NCT01721304

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 5, 2012

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

3.3 years

First QC Date

October 25, 2012

Last Update Submit

April 21, 2015

Conditions

Abnormal Uterine Bleeding

Keywords

decision makingabnormal uterine bleedingadaptive conjoint analysissatisfactionregret

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Adaptive Conjoint Analysis

EXPERIMENTAL

Computerized survey to elicit preferences

Other: Adaptive Conjoint Analysis

Usual care

NO INTERVENTION

Patients are counseled by their physician as usual

Interventions

Adaptive Conjoint AnalysisOTHER

Computerized survey to elicit patient preferences

Adaptive Conjoint Analysis

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Southern Pines Women's Health Center

Southern Pines, North Carolina, 28388, United States

Location

Related Publications (1)

  • 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.

    PMID: 25074354RESULT

Related Links

MeSH Terms

Conditions

MetrorrhagiaPersonal Satisfaction

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Lisa M Hess, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine and Public Health

Study Record Dates

First Submitted

October 25, 2012

First Posted

November 5, 2012

Study Start

May 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations

US(2)