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Breast Cancer Stage 0CONSYDERNCT06275126

Optimizing Surgical Decisions in Young Adults With Breast Cancer

A study testing CONSYDER decision aid in people with Breast Cancer Stage 0 and Breast Cancer Stage I, run by Weill Medical College of Cornell University at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this study is to understand and improve the breast surgical decision-making process for young women newly diagnosed with breast cancer. As part of this study, the investigators will evaluate the impact and use a web-based tool called CONSYDER that is designed to provide useful information to young breast… Read more about this study

Who is it for?
Ages 18 to 44 years, women only
What is being tested?
CONSYDER decision aid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
4 sitesUnited States
Study dates
13 Mar 2024to 31 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 to 44 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Female aged 18-44
  • New diagnosis of Stage 0, 1, 2, or 3 unilateral breast cancer
  • English or Spanish speaking

Who cannot join

  • Diagnosis of de novo Stage 4 breast cancer
  • Recurrent early-stage breast cancer
  • Bilateral breast cancer

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shoshana Rosenberg, ScD, MPH contact

646-962-8041

shr4009@med.cornell.edu

Darima Dorzhieva contact

646-962-8666

dad4011@med.cornell.edu

United States4 sites, 4 recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Ann Partridge, MD, MPH, 617-632-3800, ann_partridge@dfci.harvard.edu

    Ann Partridge, MD, MPH

    Recruiting

  • Duke Cancer Institute

    Durham, North Carolina, 27710

    Jennifer Plichta, MD, MS, 9196819156, jennifer.plichta@duke.edu

    Jennifer Plichta, MD, MS

    Recruiting

  • Yale Cancer Center

    New Haven, Connecticut, 06510

    Rachel Greenup, MD, MPH, 203-737-2966, rachel.greenup@yale.edu

    Rachel Greenup, MD, MPH

    Recruiting

  • Weill Cornell Medicine

    New York, New York, 10065

    Shoshana Rosenberg, ScD, MPH, 646-962-8041, shr4009@med.cornell.edu

    Darima Dorzhieva, 646-962-8666, dad4011@med.cornell.edu

    Recruiting

Other trials in United States

About this study

The goal of this study is to understand and improve the breast surgical decision-making process for young women newly diagnosed with breast cancer. As part of this study, the investigators will evaluate the impact and use a web-based tool called CONSYDER that is designed to provide useful information to young breast cancer patients. It is also meant to improve communication between young women and their surgeons with the purpose of helping patients make appropriate surgical decisions.

Participants will complete surveys approximately within 1 week of the surgical consult and approximately 6 months after surgery. Patients who receive neoadjuvant chemotherapy will also be surveyed after the completion of neoadjuvant treatment but prior to surgery. Some patients will be invited for an interview after their surgery as part of the evaluation. A subset of patients/surgeons will also have their surgical consultation audio-recorded.

Read the detailed description

Primary objectives:

  • To test the effectiveness of the CONSYDER decision support tool on reducing decisional conflict prior to breast cancer surgery.
  • To evaluate the implementation of and mechanisms of use for CONSYDER.

Secondary Objectives:

  • To determine the impact of CONSYDER on decision-making preferences, breast cancer knowledge, treatment goals and preferences, anxiety, decisional regret, and self-efficacy in communication.

Exploratory Objectives:

  • To explore whether CONSYDER impacts surgical choice.

OUTLINE: This is a multi-site cluster randomized trial using a stepped wedge design. Approximately 800 women will be recruited at 4 study sites (Weill Cornell Medicine, Yale Cancer Center, Dana-Farber Cancer Institute, Duke Cancer Institute), including network affiliate sites, over an approximate 30-month period. All sites will have a 6-month "run-in" period where patients will not be sent CONSYDER. The 6-month blocks may be extended if recruitment targets are not met. Sites will be randomized to begin delivery of CONSYDER to all newly diagnosed women, age ≤44, with Stage 0-III breast cancer as part of routine clinical care; young women will have access to the website whether or not they consent to research study participation.

Being tested
CONSYDER decision aid
Medical subject headings
Breast Carcinoma In Situ, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CONSYDER decision aidOther

    Web-based breast cancer surgery decision aid

Study groups in NCT06275126
Study groupRoleWhat they receive
Usual careNo interventionPrior to institutional crossover, participants receive care as per usual for 6 months ("run-in" period) and are not sent CONSYDER.
CONSYDER decision aidOtherWeb-based breast cancer surgery decision aid
Receives: Other: CONSYDER decision aid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pre-surgical decisional conflict as measured by the Decisional Conflict Scale (DCS)

    The Decisional Conflict Scale (DCS) includes 5 subscales (uncertainty, informed, values clarity, support, effective decision). Each item is rated on a scale of 0 (strongly agree)-4 (strongly disagree). Scores range from 0-100 with higher scores indicating more decisional conflict.

