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

NCT01369654 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2015-06-04

No results posted yet for this 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 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.

Conditions

  • Surgical Procedure, Unspecified

Interventions

BEHAVIORAL

Computerized decision aid with 1 type of value clarification

Women will be instructed to view a computerized BSO decision support guide.

Sponsors & Collaborators

Principal Investigators

  • Miriam Kuppermann, PhD, MPH · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-09-30
Completion
2014-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01369654 on ClinicalTrials.gov