ISRCTN18709765已完成未知
A decision explorer for women deciding about breast cancer treatments: BresDex trial
Cardiff University (UK)0 个研究点目标入组 148 人开始时间: 2010年4月29日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 148
研究概览
简要总结
2012 results in https://www.ncbi.nlm.nih.gov/pubmed/22541508
研究设计
- 研究类型
- Observational
入排标准
- 性别
- Female
入选标准
- •Patient needs assessment:
- •1. Women diagnosed as having early breast cancer within 3 to 6 months of their 1st therapeutic treatment
- •2. Given an option of either breast conservation surgery or mastectomy
- •Professional needs assessment:
- •Data will be collected from a purposive sample of NHS based individuals recruited to represent a number of multidisciplinary breast teams and their constituent members; breast surgeons, breast care nurses, breast oncologists, opinion leaders with expertise in the surgical, oncological and psycho-oncological perspectives of breast cancer management including a representative of the Association of Breast Surgeons at the British Association of Surgical Oncology (BASO).
- •1. Willingness to be interviewed about this area of clinical practice
- •2. Experience of directly dealing with women facing treatment decisions for early breast cancer
- •Prototype development:
- •1. Women (any age) diagnosed as having early breast cancer (stage 1)
- •2. Given an option of either breast conservation surgery or mastectomy
- •3. Within 3 to 6 months of their first therapeutic treatment
- •External key informants including the health care professionals identified and consented in Step 3 and those nominated by the Study Management Group who agree to provide formative advice will also be consulted during the prototype development. These key informants must show a willingness to participate in the development and evaluation of a prototype of the decision explorer.
- •Evaluation of completed decision explorer:
- •1. Women (any age) diagnosed as having early breast cancer (stage 1 and 2)
- •2. Surgical treatment options
排除标准
- •Patient needs assessment:
- •1. Women beyond 6 months of their initial therapeutic treatment who have chosen to undergo either breast conservation surgery or mastectomy
- •2. Women recently diagnosed with breast cancer who were not given surgical treatment options
- •3. Any conditions or illness that preclude the completion of a semi-structured interview about the issue of breast cancer, i.e. mental illness such as severe anxiety or depression likely to be exacerbated by discussing the diagnosis
- •4. Any conditions precluding the ability to give informed consent to participate in the study
- •Professional needs assessment:
- •1. For the sample of NHS-based multidisciplinary team members, health care professionals who are not permanent specialist members of specialist multidisciplinary breast team
- •2. Individuals not routinely involved in discussing treatment options with patients newly diagnosed with breast cancer
- •Prototype development:
- •1. Women beyond 6 months of their initial therapeutic treatment who have chosen to undergo either breast conservation surgery or mastectomy
- •2. Women recently diagnosed with breast cancer who were not given surgical treatment options
- •3. Any conditions or illness that preclude the completion of a semi-structured interview about the issue of breast cancer, i.e. mental illness such as severe anxiety or depression likely to be exacerbated by discussing the diagnosis
- •4. Any conditions precluding the ability to give informed consent to participate in the study
- •Evaluation of completed decision explorer:
- •1. Women beyond their initial therapeutic surgical treatment who have chosen to undergo either breast conservation surgery or mastectomy
- •2. Women recently diagnosed with breast cancer who were not given surgical treatment options
- •3. Any conditions or illness that preclude the completion of a semi-structured interview about the consideration of treatment choices for early breast cancer, i.e. mental illness such as severe anxiety or depression likely to be exacerbated by discussing the diagnosis
- •4. Conditions precluding the ability to give informed consent to participate in the study
- •5. Health care professionals who are not involved in the care and therefore the recruitment of patients asked to use the decision explorer in this step
研究者
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