Symptom Monitoring Using Patient-Report to Improve Medication Use

NCT06765707 | Enrolling By Invitation DMC

• 2 other identifiers: PRO000510101R01CA285925-01A1
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

symptom management; symptom monitoring; pharmacist delivered intervention; oral endocrine therapy adherence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Medication adherence

  From baseline to 12 months

• Pain

  From baseline to 24 months

• Fatigue

  From baseline to 24 months

• Sleep

  From baseline to 24 months

• Anxiety

  From baseline to 24 months

Study Arms (2)

Usual Care first, Then Symptom Monitoring and Management

EXPERIMENTAL

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

Symptom Monitoring and Management first, Then Usual Care

EXPERIMENTAL

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

Interventions

Pharmacist delivered symptom monitoring and management 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; Usual Care first, Then Symptom Monitoring and Management

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: People assigned female at birth who have not received masculinizing hormone therapy (that is, primarily cisgender women) will be included in this study. Although breast cancer occurs in cisgender men, trans women, and trans men, the use of endocrine therapy and its side effects can differ substantially across these groups particularly if they have previously received such therapy. Our intervention is structured around guideline concordant care based on research conducted in primarily cisgender women assigned female at birth, thus they are the primary focus at this stage. Nonbinary or transgender patients who were assigned female at birth and have not received hormone therapy would not, however, be excluded.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 26509, United States

Location

Related Publications (1)

• 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.

  PMID: 35393248 BACKGROUND

MeSH Terms

Interventions

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician will be blinded for outcomes assessment for the 12-month outcomes.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair, Professor

Model Details: Multi-center, two-arm cross-over, randomized control trial

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 9, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

US (3)