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临床试验/NCT01126840
NCT01126840已完成不适用

Cancer Survivorship in Lynch Syndrome: Impact on Patients and Families

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 303 人开始时间: 2010年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
303
试验地点
1
主要终点
Compare Predictors of Health-Related Quality of Life (QOL) among Colorectal Cancer (CRC) Survivors who have Lynch Syndrome (LS) with patients who have Sporadic CRC

研究概览

简要总结

Objectives:

Specific Aims:

  1. Researchers will evaluate and compare predictors of health-related quality of life (QOL) among colorectal cancer (CRC) survivors who have Lynch syndrome (LS) with those patients who have sporadic CRC using both quantitative and qualitative methodology.

a. In both CRC groups, researchers will evaluate cancer preventive and health behaviors, including lifestyle factors and screening, psychosocial factors, including mood, family functioning, coping style, anxiety, depression, and social resources, and health care system factors, including interactions with health care providers and service utilization. 2. Researchers will compare the experience of first-degree relatives (FDRs) of patients who have LS with that of FDRs of patients who have sporadic CRC using both quantitative and qualitative methodology.

a. Researchers will evaluate all of the domains listed above, as well as anticipatory grief, assessment of caregiving responsibilities, and fear of cancer in FDRs of patients with LS-related and sporadic CRC. 3. Researchers will examine CRC patients from both groups and their FDRs using dyadic analyses in order to evaluate the similarities and differences in their survivorship experience. 4. Researchers will evaluate the preventive and health behavior of patients who are non-conclusive for Lynch syndrome and their family members. They will examine their screening behavior and will explore how the interaction between the patients and their relatives affects the relatives' screening behavior. They also will examine how these non conclusive LS patients and their family members perceive their risk for LS-related cancers.

详细描述

Data will be collected primarily using a mailed self-administered questionnaire. A subset of the participants who complete the mailed questionnaire will be recontacted and invited to participate in an in-depth, semi-structured telephone interview.

Qualitative Mailed Questionnaires:

Participants will complete a questionnaire that contains questions about your experiences living with colorectal cancer. The questionnaire should take 45-60 minutes to complete.

Up to 200 colorectal cancer survivors and up to 200 close relatives of colorectal cancer survivors will take part in this portion of the study.

Telephone Interviews:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Colorectal cancer (CRC) patients with Lynch-syndrome related CRC: Diagnosis of CRC
  • Colorectal cancer (CRC) patients with sporadic CRC: Diagnosis of CRC
  • All First-degree relatives (FDRs): Siblings or adult children of recruited CRC patients
  • All Participants: 18 years of age or older
  • All Participants: Able to read and speak English
  • All Participants: Able to be contacted by mail.
  • All Second and Third relatives (SDRs and TDRs): Grandparents, grandchildren, aunts, uncles, nieces, nephews, and first-degree cousins of recruited CRC patients
  • IPs with a LS MMR mutation who were seen at MDACC for genetic counseling and testing during 2011-2014.

排除标准

  • CRC patients with sporadic CRC: Personal or family history of Lynch syndrome, familial adenomatous polyposis, inflammatory bowel disease or those who have a FDR with CRC

结局指标

主要结局

Compare Predictors of Health-Related Quality of Life (QOL) among Colorectal Cancer (CRC) Survivors who have Lynch Syndrome (LS) with patients who have Sporadic CRC

时间窗: 1 Year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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