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 — BEHAVIORALPatients 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 ManagementPatients 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 CarePatients 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Illinois Chicago | Chicago | Illinois | 60612 | - |
| Mayo Clinic | Rochester | Minnesota | 55905 | - |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 26509 | - |
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