Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Decision Process (Decision Quality Index Subscale)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •English-speaking.
- •At least 18 years of age.
- •Able to understand and willing to sign an IRB-approved written informed consent document.
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Decision tool (Other)
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.
Intervention: Decision Group - Outcome Measures (Other)
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.
Intervention: Demographic and Background Questions (Other)
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.
Intervention: Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction" (Other)
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.
Intervention: Usual Care Group - Outcome Measures (Other)
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.
Intervention: Demographic and Background Questions (Other)
Outcomes
Primary Outcomes
Decision Process (Decision Quality Index Subscale)
Time Frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
* 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
Percent Correct on the Knowledge Measure (Objective Knowledge Score)
Time Frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
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
Decisional Conflict (SURE Measure)
Time Frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
* 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
Secondary Outcomes
- Quality of Life as Measured by the BREAST-Q Questionnaire(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))
- Timing of Reconstruction(Through completion of follow-up (approximately 6 months))
- Consult Time(Through completion of breast consultation appointment (total participant time approximately 30 minutes))
- Usability as Measured by the Computer System Usability Questionnaire (CSUQ)(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))
- Type of Reconstruction(Through completion of follow-up (approximately 6 months))
- Time Spent on Tool(Through completion of breast consultation appointment (total participant time approximately 30 minutes))