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Decisionmaking for Abnormal Uterine Bleeding (AUB)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01721304
Enrollment
380
Registered
2012-11-05
Start date
2009-05-31
Completion date
2012-08-31
Last updated
2015-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormal Uterine Bleeding

Keywords

decision making, abnormal uterine bleeding, adaptive conjoint analysis, satisfaction, regret

Brief summary

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

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.

Interventions

OTHERAdaptive Conjoint Analysis

Computerized survey to elicit patient preferences

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Differences in patient-reported satisfaction between treatment groups6 weeksSatisfaction with care as measured by the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-Patient Scale (FACT-TS-PS)
Differences in decision regret between treatment groups6 weeksDecision regret is measured by the Decision Regret Scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026