Clinical trial · Interventional
Symptom Monitoring Using Patient-Report to Improve Medication Use
Symptom Monitoring Using Patient-Reported Outcomes to Optimize Medication Use
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Early Stage Breast Cancer (Stage 1-3) | — | UNRESOLVED | — |
| Endocrine Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pharmacist delivered symptom monitoring and management | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Usual Care first, Then Symptom Monitoring and Management
- description
- 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.
- interventionNames
- Behavioral: Pharmacist delivered symptom monitoring and management
- type
- EXPERIMENTAL
- label
- Symptom Monitoring and Management first, Then Usual Care
- description
- 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.
- interventionNames
- Behavioral: Pharmacist delivered symptom monitoring and management
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- BACKGROUNDNeuner 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