Symptom Monitoring Using Patient-Report to Improve Medication Use

Not Applicable

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

• Registration Number: NCT06765707
• Lead Sponsor: Medical College of Wisconsin

Brief 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.

Study Timeline

• Study First Submitted: 2024-12-27
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-03
• Study First Posted: 2025-01-09
• Study Start: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Primary Completion: 2028-07
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 225

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Medication adherence	From baseline to 12 months	Defined as the proportion of total days' pills taken by patients measured by the opening of an electronic pill monitoring cap
Intervention durability on medication adherence	From 12 to 24 months	Assess the durability of AET adherence 1 year post intervention on patients assigned to the intervention phase first. Defined as the proportion of total days' pills taken by patients measured by the opening of an electronic pill monitoring cap

Secondary Outcome Measures

Name	Time	Method
Team-patient communication quality	From baseline to 12 months	Team-patient communication quality collected using The Communication Assessment Tool
Self-efficacy to manage symptoms	From baseline to 24 months	Patient-report collected via PROMIS Self-efficacy to Manage Symptoms measure
Social support	From baseline to 24 months	Patient-reported collected via PROMIS Instrumental Support measure
Medication adherence	From baseline to 12 months	Medication adherence, based on prescription fill data (percent days covered, as used in screening)
Pain	From baseline to 24 months	Patient-report collected via PROMIS Pain Interference measure
Fatigue	From baseline to 24 months	Patient-report collected via PROMIS Fatigue measure
Sleep	From baseline to 24 months	Patient-report collected via PROMIS Sleep-related Impairment measure
Anxiety	From baseline to 24 months	Patient-report collected via PROMIS Anxiety measure
Depression	From baseline to 24 months	Patient-report collected via PROMIS Depression measure
Sexual function	From baseline to 24 months	Patient-report collected via PROMIS Sexual Function and Satisfaction measure
Physical functioning	From baseline to 24 months	Patient-report collected via PROMIS Physical Functioning measure.
Social functioning	From baseline to 24 months	Patient-report collected via PROMIS Ability to Participate in Social Roles and Activities measure
Self-efficacy to manage medications	From baseline to 24 months	Patient-report collected via PROMIS Self-efficacy to Manage Medications measure

Trial Locations

Locations (3)

University of Illinois Chicago; 🇺🇸 Chicago, Illinois, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States