Symptom Monitoring Using Patient-Report to Improve Medication Use

NCT ID: NCT06765707

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-23
• Study Completion Date: 2029-08-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Usual Care first, Then Symptom Monitoring and Management

Patients first receive care as usual which includes follow-up with their oncology team first 12 months of the study. Following data collection at 12 months they will then receive symptom monitoring and management for the second 12 months of the study.

Group Type: EXPERIMENTAL

Pharmacist delivered symptom monitoring and management

Intervention Type: BEHAVIORAL

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.

Symptom Monitoring and Management first, Then Usual Care

Patients first receive symptom monitoring and management for the first 12 months of the study. After data collection at 12 months they will then receive care as usual which includes follow-up with their oncology for the second 12 months of the study.

Group Type: EXPERIMENTAL

Pharmacist delivered symptom monitoring and management

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Kathryn Flynn

Vice Chair, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Illinois Chicago

Chicago, Illinois, United States

Mayo Clinic

Rochester, Minnesota, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

Neuner J, Weil E, Fergestrom N, Stolley M, Kamaraju S, Oxencis C, Winn A, Laud PW, Flynn KE. Feasibility of a pharmacist-led symptom monitoring and management intervention to improve breast cancer endocrine therapy adherence. J Am Pharm Assoc (2003). 2022 Jul-Aug;62(4):1321-1328.e3. doi: 10.1016/j.japh.2022.03.001. Epub 2022 Mar 5.

Reference Type: BACKGROUND

PMID: 35393248 (View on PubMed)

Other Identifiers

1R01CA285925-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO00051010

Identifier Type: -

Identifier Source: org_study_id