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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-09

Study Completion Date

2018-10-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Arm 1: BREASTChoice (Decision Tool)

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.

Group Type EXPERIMENTAL

Decision tool

Intervention Type 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

Decision Group - Outcome Measures

Intervention Type 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).

Demographic and Background Questions

Intervention Type 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 2: Enhanced Usual Care (Surgical Care Booklet)

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

Usual Care Group - Outcome Measures

Intervention Type 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.

Demographic and Background Questions

Intervention Type 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

Interventions

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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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type OTHER

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).

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No