HR-QOL in Colorectal Cancer Survivors with Stomas

描述(由申请人提供)：此申请是我们正在进行的研究资助(R01 CA106912)的5年竞争续期申请，HR-QOL在有造口的结直肠癌(CRC)幸存者中的应用。这项研究比较了287名结直肠癌患者(5年)和395名未做造口的结直肠癌患者。主要发现包括对造口者用来控制肠道功能的多重行为和饮食适应的更好理解；这些患者面临的以前未被报道的并发症；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)评估工作残疾的关键问题，(3)评估行为和饮食调整，以及(4)增加对少数族裔结果的了解。具体目的1：了解决定浸润性直肠癌长期存活者预后的因素及相关治疗，包括(A)永久性造口，(B)不作临时造口的吻合术，和(C)临时造口的吻合术(表明低位肿瘤仅有最少的直肠残存)。要测量的结果包括肠功能、HR-QOL、工作残疾和医疗并发症。具体目标2：从初次肿瘤手术为吻合术的患者中，评估肿瘤部位、患者年龄和合并发病率与吻合口失败率和最终永久造口的关系。具体目标3：为了更好地了解直肠癌幸存者通过造口和吻合来控制肠道功能所做的行为和饮食调整的范围。具体目标4：收集定性数据，以便更全面地了解少数直肠癌幸存者的生活经历。这项研究将以2724名直肠癌长期幸存者为研究对象，其中142人是黑人/非裔美国人，209人是西班牙裔/拉丁裔，340人是亚洲/太平洋岛民。数据将使用邮寄问卷的患者自我报告信息、与电子病历的链接、焦点小组和深入访谈来收集。这项研究在确定最大的直肠癌长期幸存者群体进行研究方面具有创新性。通过这项拟议的研究，我们可以更好地了解直肠癌治疗的风险和好处，以及患者为改善对其肠道功能的控制而做出的适应。公共卫生相关性：这是对我们正在进行的研究资助(R01 CA106912)的竞争性更新，“结肠直肠癌幸存者有造口的HR-QOL”提出了一项针对直肠癌幸存者的研究，使用焦点小组和邮寄问卷。与健康相关的生活质量、工作残疾、行为和饮食适应、医疗费用和长期医疗并发症将被衡量。这项研究将加强关于直肠癌现有手术选择的结果的证据基础：永久性造口和保留直肠的手术。对结果的更多了解将使患者和他们的医生在考虑可用的手术选择时能够更充分地了解情况，还将有助于开发临床和自助干预措施，并在当前的护理算法中潜在的质量改进。

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. Public Health Relevance: This competitive renewal to our ongoing research grant (R01 CA106912), "HR-QOL in Colorectal Cancer Survivors with Stomas" proposes a study of rectal cancer survivors using focus groups and mailed questionnaires. Health-related quality of life, work disability, behavioral and dietary adaptations, healthcare costs and long-term medical complications will be measured. The study will strengthen the evidence base regarding outcomes resulting from the surgical options now available for rectal cancer: permanent ostomy and rectal-sparing surgery. Greater knowledge of outcomes will enable patients and their physicians to be more fully informed at the time they are considering their available surgical options and will also enable development of clinical and self-help interventions and potential quality improvements in the current algorithms for care.