Clinical trial NCT03346161: Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach
Official title: Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Although clinical decision tools (CDTs) exist for a variety of treatments, CDTs designed to support personalized breast reconstruction decisions, particularly about type and timing of reconstruction, are lacking. The objective of this proposal is to develop and pilot test a clinical decision tool that provides personalized risk information and reflects patients' preferences and clinical needs.


Eligibility criteria: * Newly diagnosed or recurrent breast cancer
* Considering a referral or already referred to a plastic surgeon by their surgical oncologist for possible reconstruction
* Considering or completing a mastectomy.
* Does not have known distant metastatic disease (stage IV disease) at the time of recruitment
* Female.
* English-speaking.
* At least 18 years of age.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Primary outcomes:
measure: Percent Correct on the Knowledge Measure (Objective Knowledge Score)
timeFrame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
measure: Decisional Conflict (SURE Measure)
timeFrame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
measure: Decision Process (Decision Quality Index Subscale)
timeFrame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Secondary outcomes:
measure: Quality of Life as Measured by the BREAST-Q Questionnaire
timeFrame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
measure: Gold Standard Shared Decision Making as Measured by the Top collaboRATE Score
timeFrame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
measure: Patient Activation (PAM) as Measured by the Number of Participants Who Agreed With Each Statement
timeFrame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
measure: Receipt of Reconstruction
timeFrame: Through follow-up (approximately 6 months)
measure: Type of Reconstruction
timeFrame: Through completion of follow-up (approximately 6 months)
measure: Timing of Reconstruction
timeFrame: Through completion of follow-up (approximately 6 months)
measure: Time Spent on Tool
timeFrame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
measure: Consult Time
timeFrame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
measure: Usability as Measured by the Computer System Usability Questionnaire (CSUQ)
timeFrame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Terence M Myckatyn, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Mary C Politi, Ph.D., MPH
role: PRINCIPAL_INVESTIGATOR
References: