Health TrialsbyHealthPanel

Optimizing Surgical Decisions in Young Adults With Breast Cancer

ConditionsBreast Cancer Stage 0Breast Cancer Stage IBreast Cancer Stage IIBreast Cancer Stage III
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-44
SponsorWeill Medical College of Cornell University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female aged 18-44

New diagnosis of Stage 0, 1, 2, or 3 unilateral breast cancer

English or Spanish speaking

Disqualifiers

Diagnosis of de novo Stage 4 breast cancer

Recurrent early-stage breast cancer

Bilateral breast cancer

Trial design

Design model

Crossover

Treatments tested in this trial

  • CONSYDER decision aid

    Other intervention

    Web-based breast cancer surgery decision aid

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Usual careNo intervention 0 interventions
Group B: CONSYDER decision aidOther 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
pre-surgery
2

Use of CONSYDER pre-consult

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

Time frame
pre-surgery

Secondary outcomes

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.

Time frame
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).

Time frame
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.

Time frame
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.

Time frame
pre-surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weill Medical College of Cornell University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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