Abnormal Uterine BleedingNCT01721304
Decisionmaking for Abnormal Uterine Bleeding (AUB)
A study testing Adaptive Conjoint Analysis in people with Abnormal Uterine Bleeding, run by Indiana University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abnormal Uterine Bleeding
- What is being tested?
- Adaptive Conjoint Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2009to Aug 2012
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University
Indianapolis, Indiana, 46202
Southern Pines Women's Health Center
Southern Pines, North Carolina, 28388
About this study
Official title: Decision Making Among Treatment Alternatives 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.
Read the 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.
- Conditions
- Abnormal Uterine Bleeding
- Being tested
- Adaptive Conjoint Analysis
- Keywords
- decision making, abnormal uterine bleeding, adaptive conjoint analysis, satisfaction, regret
- Medical subject headings
- Metrorrhagia, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Conjoint AnalysisOther
Computerized survey to elicit patient preferences
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Conjoint Analysis | Experimental | Computerized survey to elicit preferences Receives: Other: Adaptive Conjoint Analysis |
| Usual care | No intervention | Patients are counseled by their physician as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 weeks
Differences in decision regret between treatment groups
Decision regret is measured by the Decision Regret Scale
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2012 (estimated)
- Study startMay 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abnormal Uterine BleedingStudies of the same condition, open and under way.
- 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
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Hess, Indiana University
- Investigators
- Lisa M Hess, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721304
- Sponsor's protocol ID
- 1009001853 (0904-66B)
- Status last verified
- Apr 2015
- First submitted
- 25 Oct 2012
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hess LM, Litwiller A, Byron J, Stutsman J, Kasper K, Learman LA. Preference elicitation tool for abnormal uterine bleeding treatment: a randomized controlled trial. Patient. 2015 Apr;8(2):217-27. doi: 10.1007/s40271-014-0078-8.
PubMed 25074354
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Making Among Treatment Alternatives for Abnormal Uterine Bleeding (AUB)
- ClinicalTrials.gov ID
- NCT01721304
- Acronym / sponsor ID
- 1009001853 (0904-66B)
- Conditions
- Abnormal Uterine Bleeding
- Keywords
- decision making, abnormal uterine bleeding, adaptive conjoint analysis, satisfaction, regret
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 5 Nov 2012 (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 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptive Conjoint Analysis | Experimental | Other: Adaptive Conjoint AnalysisComputerized survey to elicit preferences |
| Usual care | No intervention | –Patients are counseled by their physician as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Adaptive Conjoint AnalysisComputerized survey to elicit patient preferences | Other | Adaptive Conjoint Analysis |
Primary outcome
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
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 22 Apr 2015.
- Results publication: PubMed 25074354Hess LM, Litwiller A, Byron J, Stutsman J, Kasper K, Learman LA. Preference elicitation tool for abnormal uterine bleeding treatment: a randomized controlled trial. Patient. 2015 Apr;8(2):217-27. doi: 10.1007/s40271-014-0078-8.
- Preference elicitation tool for abnormal uterine bleeding treatment: a randomized controlled trial.Link provided by the sponsor.
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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.
Lisa M Hess, PhD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Conjoint Analysis in people with Abnormal Uterine Bleeding, run by Indiana University at 2 sites 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 8 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 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Differences in patient-reported satisfaction between treatment groups (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01721304, which also lists 1 linked publication.
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 22 Apr 2015.