Symptom Monitoring Using Patient-Report to Improve Medication Use

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:

• Assess the impact of the intervention on adherence to oral endocrine therapy.
• Evaluate the durability of adherence one-year post-intervention.
• 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:

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

Symptom Management:

• After the initial symptom report, patients will have a face-to-face or virtual visit with a clinical pharmacist.
• The visit will be tailored based on patient preference and pharmacist judgment.
• Pharmacists will discuss symptom reports, provide management recommendations, and coordinate with oncologists for prescriptions if needed.
• 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

• Premenopausal patients being treated with GNRH agonist/antagonist to induce menopause are eligible
• 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)