800 Participants Needed

Decision Aid for Breast Cancer

(CONSYDER Trial)

Recruiting at 3 trial locations
SR
DD
Overseen ByDarima Dorzhieva
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Weill Medical College of Cornell University
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on decision-making for surgery rather than medication changes.

Is the treatment generally safe for humans?

The research mentions that selective estrogen receptor modulators and aromatase inhibitors have been shown to be safe in reducing breast cancer risk in women. Additionally, patient-reported outcomes from a trial involving tamoxifen and anastrozole indicate that side effects like joint pain and hot flashes are common, but these treatments are generally considered safe.12345

How does this treatment differ from other breast cancer treatments?

This treatment is unique because it involves a decision aid, which is a tool designed to help patients make informed choices about their breast cancer treatment options by improving communication with healthcare professionals. Unlike standard treatments that focus solely on medical interventions, this approach emphasizes patient involvement and personalized decision-making.678910

What is the purpose of 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.

Research Team

RG

Rachel Greenup, MD, MPH

Principal Investigator

Yale University

SR

Shoshana Rosenberg, ScD, MPH

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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.

Inclusion Criteria

I am a woman aged between 18 and 44.
I have been newly diagnosed with early-stage breast cancer.

Exclusion Criteria

My breast cancer has come back after initial treatment.
I was diagnosed with Stage 4 breast cancer from the start.
I have cancer in both of my breasts.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in Period

Participants receive usual care and are not sent CONSYDER during this period

6 months

Intervention

Participants use the CONSYDER decision aid tool to assist in surgical decision-making

6 months

Follow-up

Participants are monitored for outcomes such as decisional regret and anxiety

6 months

Treatment Details

Interventions

  • CONSYDER
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials
1,103
Recruited
1,157,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Findings from Research

In a study involving 604 breast cancer patients undergoing chemotherapy, self-reported treatment-related side effects (TSEs) showed significantly longer durations compared to doctor-reported durations, highlighting the importance of patient perspectives in assessing side effects.
The findings suggest that doctors often underestimate the incidence and duration of TSEs, indicating that incorporating patient-reported outcomes into clinical practice could provide a more accurate understanding of the total burden of side effects.
Self-evaluation of duration of adjuvant chemotherapy side effects in breast cancer patients: A prospective study.Galizia, D., Milani, A., Geuna, E., et al.[2021]
In a study of 139 breast cancer patients undergoing chemotherapy, using a mobile app for symptom tracking improved the stabilization of daily functional activity when patients reviewed their data with a physician, compared to those who used the app unsupervised.
Patients using the app reported more adverse events than those using traditional questionnaires, indicating that the app enhances awareness and reporting of chemotherapy side effects, particularly when used in a supervised setting.
A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial.Egbring, M., Far, E., Roos, M., et al.[2022]
Selective estrogen receptor modulators and aromatase inhibitors have been proven effective and safe in significantly reducing the risk of invasive breast cancer in women at increased risk, based on multiple randomized clinical trials.
Professional and governmental agencies recommend offering these drug interventions to at-risk women, as they can substantially lower breast cancer morbidity.
Breast cancer risk reduction: Notable achievements and remaining challenges.Vogel, VG.[2020]

References

Self-evaluation of duration of adjuvant chemotherapy side effects in breast cancer patients: A prospective study. [2021]
A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial. [2022]
Breast cancer risk reduction: Notable achievements and remaining challenges. [2020]
Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial. [2023]
Traditional Korean medicine treatment for tamoxifen associated adverse events of breast cancer patient: A CARE - Compliant case report. [2021]
A decision aid to assist in adjuvant therapy choices for breast cancer. [2013]
Evaluate the effectiveness of breast cancer decision aids: A systematic review and meta-analysis of randomize clinical trails. [2021]
Development and testing of a decision aid for women considering delayed breast reconstruction. [2019]
The experience of using decisional support aids by patients with breast cancer. [2016]
Decision Aids for Decision Making about Locally Advance Breast Cancer: A Systematic Review. [2023]
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