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临床试验/NCT01366248
NCT01366248已完成不适用

Breast Cancer Integrative Oncology: Prospective Matched Controlled Outcomes Study

Bastyr University6 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
750
试验地点
6
主要终点
Aim 2: Compare health-related quality of life (HRQOL) experienced by a group of breast cancer patients receiving IO care with HRQOL of a group of matched comparison women.

研究概览

简要总结

This NIH-NCCAM funded epidemiologic research is being conducted as an observational prospective case-control study of the use of Complementary and Alternative Medicine (CAM) and Integrated Oncology (IO) and their effects on breast cancer patients in community settings.

Hypothesis: IO services improve patients' quality of life and decrease cancer recurrence rates in breast cancer patients as compared to women with similar disease states and prognoses who do not receive IO care, and may or may not use CAM treatment on their own.

研究设计

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

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Aim 2: Compare health-related quality of life (HRQOL) experienced by a group of breast cancer patients receiving IO care with HRQOL of a group of matched comparison women.

时间窗: 6-60 months post-enrollment

Comparison will be between breast cancer patients living in the same geographic area with similar prognostic characteristics (age, stage of cancer at diagnosis, estrogen receptor/ progesterone receptor (ER/PR) status, race, ethnicity, and marital status) at the time of their initial diagnosis with breast cancer who did not receive IO care. We will identify an average of three (up to four each) matched controls for each eligible IO clinic cancer patient from the Western Washington CSS database and to invite them to enroll in the outcomes study.

Aim 1: Describe treatments received by breast cancer patients receiving physician level practitioner IO care and the cost of IO care.

时间窗: Baseline, 6, 12, 24, 36, 48, and 60 months post study enrollment.

Will also describe how long after diagnosis women with breast cancer seek IO care and differences in IO care prescriptions associated with when, in a woman's course of treatment, she seeks care. This patient cohort will consist of all female patients with breast cancer seeking IO clinic care. Our analyses will describe how long after diagnosis women with breast cancer seek IO care and describe differences in IO care prescriptions associated with when, in a woman's course of treatment, she seeks care.

次要结局

  • Aim 3: Collect pilot data on survival, comorbidities, and abnormal laboratory values.(6-60 months post-enrollment)
  • Aim 5: Compare the HRQOL of women who self-prescribe CAM with those who do not(Baseline and 6, 12, 24, 36, 48 and 60 months post-enrollment)
  • Aim 4: Describe and compare CAM treatments(Baseline, 6, 12, 24, 48, and 60 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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