An interventional study of Cancer Educational Materials and Decision Aid in Atypical Hyperplasia of the Breast, Lobular Breast Carcinoma In Situ and Pleomorphic Lobular Breast Carcinoma In Situ, sponsored by SWOG Cancer Research Network. Active, not recruiting at 97 sites in 2 countries. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by SWOG Cancer Research Network · Not applicable, Interventional, and Prevention
This trial studies the implementation of web-based decision support tools for patients with atypical hyperplasia or lobular carcinoma in situ and healthcare providers. Decision support tools are designed to improve informed choice about breast cancer chemoprevention. Recognizing barriers and facilitators that can influence the adoption of decision support tools at recruitment centers may help researchers learn how to best implement them into clinical practice.
PRIMARY OBJECTIVE:
I. To compare the frequency of chemoprevention informed choice at 6 months after registration among women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) between the intervention (RealRisks decision aid/breast cancer risk navigation [BNAV] + standard educational materials) and control (standard educational materials alone) arms.
SECONDARY OBJECTIVES:
I. To assess patient chemoprevention knowledge, chemoprevention intention/decision, perceived breast cancer risk and worry, accuracy of breast cancer risk perception, decision conflict and decision regret at baseline, 6 months, and 12 months in the intervention and control arms.
II. To compare patient chemoprevention usage, adherence, and reasons for discontinuation of a selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) annually for up to 5 years between the intervention and control arms.
III. To assess shared decision-making about chemoprevention among patients and healthcare providers after their 6-month clinic visit in the intervention and control arms.
IMPLEMENTATION OBJECTIVE:
I. To assess the implementation of the decision support tools, RealRisks and BNAV, into clinic workflow, and to better understand barriers and facilitators to chemoprevention usage by conducting telephone/video-conference interviews of healthcare providers and high-risk women with AH or LCIS assigned to the active intervention.
OUTLINE: Recruitment centers are randomized to 1 of 2 groups.
GROUP I (CONTROL): Patients receive standard educational materials about breast cancer risk and chemoprevention in RealRisks via the patient portal or website.
GROUP II (INTERVENTION): 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 electronic health record (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.
After completion of study, patients are followed up at 6, 12, 24, 36, 48, and 60 months.
190 studies on the registry are indexed under Breast Carcinoma In Situ; 25 are open to participants now.
This study's enrollment of 412 is above the median of 80 across 144 interventional studies indexed under Breast Carcinoma In Situ.
Browse Breast Carcinoma In Situ studies →SWOG Cancer Research Network is the lead sponsor of 339 studies on the registry; 37 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients must not have prior or current use of selective estrogen receptor modulators (SERMs) or aromatase inhibitors (AIs)
NOTE: The following are approved SERMS and AIs, however, the study is not limited to these.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive standard educational materials about breast cancer risk and chemoprevention in RealRisks via the patient portal or website.
Behavioral: Cancer Educational Materials · Other: Questionnaire Administration
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.
Behavioral: Cancer Educational Materials · Other: Decision Aid · Other: Interview · Other: Questionnaire Administration
Receive educational materials about breast cancer risk and chemoprevention via RealRisk
Given patient-centered decision support via an action plan
Given decision support and action plans based on patient's interactions with RealRisks via the BNAV support tool
Participate in audio-recorded interview via telephone or video conference
Ancillary studies
Chemoprevention informed choice
Will be provided by chemoprevention knowledge scale, a 1-item attitudes scale, and chemoprevention decision and measure at 6 and 12 months on the S1904 Follow-Up Choice form. All enrolled patients who provide outcomes data at the 6-month timepoint will be included in the primary analysis under the intention-to-treat principle. The primary analysis of the intervention effect on informed choice at 6 months will be based on a logistic regression model using a generalized estimating equation approach to account for clustering. Additional supportive analyses will adjust for both patient and clinic level factors. If there are substantial missing data for the components of the primary endpoint, a sensitivity analysis will be conducted imputing a response of no informed decision making for those women with missing information.
