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

NCT03346161 | Completed Phase 1 Results

• 1 other identifier: 201701045
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (9)

• Quality of Life as Measured by the BREAST-Q Questionnaire

  Through completion of breast consultation appointment (total participant time approximately 30 minutes)

• Gold Standard Shared Decision Making as Measured by the Top collaboRATE Score

  Through completion of breast consultation appointment (total participant time approximately 30 minutes)

• Patient Activation (PAM) as Measured by the Number of Participants Who Agreed With Each Statement

  Through completion of breast consultation appointment (total participant time approximately 30 minutes)

• Receipt of Reconstruction

  Through follow-up (approximately 6 months)

• Type of Reconstruction

  Through completion of follow-up (approximately 6 months)

Study Arms (2)

Arm 1: BREASTChoice (Decision Tool)

EXPERIMENTAL

Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.

Other: Decision tool; Other: Decision Group - Outcome Measures; Other: Demographic and Background Questions

Arm 2: Enhanced Usual Care (Surgical Care Booklet)

ACTIVE COMPARATOR

Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet "Breast Reconstruction." They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.

Other: Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction"; Other: Usual Care Group - Outcome Measures; Other: Demographic and Background Questions

Interventions

Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction" OTHER

-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

Arm 2: Enhanced Usual Care (Surgical Care Booklet)

Decision tool OTHER

-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

Arm 1: BREASTChoice (Decision Tool)

Usual Care Group - Outcome Measures OTHER

* 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.

Arm 2: Enhanced Usual Care (Surgical Care Booklet)

Decision Group - Outcome Measures OTHER

* 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).

Arm 1: BREASTChoice (Decision Tool)

Demographic and Background Questions OTHER

* 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

Arm 1: BREASTChoice (Decision Tool); Arm 2: Enhanced Usual Care (Surgical Care Booklet)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Demography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Results Point of Contact

• Title: Mary C. Politi, Ph.D.
• Organization: Washington University School of Medicine

mpoliti@wustl.edu

314-747-1967

Study Officials

• Terence M Myckatyn, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Mary C Politi, Ph.D., MPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 17, 2017
• Study Start: January 9, 2018
• Primary Completion: October 24, 2018
• Study Completion: October 24, 2018
• Last Updated: September 6, 2019
• Results First Posted: September 6, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)