Symptom Monitoring Using Patient-Report to Improve Medication Use

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Medical College of Wisconsin
Study ID
NCT06765707
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 23, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2028
Completion
Aug 31, 2029

Study Design

Enrollment
225 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.
  • 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.

Primary Outcome Measure

Medication adherence [ Time Frame: From baseline to 12 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of Illinois ChicagoChicagoIllinois60612-
Mayo ClinicRochesterMinnesota55905-
Medical College of WisconsinMilwaukeeWisconsin26509-

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