Grant Number:	2R01CA106912-04A1 Interpret this number
Primary Investigator:	Krouse, Robert
Organization:	University Of Arizona
Project Title:	Hr-Qol in Colorectal Cancer Survivors with Stomas
Fiscal Year:	2009

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.





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