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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am a woman aged between 35 and 74.
Select...
I can read and write in English or Spanish.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Chemoprevention informed choice
Secondary outcome measures
Accuracy of risk perception
Actual breast cancer risk score
Breast cancer worry
+7 moreTrial 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.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,695 Previous Clinical Trials
40,929,372 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
264,205 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
260,846 Total Patients Enrolled
Media Library
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many facilities in the state are undertaking this experiment?
"VCU Massey Cancer Center at Stony Point in Richmond, Virginia; Carle Physician Group-Effingham in Effingham, Illinois; and Cancer Care Centre of O'Fallon in O'Fallon Minnesota are some of the 49 clinical trial sites actively enrolling patients."
Answered by AI
What is the current count of participants in this clinical trial?
"This study requires 415 eligible patients to participate. Those looking for participation opportunities can refer to VCU Massey Cancer Center at Stony Point in Richmond, Virginia and Carle Physician Group-Effingham in Effingham, Illinois as potential sites."
Answered by AI
Does this research endeavor still have vacancies for participants?
"Correct. Clinicaltrials.gov indicates that this medical trial, first made available on September 1st 2020, is currently enrolling patients. 415 participants need to be recruited from 49 different locations."
Answered by AI
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