Breast CancerNCT05025020
Use of an Interactive 3D Tool During Consultation for Breast Reconstruction Surgery
A study testing interactive 3D tool, BREAST-Q Reconstruction Module and DQI in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to find out whether using an interactive 3D tool during a standard surgical consultation can lead to greater patient satisfaction with the information provided about breast reconstruction options than the standard consultation alone. 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?
- interactive 3D tool, BREAST-Q Reconstruction Module and DQI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2021to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- ≥18 years old
- Presenting at MSK for initial breast reconstruction consultation
- Planning to undergo mastectomy at time of consultation
- English spoken as primary language
- Able to provide informed consent without a legally authorized representative
Who cannot join
- Prior breast reconstruction
- Prior breast reconstruction consultation with a plastic surgeon
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
About this study
Official title: Incorporating Three-Dimensional Visualization in Breast Reconstruction Consultation
The purpose of this study is to find out whether using an interactive 3D tool during a standard surgical consultation can lead to greater patient satisfaction with the information provided about breast reconstruction options than the standard consultation alone. The study researchers will also assess whether women whose surgical consultation includes the use of the 3D tool are more satisfied with their breasts and with the decisions they made about their reconstruction procedure.
- Conditions
- Breast Cancer
- Being tested
- interactive 3D tool, BREAST-Q Reconstruction Module, DQI, Ottawa Decision Regret Scale
- Keywords
- Reconstruction Surgery, Interactive 3D Tool, Consultation, 21-318
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interactive 3D toolOther
The study tool displays 3-dimensional step-by-step animations of autologous and implant-based breast reconstruction procedures.
BREAST-Q Reconstruction ModuleOther
The BREAST-Q Reconstruction Module1-3 has 6 domains that cover various aspects of patient satisfaction and quality of life. BREAST-Q is part of our standard of care for patients treated for breast cancer and referred for reconstruction.
DQIOther
The DQI has 3 domains that cover decision-specific questions about what it is like for a patient to make decisions about reconstruction after breast cancer treatment.
Ottawa Decision Regret ScaleOther
The validated Decision Regret Scale measures distress or remorse after a health care decision by the use of 5 items to indicate the extent to which the respondent agrees or disagrees with the statements in the regret scale.
| Study group | Role | What they receive |
|---|---|---|
| Standard consultation with interactive 3D visualization | Experimental | Participants in this group will use the interactive 3D tool in addition to receiving the standard surgical consultation before their breast reconstruction procedure. Receives: Other: interactive 3D tool; Other: BREAST-Q Reconstruction Module; Other: DQI; Other: Ottawa Decision Regret Scale |
| Standard consultation | Active comparator | Participants in this group will receive a standard surgical consultation before their breast reconstruction procedure. Receives: Other: BREAST-Q Reconstruction Module; Other: DQI; Other: Ottawa Decision Regret Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
BREAST-Q Satisfaction
scores at 4 weeks (T2) Scores for each domain of the BREAST-Q range from 0 to 100, implying a continuum of increasing satisfaction or better quality of life.
Measured: 4 weeks
Secondary outcomes (1)
BREAST-Q Satisfaction
The outcome will be the score (continuous variable ranging from 0 to 100 for linear regression or ordinal categories, ranging from 1 to 4 for ordinallogistic regression, where 1 represents lowest satisfaction and 4 represents highest satisfaction), and the primary predictor of interest will be type of consultation provided.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start23 Aug 2021
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carrie Stern, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025020
- Sponsor's protocol ID
- 21-318
- Status last verified
- Sep 2026
- First submitted
- 23 Aug 2021
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating Three-Dimensional Visualization in Breast Reconstruction Consultation
- ClinicalTrials.gov ID
- NCT05025020
- Acronym / sponsor ID
- 21-318
- Conditions
- Breast Cancer
- Keywords
- Reconstruction Surgery, Interactive 3D Tool, Consultation, 21-318
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out whether using an interactive 3D tool during a standard surgical consultation can lead to greater patient satisfaction with the information provided about breast reconstruction options than the standard consultation alone. The study researchers will also assess whether women whose surgical consultation includes the use of the 3D tool are more satisfied with their breasts and with the decisions they made about their reconstruction procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard consultation with interactive 3D visualization | Experimental | Other: interactive 3D tool, Other: BREAST-Q Reconstruction Module, Other: DQI, Other: Ottawa Decision Regret ScaleParticipants in this group will use the interactive 3D tool in addition to receiving the standard surgical consultation before their breast reconstruction procedure. |
| Standard consultation | Active comparator | Other: BREAST-Q Reconstruction Module, Other: DQI, Other: Ottawa Decision Regret ScaleParticipants in this group will receive a standard surgical consultation before their breast reconstruction procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years old
- Presenting at MSK for initial breast reconstruction consultation
- Planning to undergo mastectomy at time of consultation
- English spoken as primary language
- Able to provide informed consent without a legally authorized representative
Key exclusion criteria (2 listed)
- Prior breast reconstruction
- Prior breast reconstruction consultation with a plastic surgeon
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 |
|---|---|---|
| interactive 3D toolThe study tool displays 3-dimensional step-by-step animations of autologous and implant-based breast reconstruction procedures. | Other | Standard consultation with interactive 3D visualization |
| BREAST-Q Reconstruction ModuleThe BREAST-Q Reconstruction Module1-3 has 6 domains that cover various aspects of patient satisfaction and quality of life. BREAST-Q is part of our standard of care for patients treated for breast cancer and referred for reconstruction. | Other | Standard consultation, Standard consultation with interactive 3D visualization |
| DQIThe DQI has 3 domains that cover decision-specific questions about what it is like for a patient to make decisions about reconstruction after breast cancer treatment. | Other | Standard consultation, Standard consultation with interactive 3D visualization |
| Ottawa Decision Regret ScaleThe validated Decision Regret Scale measures distress or remorse after a health care decision by the use of 5 items to indicate the extent to which the respondent agrees or disagrees with the statements in the regret scale. | Other | Standard consultation, Standard consultation with interactive 3D visualization |
Primary outcome
BREAST-Q Satisfaction
Time frame: 4 weeks
scores at 4 weeks (T2) Scores for each domain of the BREAST-Q range from 0 to 100, implying a continuum of increasing satisfaction or better quality of life.
1 secondary outcome
BREAST-Q Satisfaction
Time frame: 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Carrie Stern, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interactive 3D tool, BREAST-Q Reconstruction Module and DQI in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center 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?
The sponsor lists 5 inclusion and 2 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
BREAST-Q Satisfaction (time frame: 4 weeks). 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 3 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.