An interventional study of Pharmacist delivered symptom monitoring and management in Breast Cancer Early Stage Breast Cancer (Stage 1-3) and Endocrine Therapy, sponsored by Medical College of Wisconsin. Enrolling by invitation at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Supportive care
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.
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:
Intervention:
During the intervention phase, patients will receive symptom monitoring and pharmacist-led management based on patient-reported outcomes (PROs).
Symptom Monitoring:
Symptom Management:
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.
Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Stage 1-3 hormone receptor-positive breast cancer
Exclusion Criteria:
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 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.
Medication adherence
Defined as the proportion of total days' pills taken by patients measured by the opening of an electronic pill monitoring cap
Time frame: 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
Time frame: From 12 to 24 months
Medication adherence
Medication adherence, based on prescription fill data (percent days covered, as used in screening)
Time frame: From baseline to 12 months
Pain
Patient-report collected via PROMIS Pain Interference measure
Time frame: From baseline to 24 months
Fatigue
Patient-report collected via PROMIS Fatigue measure
Time frame: From baseline to 24 months
Sleep
Patient-report collected via PROMIS Sleep-related Impairment measure
Time frame: From baseline to 24 months
Anxiety
Patient-report collected via PROMIS Anxiety measure
Time frame: From baseline to 24 months
Depression
Patient-report collected via PROMIS Depression measure
Time frame: From baseline to 24 months
Sexual function
Patient-report collected via PROMIS Sexual Function and Satisfaction measure
Time frame: From baseline to 24 months
Physical functioning
Patient-report collected via PROMIS Physical Functioning measure.
Time frame: From baseline to 24 months
Social functioning
Patient-report collected via PROMIS Ability to Participate in Social Roles and Activities measure
Time frame: From baseline to 24 months
Self-efficacy to manage medications
Patient-report collected via PROMIS Self-efficacy to Manage Medications measure
Time frame: From baseline to 24 months
Self-efficacy to manage symptoms
Patient-report collected via PROMIS Self-efficacy to Manage Symptoms measure
Time frame: From baseline to 24 months
Social support
Patient-reported collected via PROMIS Instrumental Support measure
Time frame: From baseline to 24 months
Team-patient communication quality
Team-patient communication quality collected using The Communication Assessment Tool
Time frame: From baseline to 12 months
Plan to share: Yes — 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.
Supporting information: Study protocol
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical College of Wisconsin