HR-QOL in Colorectal Cancer Survivors with Stomas

描述（由申请人提供）：本申请是我们正在进行的研究资助（R01 CA106912）的5年竞争性续期申请，研究结直肠癌（CRC）生存幸存者的HR-QOL。该研究比较了287例（50 ~ 5年）行造口术的结直肠癌幸存者和395例未行造口术的结直肠癌幸存者。主要发现包括：对口气孔动物用于控制肠道功能的多种行为和饮食适应有了更深入的了解；这些患者所面临的先前未被报道的并发症；男性和女性的HR-QOL差异。更新的重点是直肠癌，并有四个关键目标：(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)增加对少数群体结果的了解。具体目标1：了解侵袭性直肠癌和相关治疗的所有长期幸存者预后的决定因素，包括(a)永久性造口术，(b)无临时造口吻合，(c)临时造口吻合（表明低癌，剩余直肠最少）。测量的结果包括肠功能、HR-QOL、工作残疾和医疗并发症。特异性目的2：从初始肿瘤手术为吻合的患者中，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的关系。具体目的3：更好地了解行造口吻合术的直肠癌幸存者控制肠功能的行为和饮食调整范围。具体目的4：收集定性数据，以更全面地了解少数民族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名是黑人/非裔美国人，209名是西班牙裔/拉丁裔，340名是亚洲/太平洋岛民。数据将通过邮寄问卷、与电子病历的联系、焦点小组和深度访谈等方式收集。这项研究的创新之处在于确定了最大的长期直肠癌幸存者群体进行研究。通过提出的研究，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而做出的适应。公共卫生相关性：这是我们正在进行的研究资助（R01 CA106912）的竞争性更新，“结直肠癌生存幸存者的HR-QOL”建议使用焦点小组和邮寄问卷对直肠癌幸存者进行研究。将测量与健康有关的生活质量、工作残疾、行为和饮食适应、医疗保健费用和长期医疗并发症。该研究将加强关于目前可用于直肠癌的手术选择结果的证据基础：永久造口术和直肠保留手术。对结果的更多了解将使患者和他们的医生在考虑他们可用的手术选择时能够更充分地了解情况，也将使临床和自助干预的发展以及当前护理算法的潜在质量改进成为可能。

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.