    Measured: pre-surgery

  2. Use of CONSYDER pre-consult

    Proportion of patients eligible to use CONSYDER who logged in prior to surgical consult

    Measured: pre-surgery

Secondary outcomes (10)

  1. Knowledge as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS -DQI)

    Breast cancer knowledge will be assessed using selected questions from the adapted Breast Cancer Surgery Decision Quality Instrument (BCS -DQI), an instrument designed to evaluate the quality of breast cancer treatment decisions. The number of correct responses across (out of a total of 5 items) will be summed.

    Measured: pre-surgery

  2. Treatment goals and preferences as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS-DQI)

    Treatment goals and preferences have been adapted from the BCS-DQI to include preferences salient to young women. We will ask participants to mark on a scale (not important, 0-extremely important, 10) the importance of several reasons in relation to their surgical decision. Ratings for each item will be summarized (e.g., mean, median, range).

    Measured: pre-surgery

  3. Anxiety, as measured with the 8-item Patient Reported Outcomes Measurement Information System (PROMIS) - Anxiety - Short Form

    Anxiety, as measured with the 8-item PROMIS - Anxiety - Short Form. Response options for each item range from never (1) to always (5). Raw scores range from 5-40 and T-scores range from 37.1-83.1. Higher scores indicate higher levels of anxiety.

    Measured: pre-surgery and 6 months post-surgery

  4. Self-efficacy in communication as measured by the Perceived Efficacy in Patient-Physician Interactions scale (PEPPI).

    Perceived Efficacy in Patient-Physician Interactions scale (PEPPI) has 5 items. Each item is rated on a (0, not confident at all - 10, extremely confident) scale. Scores range from 0-50, with higher scores indicating greater self-efficacy.

    Measured: pre-surgery

  5. Decisional regret as measured by the Decision Regret Scale (DRS)

    The Decision Regret Scale (DRS) includes 5 items. Each item is rated on a scale of 1 (strongly agree)-5 (strongly disagree). Scores range from 0-100 (item scores are converted by subtracting "1" from individual items and multiplying by 25). Higher scores indicate more decisional regret.

    Measured: 6 months post-surgery

  6. Receipt of contralateral prophylactic mastectomy

    Proportion of patients who undergo contralateral prophylactic mastectomy

    Measured: 6 months post-surgery

  7. Fidelity of implementation of CONSYDER via patient portal email

    Proportion of patients eligible to use CONSYDER who were sent an email from patient portal

    Measured: pre-surgical consult

  8. Use of CONSYDER post-consult

    Proportion of patients who logged in to CONSYDER post-surgical consult

    Measured: up to 6 months post-surgical consult

  9. Frequency of CONSYDER use pre-consult

    Count of the number log-ins to CONSYDER pre-consult

    Measured: pre consult

  10. Frequency of CONSYDER use post-consult

    Count of the number log-ins to CONSYDER post-consult

    Measured: up to 6 months post-surgical consult

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2024
  2. Study start13 Mar 2024
  3. Primary completion1 May 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Crossover
Model description
The study is a pragmatic, Type II hybrid effectiveness-implementation, stepped-wedge design that will incorporate a mixed-methods approach to test the efficacy and evaluate the implementation of the CONSYDER intervention
Masking
None (open label)
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06275126
Sponsor's protocol ID
23-08026433
Other IDs
R01CA256877-01A1
Acronym
CONSYDER
Status last verified
Aug 2026
First submitted
6 Feb 2024
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data sets will made available, by request, to outside researchers. A data use agreement may be required with participating institutions to facilitate sharing of any data sets. Data from qualitative interviews, focus groups, audio-recordings, and any data collected from clinicians/providers will not be made available due to concerns about potentially identifying information being shared.

Questions about this trial

What is this clinical trial studying?

A study testing CONSYDER decision aid in people with Breast Cancer Stage 0 and Breast Cancer Stage I, run by Weill Medical College of Cornell University at 4 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?

The sponsor lists 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 Shoshana Rosenberg, ScD, MPH (646-962-8041, shr4009@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pre-surgical decisional conflict as measured by the Decisional Conflict Scale (DCS) (time frame: pre-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06275126.

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 19 Aug 2026.

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