CompletedNot Applicable

Decisionmaking for Abnormal Uterine Bleeding (AUB)

United States380 participantsStarted 2009-05

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Differences in patient-reported satisfaction between treatment groups

Timeframe: 6 weeks

Differences in decision regret between treatment groups

Timeframe: 6 weeks

Trial details

NCT IDNCT01721304

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-08

View on ClinicalTrials.gov More Abnormal Uterine Bleeding trials