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NCT01369654 · ClinicalTrials.gov registry record · NA
Development and Pilot Test of an Elective Bilateral Salpingo-Oophorectomy (BSO) Decision Support Guide
A NA study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 63
- Enrollment target
NCT01369654 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 63 participants.
The verdict
NCT01369654, a NA study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 63 participants
- Enrollment target
Study Summary
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
Interventions
- BEHAVIORAL Computerized decision aid with 1 type of value clarification
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2011-05 |
| Est. Completion | 2014-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01369654
The ClinicalTrials.gov registry entry for NCT01369654 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Computerized decision aid with 1 type of value clarification is the first listed.
NCT01369654 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01369654 about?
NCT01369654 is a clinical study titled "Development and Pilot Test of an Elective Bilateral Salpingo-Oophorectomy (BSO) Decision Support Guide". 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 t...
What is the current status of trial NCT01369654?
This trial is currently completed. It is a NA study. The enrollment target is 63 participants. The study started on 2011-05. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01369654?
The interventions under investigation include: Computerized decision aid with 1 type of value clarification (BEHAVIORAL).
Who is sponsoring clinical trial NCT01369654?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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