This is an intervention targeting patients at risk for non-adherence to endocrine therapy after primary treatments for hormone-positive breast cancer. In a randomized study, the study team will collect patient-reported symptoms monthly from participants through surveys. Pharmacists who specialize in cancer at the patients' hospital will give patients recommendations to help improve their symptoms and address other barriers so they can continue daily endocrine therapy medications.

This study will test whether oncology teams can adapt and combine models from intensive oncologic care and chronic noncancer care to support long-term oral oncologic medication adherence through better symptom monitoring and management. It will identify patients at risk of nonadherence through electronic health records and target them with a symptom monitoring and management intervention. The study will use patient-reported outcomes (PROs) to identify symptoms that may cause nonadherence and will involve clinical pharmacist-led follow-up.

Objectives:

1. Assess the impact of the intervention on adherence to oral endocrine therapy.
2. Evaluate the durability of adherence one-year post-intervention.
3. Describe the impact on symptoms and explore mechanisms for adherence improvement.

Intervention:

During the intervention phase, patients will receive symptom monitoring and pharmacist-led management based on patient-reported outcomes (PROs).

Symptom Monitoring:

1. Patients will report symptoms monthly for 12 months either online or via an interactive voice recording (IVR) system.
2. Symptoms will be assessed using PROs focusing on issues like pain, hot flashes, anxiety, and more.
3. Severe symptoms will trigger follow-up for management.

Symptom Management:

1. After the initial symptom report, patients will have a face-to-face or virtual visit with a clinical pharmacist.
2. The visit will be tailored based on patient preference and pharmacist judgment.
3. Pharmacists will discuss symptom reports, provide management recommendations, and coordinate with oncologists for prescriptions if needed.
4. All interactions will be documented in the electronic health record (EHR) for research analysis.

Control Phase:

Breast cancer patients on AET are typically seen every six months over a 5 to 10-year course, with more frequent visits if complications arise. Control group participants will continue to follow this schedule and receive an FDA document with tips for medication adherence.

Consent Process:

Informed consent will be obtained in person or remotely.

Inclusion Criteria:

• Cisgender women assigned female at birth

• Age 18 years or older

• Stage 1-3 hormone receptor-positive breast cancer

  1. Premenopausal patients being treated with GNRH agonist/antagonist to induce menopause are eligible
  2. Patients who received treatment with CDK 4/6 inhibitors are eligible

• Recommended to continue AET for ≥2 additional years after enrollment

• Low adherence defined as prescription fills with a proportion of days covered (PDC) of <80%, examined over all fills during the 2 years prior to date of eligibility review since the first AET prescription/data of AET start OR unable to calculate adherence

• Verbal fluency in English or Spanish

• Ability to understand informed consent and the willingness to sign it

Exclusion Criteria:

• Unable to verbalize comprehension of study or impaired decision-making
• Known distant metastatic disease
• Not receiving breast cancer care or AET prescription from provider at participating site
• Evidence that an oncology provider discontinued their AET
• Pregnant or trying to get pregnant
• Facility-administered medications (i.e., nursing home, home healthcare agency)

People assigned female at birth who have not received masculinizing hormone therapy (that is, primarily cisgender women) will be included in this study. Although breast cancer occurs in cisgender men, trans women, and trans men, the use of endocrine therapy and its side effects can differ substantially across these groups particularly if they have previously received such therapy. Our intervention is structured around guideline concordant care based on research conducted in primarily cisgender women assigned female at birth, thus they are the primary focus at this stage. Nonbinary or transgender patients who were assigned female at birth and have not received hormone therapy would not, however, be excluded.

For patients who consent to sharing, the cleaned, de-identified, individual-participant level scientific data for all variables used in the analyses that address the specific aims will be shared, along with example transformations from initial raw data.

Shared data generated from this project will be made available no later than 12 months after the funding period ends. The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period.

There are no anticipated factors or limitations that will affect the access, distribution or reuse of the de- identified scientific data generated by the proposal. The de-identified scientific data that is shared will be shared by unrestricted download via Harvard Dataverse.

The statistician will be blinded for outcomes assessment for the 12-month outcomes.