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NCT Number: NCT06275126

Optimizing Surgical Decisions in Young Adults With Breast Cancer

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.

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Key information

Conditions

Breast Cancer Stage 0 Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale Cancer Center, New Haven, Connecticut, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

CONSYDER decision aid

Other

Web-based breast cancer surgery decision aid

Primary outcomes

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

    Time frame: pre-surgery

    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.

  2. Use of CONSYDER pre-consult

    Time frame: pre-surgery

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

Secondary outcomes

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

    Time frame: pre-surgery

    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.

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

    Time frame: pre-surgery

    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).

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

    Time frame: pre-surgery and 6 months post-surgery

    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.

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

    Time frame: pre-surgery

    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.

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

    Time frame: 6 months post-surgery

    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.

  6. Receipt of contralateral prophylactic mastectomy

    Time frame: 6 months post-surgery

    Proportion of patients who undergo contralateral prophylactic mastectomy

  7. Fidelity of implementation of CONSYDER via patient portal email

    Time frame: pre-surgical consult

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

  8. Use of CONSYDER post-consult

    Time frame: up to 6 months post-surgical consult

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

  9. Frequency of CONSYDER use pre-consult

    Time frame: pre consult

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

  10. Frequency of CONSYDER use post-consult

    Time frame: up to 6 months post-surgical consult

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

Study contacts

Contact information is provided by the study sponsor or research team.

Darima Dorzhieva

CONTACT

[email protected]

646-962-8666

Shoshana Rosenberg, ScD, MPH

CONTACT

[email protected]

646-962-8041

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Acronym: CONSYDER

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 23, 2024
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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