A Phase 1 interventional study of Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction" and Decision tool in Breast Cancer, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-06.
Sponsored by Washington University School of Medicine · Phase 1, Interventional, and Health services research
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.
12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 120 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Washington University School of Medicine is the lead sponsor of 1,795 studies on the registry; 270 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 216 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
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
-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
-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
* 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.
* 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).
* 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
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)
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)
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)
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)
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)
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)
Receipt of Reconstruction
Assessed if participants received reconstruction
Time frame: Through follow-up (approximately 6 months)
Type of Reconstruction
Assessed what type of reconstruction participants received
Time frame: Through completion of follow-up (approximately 6 months)
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)
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)
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)
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)
The study was opened to participant enrollment on 01/12/2018 and closed to participant enrollment on 10/24/2018.
| Milestone | Arm 1: BREASTChoice (Decision Tool) | Arm 2: Enhanced Usual Care (Surgical Care Booklet) |
|---|---|---|
| Started | 60 | 60 |
| Completed | 60 | 60 |
| Not completed | 0 | 0 |
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
| percentage of answers correct | Arm 1: BREASTChoice (Decision Tool) | Arm 2: Enhanced Usual Care (Surgical Care Booklet) |
|---|---|---|
| Percent Correct on the Knowledge Measure (Objective Knowledge Score) | 84.6 ± 14.2 | 59.7 ± 18.0 |
* 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
| score on a scale | Arm 1: BREASTChoice (Decision Tool) | Arm 2: Enhanced Usual Care (Surgical Care Booklet) |
|---|---|---|
| Decisional Conflict (SURE Measure) | 2.9 ± 1.2 | 2.5 ± 1.4 |
* 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
| score on a scale | Arm 1: BREASTChoice (Decision Tool) | Arm 2: Enhanced Usual Care (Surgical Care Booklet) |
|---|---|---|
| Decision Process (Decision Quality Index Subscale) | 65.1 ± 21.5 | 58.2 ± 20.7 |
* 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.
| score on a scale | Arm 1: BREASTChoice (Decision Tool) | Arm 2: Enhanced Usual Care (Surgical Care Booklet) |
|---|---|---|
| Satisfaction with breasts | 58.5 ± 24.8 | 57.3 ± 23.7 |
| Psychosocial well-being | 64.6 ± 19.9 | 71.2 ± 17.6 |
| Physical well-being | 79.5 ± 18.1 | 82.7 ± 16.5 |
| Sexual well-being | 56.3 ± 19.4 | 61.2 ± 19.2 |
* 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.
| Participants | Arm 1: BREASTChoice (Decision Tool) | Arm 2: Enhanced Usual Care (Surgical Care Booklet) |
|---|---|---|
| Gold Standard Shared Decision Making as Measured by the Top collaboRATE Score | 33 | 37 |
-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)
| Participants | Arm 1: BREASTChoice (Decision Tool) | Arm 2: Enhanced Usual Care (Surgical Care Booklet) |
|---|---|---|
| Confidence in healthcare provider | 55 | 59 |
| Confidence in trustworthy sources | 57 | 58 |
| Knowledge on breast reconstruction options | 56 | 50 |
Assessed if participants received reconstruction
| Participants | Arm 1: BREASTChoice (Decision Tool) | Arm 2: Enhanced Usual Care (Surgical Care Booklet) |
|---|---|---|
| Yes | 48 | 47 |
| No/Not yet started | 11 | 8 |
| Not applicable (breast-conserving surgery) | 1 | 3 |
Assessed what type of reconstruction participants received
| Participants | Arm 1: BREASTChoice (Decision Tool) | Arm 2: Enhanced Usual Care (Surgical Care Booklet) |
|---|---|---|
| Implant | 23 | 27 |
| Flap | 10 | 8 |
| Unknown | 15 | 12 |
* 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
| Participants | Arm 1: BREASTChoice (Decision Tool) | Arm 2: Enhanced Usual Care (Surgical Care Booklet) |
|---|---|---|
| Immediate | 45 | 47 |
| Delayed | 3 | 0 |
How long participants spent on the BREASTChoice tool
| minutes | Arm 1: BREASTChoice (Decision Tool) | Arm 2: Enhanced Usual Care (Surgical Care Booklet) |
|---|---|---|
| Time Spent on Tool | 26.7 (9.9 to 130.2) | — |
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)
| minutes | Arm 1: BREASTChoice (Decision Tool) | Arm 2: Enhanced Usual Care (Surgical Care Booklet) |
|---|---|---|
| Consult Time | 29.9 (10 to 58) | 30 (9 to 65) |
* Assessed ease of usability of the BREASTChoice tool * Scale is from 1 (strongly disagree) to 7 (strongly agree)
| score on a scale | Arm 1: BREASTChoice (Decision Tool) | Arm 2: Enhanced Usual Care (Surgical Care Booklet) |
|---|---|---|
| Usability as Measured by the Computer System Usability Questionnaire (CSUQ) | 6.3 (4.8 to 7.0) | — |
Collected over Adverse events were collected from the start of study enrollment until completion of patient follow-up (approximately 15 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1: BREASTChoice (Decision Tool) | 1/60 (1.7%) | 0/60 (0%) | 0/60 (0%) |
| Arm 2: Enhanced Usual Care (Surgical Care Booklet) | 1/60 (1.7%) | 0/60 (0%) | 0/60 (0%) |
| Age, Continuous(years) | Arm 1: BREASTChoice (Decision Tool) | Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Total |
|---|---|---|---|
| Mean | 52.3 (31 to 77) | 49.1 (25 to 74) | 50.7 (25 to 77) |
| Sex: Female, Male(Participants) | Arm 1: BREASTChoice (Decision Tool) | Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Total |
|---|---|---|---|
| Female | 60 | 60 | 120 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Arm 1: BREASTChoice (Decision Tool) | Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 56 | 58 | 114 |
| Unknown or Not Reported | 3 | 2 | 5 |
| Race (NIH/OMB)(Participants) | Arm 1: BREASTChoice (Decision Tool) | Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 3 | 6 | 9 |
| White | 49 | 52 | 101 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 3 | 1 | 4 |
| Region of Enrollment(participants) | Arm 1: BREASTChoice (Decision Tool) | Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Total |
|---|---|---|---|
| United States | 60 | 60 | 120 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Jan 2018 to primary completion in Oct 2018, 9 months.
Results were first posted in Sep 2019, 10 months after primary completion.
Of 339 non-industry phase 1 interventional studies under Breast Neoplasms, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 77. This study's 9 months is below that.
Counting every sponsor, half of 645 studies reached it within 45 months; a quarter within 25 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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