Development and Pilot Test of an Elective Bilateral Salpingo-Oophorectomy (BSO) Decision Support Guide (BSO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01369654|
Recruitment Status : Completed
First Posted : June 9, 2011
Last Update Posted : June 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Surgical Procedure, Unspecified||Behavioral: Computerized decision aid with 1 type of value clarification||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development and Pilot Test of an Elective Bilateral Salpingo-Oophorectomy (BSO) Decision Support Guide|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||December 2014|
|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
- Satisfaction with Intervention [ Time Frame: 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)
- BSO Decisional conflict, regret, anxiety [ Time Frame: 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01369654
|United States, California|
|San Francisco, California, United States, 94118|
|Principal Investigator:||Miriam Kuppermann, PhD, MPH||University of California, San Francisco|