NCT06765707

Symptom Monitoring Using Patient-Report to Improve Medication Use

Symptom Monitoring Using Patient-Reported Outcomes to Optimize Medication Use

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer Early Stage Breast Cancer (Stage 1-3)
• Endocrine Therapy

Interventions

Type	Name	Description
BEHAVIORAL	Pharmacist delivered symptom monitoring and management	Patients in the intervention phase will receive PRO-based symptom monitoring once a month and pharmacist-led management for problematic symptoms based on routine clinical care recommendations.

Timeline

• Start date: 2025-06-23
• Primary completion: 2028-12-01
• Completion: 2029-08-01
• First posted: 2025-01-09
• Last updated: 2025-07-24

Locations

3 sites across 1 country: United States