Surgical Procedure, UnspecifiedBSONCT01369654
Development and Pilot Test of an Elective Bilateral Salpingo-Oophorectomy (BSO) Decision Support Guide
A study testing Computerized decision aid with 1 type of value clarification in people with Surgical Procedure, Unspecified, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- Computerized decision aid with 1 type of value clarification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- Computerized decision aid with 1 type of value clarification
- Keywords
- hysterectomy with Bilateral Salpingo Oophorectomy, Oophorectomy, Gynecologic condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized decision aid with 1 type of value clarificationBehavioural
Also called Computerized decision aid with 2 types
Women will be instructed to view a computerized BSO decision support guide.
| Study group | Role | What they receive |
|---|---|---|
| Computerized decision aid | Experimental | Not described Receives: Behavioral: Computerized decision aid with 1 type of value clarification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with Intervention
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)
Measured: 6 months
Secondary outcomes (1)
BSO Decisional conflict, regret, anxiety
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Miriam Kuppermann, PhD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369654
- Sponsor's protocol ID
- 10-03107
- Acronym
- BSO
- Status last verified
- Jun 2015
- First submitted
- 6 Jun 2011
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Test of an Elective Bilateral Salpingo-Oophorectomy (BSO) Decision Support Guide
- ClinicalTrials.gov ID
- NCT01369654
- Acronym / sponsor ID
- BSO / 10-03107
- Conditions
- Surgical Procedure, Unspecified
- Keywords
- hysterectomy with Bilateral Salpingo Oophorectomy, Oophorectomy, Gynecologic condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computerized decision aid | Experimental | Behavioral: Computerized decision aid with 1 type of value clarification |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized decision aid with 1 type of value clarificationAlso: Computerized decision aid with 2 typesWomen will be instructed to view a computerized BSO decision support guide. | Behavioural | Computerized decision aid |
Primary outcome
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)
1 secondary outcome
BSO Decisional conflict, regret, anxiety
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miriam Kuppermann, PhD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized decision aid with 1 type of value clarification in people with Surgical Procedure, Unspecified, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with Intervention (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2015; AzTrials last refreshed its copy on 6 Nov 2026.