Decisionmaking for Abnormal Uterine Bleeding (AUB)

Study Overview
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Brief Summary
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The purpose of this study is to determine if using a computer survey about preferences for treatment of abnormal uterine bleeding (AUB) is useful and if it will improve patient satisfaction with clinical care and decision making. This study is a two-part study. The first pilot tests the computerized tool to ensure it is understood by patients, then the second part is a randomized study (computerized tool versus usual care) to see if improvements are made in satisfaction and if there are reductions in decision regret.

Detailed Description
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The purpose of this study is to determine if using a computer survey about preferences for treatment of abnormal uterine bleeding (AUB) is useful and if it will improve patient satisfaction with clinical care and decision making. This study was designed to develop and test the use of ACA as part of routine clinical care for women diagnosed with AUB. After pilot testing, the ACA survey is administered in this study where patients are assigned to receive the ACA or to usual care.

Official Title
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Decision Making Among Treatment Alternatives for Abnormal Uterine Bleeding (AUB)

Conditions
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Abnormal Uterine Bleeding

Intervention / Treatment
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* Other: Adaptive Conjoint Analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have received a diagnosis of dysfunctional or abnormal uterine bleeding (AUB) that is recommended for treatment Have not yet selected or initiated treatment for current AUB diagnosis Be at least 18 years of age. Be possible candidates for either medical or surgical therapy Able to provide informed consent for treatment options for oneself Exclusion Criteria: Are currently being treated for cancer Any cancer diagnosis within the past 2 years (other than non-melanoma skin cancer) AUB due to serious pelvic pathology, medications, pregnancy or systemic disease that limits their range of treatment options Are not recommended for surgical intervention Are not recommended for medical intervention Are under 18 years of age Have not received a diagnosis of AUB Are currently being treated for AUB

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adaptive Conjoint Analysis<br>Computerized survey to elicit preferences | Other: Adaptive Conjoint Analysis<br>* Computerized survey to elicit patient preferences<br>|
| No Intervention: Usual care<br>Patients are counseled by their physician as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in patient-reported satisfaction between treatment groups | Satisfaction with care as measured by the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-Patient Scale (FACT-TS-PS) | 6 weeks | 
| Differences in decision regret between treatment groups | Decision regret is measured by the Decision Regret Scale | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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decision making, abnormal uterine bleeding, adaptive conjoint analysis, satisfaction, regret