Time frame: At 6 months
Perceived breast cancer risk
Will be assessed by absolute estimate ("How do you rate your chance of developing breast cancer?"), comparative risk ("Overall, how do you think your chance of developing breast cancer compares to the average woman your age?"), and numeric risk ("Please place an X on the line below at the point showing what you think your chance is of developing breast cancer in the next five years"). All are assessed on a scale of 0% to 100%, with 0% as "no chance of breast cancer" and 100% as "definitely will get breast cancer."
Time frame: Up to 12 months
Actual breast cancer risk score
A numeric score between the values of 0% and 100%, as determined by the Breast Cancer Surveillance Consortium (BCSC) risk models. The 5-year and 10-year risk estimates are used. The items needed for the BCSC risk models are obtained at baseline from the S1904 Onstudy.
Time frame: Up to 12 months
Accuracy of risk perception
Will be defined as the difference between numeric perceived breast cancer 10-year risk estimate (subjective) and actual 10-year breast cancer risk score, according to the BCSC risk model (objective). Categorized as: accurate if the difference between subjective and objective risk estimates are =\< 10% in either direction; underestimate if \> 10% below objective risk; and overestimate if \> 10% above objective risk.
Time frame: Up to 12 months
Breast cancer worry
Will be measured by two Likert-style items, with responses ranging from "Not at all" (1) to "All of the time" (7). Items are reported and scored separately. Breast cancer worry is assessed on the S1904 Breast Cancer Risk Questionnaire.
Time frame: Up to 12 months
Decision conflict
Will be assessed on the S1904 Breast Cancer Risk Questionnaire. Will be measured by a validated 10-item scale with 3 response categories (Yes/Unsure/No) to assess the level of conflict women feel about their decisions regarding chemoprevention. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict) and will be scored according to the User Manual - Decisional Conflict Scale.
Time frame: Up to 12 months
Decision regret
Will be assessed on the S1904 Decision Questionnaire. Will be measured by a validated 5-item scale composed of 5-point Likert-style items. Scores that range from 0 (no regret) to 100 (high regret). It is scored according to the User Manual - Decision Regret Scale.
Time frame: Up to 12 months
Chemoprevention usage
Will be assessed on the S1904 Follow-Up form and the S1904 Breast Cancer Risk-Reducing Pill Usage form. Among patients who do not have a diagnosis of invasive breast cancer or ductal carcinoma in situ, it will be defined as reporting having started taking or currently taking a selective estrogen receptor modulators (SERM) or aromatase inhibitor (AI) for primary prevention, as assessed by self-report, and taking at least one dose of a SERM or AI for primary prevention, as assessed by the site based on the electronic health record log. Both measures will be reported. Reasons for never starting chemoprevention will be recorded.
Time frame: Up to 5 years
Chemoprevention adherence
Will be assessed using a 3-item scale for patients currently taking a SERM or AI. Responses are given values 1 through 5, with the response corresponding to perfect adherence assigned 1. The three scores are averaged if at least 2 of the 3 items have responses. Non-adherence is defined as an average score of greater than 1. Will be assessed on the S1904 Breast Cancer Risk-Reducing Pill Usage form.
Time frame: Up to 5 years
Reasons for chemoprevention discontinuation
For patients who report discontinuing a SERM or AI, reasons for discontinuing chemoprevention are reported on the S1904 Breast Cancer Risk-Reducing Pill Usage form.
Time frame: Up to 5 years
Shared decision-making
Will be assessed by a validated 9-item scale with Likert-style responses to assess shared decision-making about chemoprevention. Scores range from 0 to 100. Provider and patient measures are evaluated separately and scored according to their respective validation papers. Will be assessed on the S1904 Patient Shared Decision-Making Questionnaire and on the S1904 Provider Shared Decision-Making Questionnaire.
Time frame: Up to 6 months
Ran from Oct 2020 to primary completion in Sep 2025, 58 months.
Of 38 non-industry interventional studies with no phase under Breast Carcinoma In Situ, half reached primary completion within 63 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 128. This study's 58 months is close to that.
Counting every sponsor, half of 39 studies reached it within 63 months; a quarter within 38 and three quarters within 128.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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