NCT00201929已完成3 期
Development and Evaluation of Different Versions of the Decision Board for Early Breast Cancer
Ontario Clinical Oncology Group (OCOG)18 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2002年4月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 18
- 主要终点
- Patient comprehension
研究概览
简要总结
To enhance information transfer and decision making for women with breast cancer.
详细描述
Our specific objectives are: (i) to develop computer and paper based versions of the Decision Boards for (a) chemotherapy for early stage breast cancer (chemotherapy versus no treatment), (b) mastectomy versus lumpectomy plus radiation and (ii) to compare the relative effectiveness of the computer and paper based versions with the standard Decision Board for patients with early breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Chemotherapy Group:
- •Histologically documented invasive carcinoma of the breast treated with modified radical mastectomy or lumpectomy
- •Axillary node dissection
- •Chemotherapy alone or in addition to tamoxifen as an appropriate treatment option
- •Surgery Group:
- •Newly diagnosed carcinoma of the breast diagnosed either by cytology or pathological examination, OR if no biopsy, a strong clinical suspicion of malignancy
- •Clinical stage I or II disease
- •Candidate for breast conserving surgery
排除标准
- •Chemotherapy Group:
- •Candidate for CEF chemotherapy
- •Clinical evidence of metastatic disease
- •Serious comorbidity that would preclude receiving chemotherapy treatment
- •Unable to speak or read English fluently (including visual impairment)
- •Mentally incompetent including any psychiatric or addictive disorders that would preclude shared decision-making
- •Surgery Group:
- •Previous surgery for breast cancer
- •Previous breast irradiation
- •Clinical suspicion of bilateral breast cancer
- •Serious comorbidity that would preclude definitive surgery
- •Unable to speak or read English fluently (including visual impairment)
- •Mentally incompetent including any psychiatric or addictive disorder that would preclude shared decision making
结局指标
主要结局
Patient comprehension
Patient satisfaction with information transfer
次要结局
- Patient satisfaction with decision making
- Physician satisfaction with information transfer
- Physician satisfaction with decision making
- Time required for administration of the instrument
- Patient preference for decision making
研究者
研究点 (18)
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