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Decision Aid for Breast Cancer

N/A

Recruiting

Led By Katherine D Crew

Research Sponsored by SWOG Cancer Research Network

Eligibility Criteria Checklist

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

Must have

Patients must be women at least 35 and no more than 74 years of age at registration, since the Breast Cancer Surveillance Consortium (BCSC) risk calculator is valid only for this age range

Patients must be able to read and write in English or Spanish since study questionnaires and educational materials are only available in English and Spanish

Must not have

Patients must not have a history of invasive breast cancer or ductal carcinoma in situ

Patients must not be currently taking hormone replacement therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing web-based tools to help patients with early stage breast cancer make decisions about treatment. The goal is to learn how best to implement these tools in clinical practice.

Who is the study for?

This trial is for English or Spanish-speaking women aged 35-74 with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS), who have internet access and can give informed consent. It's not for those pregnant, lactating, with a history of invasive breast cancer or ductal carcinoma in situ, prior/current use of certain breast cancer drugs, hormone therapy, bilateral mastectomies/breast implants, or premenopausal thromboembolism.

What is being tested?

The MiCHOICE study tests web-based decision support tools to help patients and healthcare providers make informed choices about breast cancer chemoprevention. The goal is to understand how these tools affect decision-making processes and their integration into clinical practice.

What are the potential side effects?

Since the interventions include educational materials and interviews rather than medical treatments, there are no direct physical side effects associated with this trial. However, participants may experience psychological impacts from discussing sensitive health information.

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 35 and 74.

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I can read and write in English or Spanish.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never had invasive breast cancer or ductal carcinoma in situ.

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I am not currently on hormone replacement therapy.

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I have not had both breasts removed or have breast implants.

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I have never used drugs for hormone therapy like SERMs or AIs.

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I am premenopausal and have no history of blood clots.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Chemoprevention informed choice

Secondary study objectives

Accuracy of risk perception

Actual breast cancer risk score

Breast cancer worry

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group II (educational materials, decision support, interview)Experimental Treatment4 Interventions

Patients receive standard educational materials about breast cancer risk and chemoprevention in RealRisks via the patient portal or website. Patients receive patient-centered decision support within the patient portal via an action plan summarizing their breast cancer risk profile, their risks and benefits of SERMs and AIs, and personal preferences for chemoprevention. Health care providers receive decision support and action plans based on their patients' interactions with RealRisks via the BNAV provider-centered support tool within the EHR. A sample of patients participate in an audio-recorded interview via telephone or video conference over 45-60 minutes at 12 months after registration. A sample of health care providers participate in 3 audio-recorded interviews via telephone or video conference over 45-60 minutes each at baseline, within 12-36 months after study activation, and within 12 months after study closure to accrual.

Group II: Group I (educational materials)Active Control2 Interventions

Patients receive standard educational materials about breast cancer risk and chemoprevention in RealRisks via the patient portal or website.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cancer Educational Materials

2019

N/A

~2360

0 / 7Eligibility criteria met