Breast CancerPhase 1NCT03346161
Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach
A Phase 1 study testing Decision tool, Decision Group - Outcome Measures and Demographic and Background Questions in people with Breast Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Decision tool, Decision Group - Outcome Measures and Demographic and Background Questions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2018to 24 Oct 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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
- Being tested
- Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction", Decision tool, Usual Care Group - Outcome Measures, Decision Group - Outcome Measures, Demographic and Background Questions
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Decision toolOther
-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
Usual Care Group - Outcome MeasuresOther
- 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.
Decision Group - Outcome MeasuresOther
- 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 QuestionsOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction"; Other: Usual Care Group - Outcome Measures; Other: Demographic and Background Questions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
- 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.
Measured: 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.
Measured: 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)
Measured: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Receipt of Reconstruction
Assessed if participants received reconstruction
Measured: Through follow-up (approximately 6 months)
Type of Reconstruction
Assessed what type of reconstruction participants received
Measured: 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
Measured: Through completion of follow-up (approximately 6 months)
Time Spent on Tool
How long participants spent on the BREASTChoice tool
Measured: 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)
Measured: 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)
Measured: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start9 Jan 2018
- Primary completion24 Oct 2018
- Study completion24 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terence M Myckatyn, M.D., Principal investigator, Washington University School of MedicineMary C Politi, Ph.D., MPH, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346161
- Sponsor's protocol ID
- 201701045
- Status last verified
- Jul 2019
- First submitted
- 1 Nov 2017
- Last updated
- 6 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach
- ClinicalTrials.gov ID
- NCT03346161
- Acronym / sponsor ID
- 201701045
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 24 Oct 2018 (actual)
- Study completion
- 24 Oct 2018 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Posted 6 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: BREASTChoice (Decision Tool) | Experimental | Other: Decision tool, Other: Decision Group - Outcome Measures, Other: Demographic and Background QuestionsInvestigators 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. |
| Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Active comparator | Other: Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction", Other: Usual Care Group - Outcome Measures, Other: Demographic and Background QuestionsInvestigators 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Arm 2: Enhanced Usual Care (Surgical Care Booklet) |
| 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 | Other | Arm 1: BREASTChoice (Decision Tool) |
| 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. | Other | Arm 2: Enhanced Usual Care (Surgical Care Booklet) |
| 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). | Other | Arm 1: BREASTChoice (Decision Tool) |
| 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 | Other | Arm 1: BREASTChoice (Decision Tool), Arm 2: Enhanced Usual Care (Surgical Care Booklet) |
Primary outcome
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
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
9 secondary outcomes
Quality of Life as Measured by the BREAST-Q Questionnaire
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
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
Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Receipt of Reconstruction
Time frame: Through follow-up (approximately 6 months)
Type of Reconstruction
Time frame: Through completion of follow-up (approximately 6 months)
Timing of Reconstruction
Time frame: Through completion of follow-up (approximately 6 months)
Time Spent on Tool
Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Consult Time
Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Usability as Measured by the Computer System Usability Questionnaire (CSUQ)
Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terence M Myckatyn, M.D. principal investigator
Washington University School of Medicine
Mary C Politi, Ph.D., MPH principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Decision tool, Decision Group - Outcome Measures and Demographic and Background Questions in people with Breast Cancer, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Correct on the Knowledge Measure (Objective Knowledge Score) (time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019; AzTrials last refreshed its copy on 30 Oct 2026.