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临床试验/ISRCTN18709765
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

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

发起方
Cardiff University (UK)

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