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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01369654
First received: June 6, 2011
Last updated: May 3, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Surgical Procedure, Unspecified
 Behavioral: Computerized decision aid with 1 type of value clarification

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Development and Pilot Test of an Elective Bilateral Salpingo-Oophorectomy (BSO) Decision Support Guide

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Hysterectomy
U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Satisfaction with Intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • BSO Decisional conflict, regret, anxiety [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    In the 2nd follow up telephone interview we will ask how helpful was the BSO Decision Support Guide, and if they have any conflicts or regrets with the decisions made.


Enrollment: 63
Study Start Date: May 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Computerized decision aid Behavioral: Computerized decision aid with 1 type of value clarification
Women will be instructed to view a computerized BSO decision support guide.
Other Name: Computerized decision aid with 2 types

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369654

Locations
United States, California
UCSF
San Francisco, California, United States, 94118
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Investigators
Principal Investigator: Miriam Kuppermann, PhD, MPH University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01369654     History of Changes
Other Study ID Numbers: 10-03107
Study First Received: June 6, 2011
Last Updated: May 3, 2013
Health Authority: United States: Federal Government

Keywords provided by University of California, San Francisco:
hysterectomy with Bilateral Salpingo Oophorectomy
Oophorectomy
Gynecologic condition

ClinicalTrials.gov processed this record on May 21, 2013