Breast CancerNCT07335354
A Study of a Decision Tool for People Considering Breast Reconstruction Surgery
A study testing RECONJOINT in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
Trial summary
The purpose of this study is to find out whether it is practical (feasible) to do a larger study looking at the effectiveness of the Breast Reconstruction Decision Aid Tool (RECONJOINT) for breast reconstruction surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- RECONJOINT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 9 sitesUnited States
- Study dates
- 5 Jan 2026to 5 Jan 2029
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Participant Inclusion Criteria
Focus Group Participants
- A diagnosed genetic predisposition to breast cancer or a diagnosis of ductal carcinoma in situ or any invasive cancer confirmed through review of the medical record
- ≥18 years old
- Considering post-mastectomy breast reconstruction
RCT Participants (Patients)
- A diagnosed genetic predisposition to breast cancer or a diagnosis of ductal carcinoma in situ or any invasive cancer confirmed through review of the medical record
- ≥18 years old
- Considering post-mastectomy breast reconstruction
- Have an appointment scheduled for consultation with a plastic surgery provider
RCT Participants (Physicians)
- Provides breast reconstruction care ≥ 50% of the time. This is defined as over half of the surgeon's cases in the preceding calendar year being related to breast reconstruction surgery.
Participant Exclusion Criteria
Focus Group Participants
- Not considering post-mastectomy breast reconstruction
- Non-English proficiency
RCT Participants (Patients)
- Not considering postmastectomy breast reconstruction
- Recurrent or metastatic breast cancer
- Male sex
- Non-English proficiency
RCT Participants (Physicians)
- Does not provide breast reconstruction care at least 50% of the time
- Non-English proficiency
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Evan Matros, MD, 646-608-8044
- Recruiting
Memorial Sloan Kettering Commack
Commack, New York, 11725
Evan Matros, MD, 646-608-8044
- Not yet recruiting
Duke Cancer Institute (Data collection only)
Durham, North Carolina, 27710
Brett Phillips, 888-275-3853
- Recruiting
Duke Cancer Institute (Data collection only)
Durham, North Carolina, 27710
Brett Phillips, 888-275-3853
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Evan Matros, MD, 646-608-8044
- Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Evan Matros, MD, 646-608-8044
- Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Evan Matros, MD, 646-608-8044
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Evan Matros, MD, 646-608-8044
- Recruiting
Memorial Sloan Kettering Nassau
Rockville Centre, New York, 11553
Evan Matros, MD, 646-608-8044
About this study
Official title: Breast Reconstruction Decision Aid (RECONJOINT)
The purpose of this study is to find out whether it is practical (feasible) to do a larger study looking at the effectiveness of the Breast Reconstruction Decision Aid Tool (RECONJOINT) for breast reconstruction surgery.
- Conditions
- Breast Cancer
- Being tested
- RECONJOINT
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RECONJOINTOther
RECONJOINT is a Breast Reconstruction Decision Aid
| Study group | Role | What they receive |
|---|---|---|
| Focus Group Participants | No intervention | Participants will receive usual care |
| RECONJOINT/RCT Participants (Patients) | Experimental | Participants in the RECONJOINT intervention arm will receive the decision aid in addition to enhanced usual care Receives: Other: RECONJOINT |
| RCT Participants (Physicians) | Experimental | Participating surgeons will be randomized to Enhanced Usual Care or Intervention with a 1:1 ratio Receives: Other: RECONJOINT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility determined by participant accrual
Determine the feasibility of a hybrid effectiveness-implementation study that investigates the effectiveness and implementation potential of a decision aid to improve shared decision-making in breast reconstruction.
Measured: <60 days after initial reconstructive surgery consult and before pt's breast reconstruction surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start5 Jan 2026
- Primary completion5 Jan 2029 (estimated)
- Study completion5 Jan 2029 (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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evan Matros, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335354
- Sponsor's protocol ID
- 25-079
- Status last verified
- Jul 2026
- First submitted
- 5 Jan 2026
- Last updated
- 9 Jul 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 following one year after publication and for up to 36 months later. 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 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Reconstruction Decision Aid (RECONJOINT)
- ClinicalTrials.gov ID
- NCT07335354
- Acronym / sponsor ID
- 25-079
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 131 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 5 Jan 2029 (estimated)
- Study completion
- 5 Jan 2029 (estimated)
- First posted
- 13 Jan 2026 (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 it is practical (feasible) to do a larger study looking at the effectiveness of the Breast Reconstruction Decision Aid Tool (RECONJOINT) for breast reconstruction surgery.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Focus Group Participants | No intervention | –Participants will receive usual care |
| RECONJOINT/RCT Participants (Patients) | Experimental | Other: RECONJOINTParticipants in the RECONJOINT intervention arm will receive the decision aid in addition to enhanced usual care |
| RCT Participants (Physicians) | Experimental | Other: RECONJOINTParticipating surgeons will be randomized to Enhanced Usual Care or Intervention with a 1:1 ratio |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- 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 |
|---|---|---|
| RECONJOINTRECONJOINT is a Breast Reconstruction Decision Aid | Other | RCT Participants (Physicians), RECONJOINT/RCT Participants (Patients) |
Primary outcome
Feasibility determined by participant accrual
Time frame: <60 days after initial reconstructive surgery consult and before pt's breast reconstruction surgery
Determine the feasibility of a hybrid effectiveness-implementation study that investigates the effectiveness and implementation potential of a decision aid to improve shared decision-making in breast reconstruction.
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 9 Jul 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 following one year after publication and for up to 36 months later. 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.
Evan Matros, MD principal investigator
Memorial Sloan Kettering Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RECONJOINT in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 9 sites 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: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Contact Evan Matros, MD (646-608-8044, matrose@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility determined by participant accrual (time frame: <60 days after initial reconstructive surgery consult and before pt's breast reconstruction surgery). 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 9 Jul 2026.