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CONSYDER decision aid for Breast Cancer (CONSYDER Trial)

N/A

Recruiting

Led By Shoshana Rosenberg, ScD, MPH

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female aged 18-44

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post-surgery

Awards & highlights

CONSYDER Trial Summary

This trial aims to improve the decision-making process for young women with breast cancer by using a web-based tool called CONSYDER. Participants will complete surveys before and after surgery, and some may be interviewed

Who is the study for?

This trial is for young women who have recently been diagnosed with breast cancer and are facing surgical decisions. They should be willing to complete surveys around the time of their surgery consultation, after any pre-surgery chemotherapy, and six months post-surgery. Some may also participate in an interview or have their consultation recorded.Check my eligibility

What is being tested?

The study is testing a web-based tool called CONSYDER designed to help young breast cancer patients understand their condition better and make informed surgical choices. It aims to facilitate communication between patients and surgeons.See study design

What are the potential side effects?

Since this trial involves a decision aid rather than medication or invasive procedures, traditional physical side effects are not applicable. However, participants might experience emotional or psychological impacts from engaging with the information and decision-making process.

CONSYDER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged between 18 and 44.

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I have been newly diagnosed with early-stage breast cancer.

CONSYDER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Use of CONSYDER pre-consult

Secondary outcome measures

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

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

Fidelity of implementation of CONSYDER via patient portal email

+7 more

CONSYDER Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CONSYDER decision aidExperimental Treatment1 Intervention

Web-based breast cancer surgery decision aid

Group II: Usual careActive Control1 Intervention

Prior to institutional crossover, participants receive care as per usual for 6 months ("run-in" period) and are not sent CONSYDER.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,055 Previous Clinical Trials

1,315,495 Total Patients Enrolled

30 Trials studying Breast Cancer

27,182 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,925,641 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,050 Total Patients Enrolled

50 Trials studying Breast Cancer

110,785 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May I inquire about the criteria for potential participation in this medical study?

"To be eligible for participation, individuals must have a diagnosis of breast carcinoma and fall within the age bracket of 18 to 44 years. The trial aims to recruit a total of 800 participants."

Answered by AI

At how many different venues can this clinical trial be accessed?

"The clinical trial is conducted at Dana-Farber Cancer Institute in Boston, Massachusetts, Weill Cornell Medicine in New york City, and Duke Cancer Institute in Durham, North carolina. Additionally, it is being carried out at four more sites."

Answered by AI

Are individuals currently able to apply and participate in this ongoing research study?

"The information on clinicaltrials.gov states that this particular medical trial is not currently in the recruitment phase. It was initially listed on February 1, 2024, and its most recent update was on February 15, 2024. Despite this specific trial being closed for enrollment, there are a noteworthy total of 2367 other active trials actively seeking participants at present."

Answered by AI

What are the principal goals that this medical study aims to achieve?

"The primary aim of this investigation, to be assessed approximately before surgery, is to evaluate pre-surgical decisional conflict using the Decisional Conflict Scale (DCS). Secondary objectives involve assessing decisional regret with the Decision Regret Scale (DRS), which consists of 5 items ranked from 1 (strongly agree) to 5 (strongly disagree) and scored between 0-100 through a specific calculation method. Additionally, secondary goals include examining the rate of contralateral prophylactic mastectomy uptake among participants and evaluating how well CONSYDER is implemented via patient portal email by determining the proportion of eligible patients receiving such"

Answered by AI