Decisionmaking for Abnormal Uterine Bleeding (AUB)

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.

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Key information

Conditions

Abnormal Uterine Bleeding Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Metrorrhagia Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University, Indianapolis, Indiana, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adaptive Conjoint Analysis

Other

Computerized survey to elicit patient preferences

Primary outcomes

Differences in patient-reported satisfaction between treatment groups

Time frame: 6 weeks

Satisfaction 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 groups

Time frame: 6 weeks

Decision regret is measured by the Decision Regret Scale

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Nov 5, 2012
Registry last updated: Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed