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


N/A
40 Years
55 Years
Open (Enrolling)
Female
Surgical Procedure, Unspecified

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Satisfaction with Intervention

Outcome Description:

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)

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Miriam Kuppermann, PhD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Federal Government

Study ID:

10-03107

NCT ID:

NCT01369654

Start Date:

May 2011

Completion Date:

December 2014

Related Keywords:

  • Surgical Procedure, Unspecified
  • hysterectomy with Bilateral Salpingo Oophorectomy
  • Oophorectomy
  • Gynecologic condition

Name

Location
UCSF San Francisco, California  941430324