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临床试验/NCT01369654
NCT01369654已完成不适用

Development and Pilot Test of an Elective Bilateral Salpingo-Oophorectomy (BSO) Decision Support Guide

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2011年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
1
主要终点
Satisfaction with Intervention

研究概览

简要总结

The investigators propose to conduct formative research to gain an understanding of patients' needs and desires regarding elective Bilateral Salpingo-Oophorectomy (BSO) decision making, and to develop and pilot test a BSO Decision Support Guide, in preparation for a randomized, controlled trial of the effect of this decision aid on decision quality and use of BSO. The proposed study will consist of 3 phases. In phase 1, the investigators plan to conduct focus groups among women who have had a hysterectomy with or without bilateral salpingo-oophorectomy (BSO) to gain an understanding of what they understood about BSO and its possible outcomes at the time of their hysterectomy and what they would have liked to have known, the extent and manner in which they were included in decision making regarding BSO, and how they feel about the decision now. The investigators also will collect qualitative data from women who are scheduled for hysterectomy and currently facing the decision whether or not to undergo elective BSO. In phase 2, the investigators plan to create a BSO Decision Support Guide using information obtained from the literature, from our formative research, and the experience of providers who have counseled women about this choice. In phase 3, the investigators plan to pilot test the BSO Decision Support Guide among women scheduled to undergo hysterectomy for benign conditions to assess its usefulness and usability for patients and their providers and to prepare for a randomized study of its impact on decision quality and use of BSO. 62 women who are scheduled to undergo hysterectomy for a non-cancerous uterine condition will participate in the pilot study. These women will participate in a baseline interview, during which they will be provided access to the BSO Decision Support Guide, and 2 follow up telephone interviews (one as they are making their final BSO decision and a second after they have undergone and recovered from their hysterectomy (with or without BSO). Data will be used to generate the final version of the Decision Support Guide, to finalize evaluation measures for future studies of the effectiveness of the guide, and to determine effect sizes for the outcomes of knowledge, BSO use, decision satisfaction and decisional conflict.

详细描述

Specific Aim 1) Conduct formative research to assess how sociodemographically diverse women who will be undergoing hysterectomy for non-cancerous conditions view elective BSO and to assess their information needs and desires regarding shared decision making in this context.

Specific Aim 2) Create a BSO Decision Support Guide using information obtained from the literature, from our formative research, and the experience of providers who have counseled women about this choice.

Specific Aim 3) Pilot test the BSO Decision Support Guide among women scheduled to undergo hysterectomy for benign conditions to assess its usefulness and usability for patients and their providers and to prepare for a randomized study of its impact on decision quality and use of BSO.

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

年龄范围
40 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Premenopausal defined as having at least one menses in the 3 months prior to surgery;
  • age >40 years;
  • Plans to undergo an elective hysterectomy for symptomatic fibroids, abnormal bleeding, pelvic pain, or pelvic organ prolapse;
  • Plans to undergo hysterectomy via any route (laparoscopic, laparotomy, or vaginal;
  • speaks English

排除标准

  • having personal or family history of breast and/or ovarian cancer or a known breast cancer gene (BRCA) mutation;
  • Known or suspected adnexal mass by exam or radiologic imaging;
  • Gynecologist recommends BSO for treatment of pelvic pain and/or endometriosis;
  • Diagnosis of coronary heart disease (CHD) or osteoporosis;
  • Cannot speak English;
  • Less than 40 years of age.

研究组 & 干预措施

Computerized decision aid

Experimental

干预措施: Computerized decision aid with 1 type of value clarification (Behavioral)

结局指标

主要结局

Satisfaction with Intervention

时间窗: 6 months

After study participants participate in a baseline interview, during which they will be provided access to the BSO Decision Support guide, they will receive 2 follow up telephone interviews (one as they are making their final BSO decision and a second after they have undergone and recovered from their hysterectomy (with or without BSO)

次要结局

  • BSO Decisional conflict, regret, anxiety(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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