Breast Cancer
Conditions
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.
Interventions
OTHERUsual 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
OTHERDecision 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
OTHERUsual 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.
OTHERDecision 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).
OTHERDemographic 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
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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 * Female. * English-speaking. * At least 18 years of age. * Able to understand and willing to sign an IRB-approved written informed consent document.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Correct on the Knowledge Measure (Objective Knowledge Score) | 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) | 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 |
| Decision Process (Decision Quality Index Subscale) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life as Measured by the BREAST-Q Questionnaire | Through completion of breast consultation appointment (total participant time approximately 30 minutes) | * 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. |
| Gold Standard Shared Decision Making as Measured by the Top collaboRATE Score | Through completion of breast consultation appointment (total participant time approximately 30 minutes) | * 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. |
| 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) | -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) |
| Receipt of Reconstruction | Through follow-up (approximately 6 months) | Assessed if participants received reconstruction |
| Type of Reconstruction | Through completion of follow-up (approximately 6 months) | Assessed what type of reconstruction participants received |
| Timing of Reconstruction | Through completion of follow-up (approximately 6 months) | * 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 |
| Time Spent on Tool | Through completion of breast consultation appointment (total participant time approximately 30 minutes) | How long participants spent on the BREASTChoice tool |
| Consult Time | Through completion of breast consultation appointment (total participant time approximately 30 minutes) | 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) |
| Usability as Measured by the Computer System Usability Questionnaire (CSUQ) | Through completion of breast consultation appointment (total participant time approximately 30 minutes) | * Assessed ease of usability of the BREASTChoice tool * Scale is from 1 (strongly disagree) to 7 (strongly agree) |
Countries
United States
Participant flow
Recruitment details
The study was opened to participant enrollment on 01/12/2018 and closed to participant enrollment on 10/24/2018.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| 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. | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | Arm 1: BREASTChoice (Decision Tool) | Total | Arm 2: Enhanced Usual Care (Surgical Care Booklet) |
|---|---|---|---|
| Age, Continuous | 52.3 years | 50.7 years | 49.1 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 114 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 9 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) White | 49 Participants | 101 Participants | 52 Participants |
| Region of Enrollment United States | 60 participants | 120 participants | 60 participants |
| Sex: Female, Male Female | 60 Participants | 120 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 60 | 1 / 60 |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
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
Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: BREASTChoice (Decision Tool) | Decisional Conflict (SURE Measure) | 2.9 score on a scale | Standard Deviation 1.2 |
| Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Decisional Conflict (SURE Measure) | 2.5 score on a scale | Standard Deviation 1.4 |
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
Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: BREASTChoice (Decision Tool) | Decision Process (Decision Quality Index Subscale) | 65.1 score on a scale | Standard Deviation 21.5 |
| Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Decision Process (Decision Quality Index Subscale) | 58.2 score on a scale | Standard Deviation 20.7 |
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
Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: BREASTChoice (Decision Tool) | Percent Correct on the Knowledge Measure (Objective Knowledge Score) | 84.6 percentage of answers correct | Standard Deviation 14.2 |
| Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Percent Correct on the Knowledge Measure (Objective Knowledge Score) | 59.7 percentage of answers correct | Standard Deviation 18 |
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)
Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1: BREASTChoice (Decision Tool) | Consult Time | 29.9 minutes |
| Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Consult Time | 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.
Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Population: 3 participants from Arm 1 were excluded from the outcome measure as their data was missing. 1 participants from Arm 2 was excluded from the outcome measure as her data was missing.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: BREASTChoice (Decision Tool) | Gold Standard Shared Decision Making as Measured by the Top collaboRATE Score | 33 Participants |
| Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Gold Standard Shared Decision Making as Measured by the Top collaboRATE Score | 37 Participants |
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)
Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Population: 3 participants in the BREASTChoice arm did not provide an answer to this question and are not evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: BREASTChoice (Decision Tool) | Patient Activation (PAM) as Measured by the Number of Participants Who Agreed With Each Statement | Confidence in trustworthy sources | 57 Participants |
| Arm 1: BREASTChoice (Decision Tool) | Patient Activation (PAM) as Measured by the Number of Participants Who Agreed With Each Statement | Knowledge on breast reconstruction options | 56 Participants |
| Arm 1: BREASTChoice (Decision Tool) | Patient Activation (PAM) as Measured by the Number of Participants Who Agreed With Each Statement | Confidence in healthcare provider | 55 Participants |
| Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Patient Activation (PAM) as Measured by the Number of Participants Who Agreed With Each Statement | Confidence in trustworthy sources | 58 Participants |
| Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Patient Activation (PAM) as Measured by the Number of Participants Who Agreed With Each Statement | Confidence in healthcare provider | 59 Participants |
| Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Patient Activation (PAM) as Measured by the Number of Participants Who Agreed With Each Statement | Knowledge on breast reconstruction options | 50 Participants |
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.
Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: BREASTChoice (Decision Tool) | Quality of Life as Measured by the BREAST-Q Questionnaire | Sexual well-being | 56.3 score on a scale | Standard Deviation 19.4 |
| Arm 1: BREASTChoice (Decision Tool) | Quality of Life as Measured by the BREAST-Q Questionnaire | Satisfaction with breasts | 58.5 score on a scale | Standard Deviation 24.8 |
| Arm 1: BREASTChoice (Decision Tool) | Quality of Life as Measured by the BREAST-Q Questionnaire | Psychosocial well-being | 64.6 score on a scale | Standard Deviation 19.9 |
| Arm 1: BREASTChoice (Decision Tool) | Quality of Life as Measured by the BREAST-Q Questionnaire | Physical well-being | 79.5 score on a scale | Standard Deviation 18.1 |
| Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Quality of Life as Measured by the BREAST-Q Questionnaire | Physical well-being | 82.7 score on a scale | Standard Deviation 16.5 |
| Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Quality of Life as Measured by the BREAST-Q Questionnaire | Sexual well-being | 61.2 score on a scale | Standard Deviation 19.2 |
| Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Quality of Life as Measured by the BREAST-Q Questionnaire | Psychosocial well-being | 71.2 score on a scale | Standard Deviation 17.6 |
| Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Quality of Life as Measured by the BREAST-Q Questionnaire | Satisfaction with breasts | 57.3 score on a scale | Standard Deviation 23.7 |
Secondary
Receipt of Reconstruction
Assessed if participants received reconstruction
Time frame: Through follow-up (approximately 6 months)
Population: 2 participants in the Enhanced Usual Care arm have not had their reconstruction surgery but are planning to schedule it but it is outside the follow-up window.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: BREASTChoice (Decision Tool) | Receipt of Reconstruction | Yes | 48 Participants |
| Arm 1: BREASTChoice (Decision Tool) | Receipt of Reconstruction | No/Not yet started | 11 Participants |
| Arm 1: BREASTChoice (Decision Tool) | Receipt of Reconstruction | Not applicable (breast-conserving surgery) | 1 Participants |
| Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Receipt of Reconstruction | Yes | 47 Participants |
| Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Receipt of Reconstruction | No/Not yet started | 8 Participants |
| Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Receipt of Reconstruction | Not applicable (breast-conserving surgery) | 3 Participants |
Secondary
Time Spent on Tool
How long participants spent on the BREASTChoice tool
Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Population: -Only patients randomized to BREASTChoice (Decision Tool) are evaluable for this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm 1: BREASTChoice (Decision Tool) | Time Spent on Tool | 26.7 minutes |
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
Time frame: Through completion of follow-up (approximately 6 months)
Population: Only patients who had reconstruction are applicable for this outcome measure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: BREASTChoice (Decision Tool) | Timing of Reconstruction | Immediate | 45 Participants |
| Arm 1: BREASTChoice (Decision Tool) | Timing of Reconstruction | Delayed | 3 Participants |
| Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Timing of Reconstruction | Immediate | 47 Participants |
| Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Timing of Reconstruction | Delayed | 0 Participants |
Secondary
Type of Reconstruction
Assessed what type of reconstruction participants received
Time frame: Through completion of follow-up (approximately 6 months)
Population: Only patients who had reconstruction are applicable for this outcome measure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: BREASTChoice (Decision Tool) | Type of Reconstruction | Implant | 23 Participants |
| Arm 1: BREASTChoice (Decision Tool) | Type of Reconstruction | Flap | 10 Participants |
| Arm 1: BREASTChoice (Decision Tool) | Type of Reconstruction | Unknown | 15 Participants |
| Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Type of Reconstruction | Implant | 27 Participants |
| Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Type of Reconstruction | Flap | 8 Participants |
| Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Type of Reconstruction | Unknown | 12 Participants |
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)
Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Population: -Only patients randomized to BREASTChoice (Decision Tool) are evaluable for this outcome measure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1: BREASTChoice (Decision Tool) | Usability as Measured by the Computer System Usability Questionnaire (CSUQ) | 6.3 score on a scale |