久性造口术，（B）无临时造口术的吻合术，和（c）临时造口术的吻合术（表明低位癌，残留直肠最少）。要测量的结局包括肠功能、HR-QOL、工作残疾和医疗并发症。具体目标二：在初次癌症手术为吻合术的患者中，评估肿瘤位置、患者年龄和合并症与吻合失败率和最终永久性造口术的关系。具体目标3：为了更好地了解直肠癌幸存者的行为和饮食调整的范围与造口术和吻合术，以控制肠功能。具体目标4：收集定性数据，以更全面地了解少数直肠癌幸存者的生活经历。该研究将在2，724名直肠癌长期幸存者中进行，其中142名为黑人/非裔美国人，209名为西班牙裔/拉丁裔，340名为亚洲/太平洋岛民。将通过邮寄问卷、电子病历链接、焦点小组和深入访谈收集患者自我报告的信息。这项研究在确定最大的长期直肠癌幸存者群体方面具有创新性。通过这项研究，我们可以更好地了解直肠癌治疗的风险和益处，以及患者为改善肠道功能控制所做的调整。

DESCRIPTION (provided by applicant): This application is a request for a 5-year competitive renewal of our ongoing research grant (R01 CA106912), HR-QOL in Colorectal Cancer (CRC) Survivors with Stomas. The study compared 287 CRC survivors (>5 years) with ostomy with 395 CRC survivors without ostomy. Key findings include a greater understanding of the multiple behavioral and dietary adaptations ostomates use to control bowel function; the previously under- reported complications these patients face; and the HR-QOL differences for men and women. The renewal is focused on rectal cancer and has four critical goals: (1) strengthen the evidence base on outcomes following all major rectal cancer procedures, (2) assess the key question of work disability, (3) assess behavioral and dietary adjustments, and (4) increase knowledge of outcomes in minorities. Specific Aim 1: To understand the determinants of outcomes in all long-term survivors of invasive rectal cancer and associated treatments, including those with (a) permanent ostomy, (b) anastomosis without temporary ostomy, and (c) anastomosis with temporary ostomy (indicating low cancers with minimal remaining rectum). Outcomes to be measured include bowel function, HR-QOL, work disability, and medical complications. Specific Aim 2: From among patients whose initial cancer surgery was anastomosis, to assess the relationships of tumor location, patient age, and co-morbidity on the rate of anastomotic failure and eventual permanent ostomy. Specific Aim 3: To better understand the scope of behavioral and dietary adjustments made by rectal cancer survivors with ostomy and anastomosis to control bowel function. Specific Aim 4: To collect qualitative data to more fully understand the lived experiences of minority rectal cancer survivors. The study will be set among 2,724 long-term survivors with rectal cancer, of whom 142 are Black/African American, 209 are Hispanic/Latino, and 340 are Asian/Pacific Islander. Data will be collected using patient self-reported information to a mailed questionnaire, linkage to the electronic medical record, focus groups, and in-depth interviews. The study is innovative in identifying the largest group of long-term rectal cancer survivors for study. Through the proposed study, we can better understand the risks and benefits of rectal cancer treatments as well as the adaptations patients make to improve control of their bowel functioning.