Symptom Monitoring Using Patient-Report to Improve Medication Use (SyMPTOM)

Symptom Monitoring Using Patient-Reported Outcomes to Optimize Medication Use

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Endocrine Therapy; Breast Cancer Early Stage Breast Cancer (Stage 1-3)
• Intervention / Treatment: Behavioral: Pharmacist delivered symptom monitoring and management

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 Type: Interventional
• Enrollment (Estimated): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois Chicago
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 26509
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication adherence	Defined as the proportion of total days' pills taken by patients measured by the opening of an electronic pill monitoring cap	From baseline to 12 months
Intervention durability on medication adherence	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	From 12 to 24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: December 27, 2024
• First Submitted That Met QC Criteria: January 3, 2025
• First Posted (Actual): January 9, 2025

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: symptom management; symptom monitoring; pharmacist delivered intervention; oral endocrine therapy adherence
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PRO00051010; 1R01CA285925-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No