Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach

Breast Cancer Clinical Trial

Official title:

Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03346161
• Other study ID #: 201701045
• Status: Completed
• Phase: Phase 1
• Start date: January 9, 2018
• Est. completion date: October 24, 2018

Study information

• Verified date: July 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 24, 2018
• Est. primary completion date: October 24, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction"
-Booklet from the American Society of Plastic Surgeons about how to choose a breast reconstruction surgeon, what to expect during surgery, what is breast reconstruction, risks of breast reconstruction, recovery, costs, and questions to ask surgeon about breast reconstruction
• Decision tool
-Interactive web based tool. Provides detail about breast reconstruction, asks participant questions about health and medications to personalize risks for breast reconstruction outcome. The tool also goes into pros/cons of breast reconstruction, talks about differences between types of reconstruction, helps people weigh when to have reconstruction (immediate vs. delayed), shows participants representative photos of breast reconstruction outcomes, and assesses patients' knowledge and preferences
• Usual Care Group - Outcome Measures
Section 1 Knowledge (primary outcome) - set of multiple choice questions about breast reconstruction, implants, flap surgeries, and side effects Section 2 Decisional Conflict Scale - 4 questions with yes/no answers dealing with participant's certainty about surgery (it total score less than 4, indicates higher decisional conflict) Section 3 Patient Activation Measures: 3 yes/no questions about participant's knowledge and trust of healthcare provider, sources of info about breast reconstruction, and different options available Section 4 Breast Reconstruction Decision Quality Instrument: 18 multiple choice questions about thought and processes that went into deciding about breast reconstruction Section 5 BREAST-Q: 3 questions about the breast reconstruction consultation appoint answers range from 0=no effort to 9=every effort.
• Decision Group - Outcome Measures
Section 1 Knowledge and Values Clarification Questions - set of multiple choice questions about the participants feelings on breast reconstruction, implants, flap surgeries, and side effects Section 2 Decisional Conflict SURE measure - 4 questions with yes/no answers dealing with participant's conflicts on surgery (if total score less than 4, indicates higher clinical significant decisional conflict) Section 3 Patient Activation Measures: 3 yes/no questions about participant's knowledge and trust of healthcare provider, sources of info about breast reconstruction, and different options available Section 4 Breast Reconstruction Decision Quality Instrument: 18 multiple choice questions about thought and processes that went into deciding about breast reconstruction (for those who have a clinical visit) Section 5 BREAST-Q: 3 questions about the breast reconstruction consultation appointment answers range from 0=no effort to 9=every effort (for those who have a clinical visit).
• Demographic and Background Questions
Asks 15 questions Age, education, ethnicity, race, combined household income, zip code, disease stage, (3) questions about health insurance, (4) questions about participant's ability to work with numbers, heath literacy, health insurance status, and (1) question on if participant spoke to another provider about breast reconstruction decision

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Correct on the Knowledge Measure (Objective Knowledge Score)	To determine whether the CDT increases knowledge about their choice, the investigators will compare objective knowledge scores between participants using the CDT and those who received usual care	Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Primary	Decisional Conflict (SURE Measure)	To determine whether the CDT reduces uncertainty about choice. Participants are asked to report how sure they feel about their choice, if they have enough information to understand the choice, if they are clear about the risks and benefits, and if they have enough support to make a choice. Results are compared between the BREASTChoice and Enhanced Usual Care groups.; Higher SURE values indicate certainty in choice; Scores range from 0-4	Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Primary	Decision Process (Decision Quality Index Subscale)	The total points are summed and then divided by the total number of items to result in scores from 0-100%, with higher scores indicating a more shared decision making process; Assess the extent to which patients were meaningfully involved in decision-making with their clinicians	Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Secondary	Quality of Life as Measured by the BREAST-Q Questionnaire	Assessed 4 subscales: satisfaction with breasts, psychosocial well-being, physical well-being, and sexual well-being; Score from 0 (worst) to 100 (best). Higher scores reflect a better outcome.	Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Secondary	Gold Standard Shared Decision Making as Measured by the Top collaboRATE Score	Top collaboRATE score = the percentage of patients from whom there was 'gold standard' shared decision making as assessed by the collaboRATE measure; The top score is coded as '1', if the response to all three collaboRATE items was less than 9. Then the investigators calculated the percentage of all encounters that were coded as '1' indicating gold standard shared decision making.	Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Secondary	Patient Activation (PAM) as Measured by the Number of Participants Who Agreed With Each Statement	-3 questions consisting of the following: I am confident I can tell my healthcare provider concerns that I have about breast reconstruction even when he or she does not ask (confidence in healthcare provider); I am confident I can find trustworthy sources of information about my breast reconstruction decision (confidence in trustworthy sources); I know the different options available for breast reconstruction (knowledge on breast reconstruction options)	Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Secondary	Receipt of Reconstruction	Assessed if participants received reconstruction	Through follow-up (approximately 6 months)
Secondary	Type of Reconstruction	Assessed what type of reconstruction participants received	Through completion of follow-up (approximately 6 months)
Secondary	Timing of Reconstruction	Assessed timing of reconstruction; Immediate is defined as reconstruction at the time of mastectomy; Delayed is defined as reconstruction any time after the mastectomy and performed as a separate surgery	Through completion of follow-up (approximately 6 months)
Secondary	Time Spent on Tool	How long participants spent on the BREASTChoice tool	Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Secondary	Consult Time	Assessed the time between when the plastic/reconstructive surgeon entered and exited the consult room (not including time spent with a resident, nurse, or other clinical staff)	Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Secondary	Usability as Measured by the Computer System Usability Questionnaire (CSUQ)	Assessed ease of usability of the BREASTChoice tool; Scale is from 1 (strongly disagree) to 7 (strongly agree)	Through completion of breast consultation appointment (total participant time approximately 30 minutes)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine