Clinical trial · Interventional
A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)
Adjuvant Endocrine Therapy in Breast Therapy in Breast Cancer: A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)
- 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)
Background: In women with hormone receptor positive (HR+) breast cancer, adjuvant endocrine therapy (AET) is associated with a significant survival advantage. Nonadherence is a particular challenge in older women, even though they stand to benefit the most from AET. Therefore, a novel e-health tool (OPTIMUM) that integrates real-time analysis of health administrative claims data was developed to provide point-of-care decision support for clinicians.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Medication Adherence | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OPTIMUM e-health tool | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Site
- description
- The hospital that will be the intervention site will have access to the OPTIMUM e-health tool. The intervention site cancer care team will receive the following OPTIMUM e-health alerts: 1. An electronic alert of increased Adjuvant Endocrine Therapy discontinuation risk. 2. An adherence to Adjuvant Endocrine Therapy monitor. 3. An electronic discontinuation occurrence alert
- interventionNames
- Other: OPTIMUM e-health tool
- type
- NO_INTERVENTION
- label
- Control Site
- description
- The hospital that will be the control site will not have access to the OPTIMUM e-health tool. The cancer care team will continue to deliver care according to standard processes.
Primary outcomes (1)
- measure
- Proportion of patients discontinuing adjuvant endocrine therapy treatment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Must be ≥ 65 years old, 2. Have been diagnosed with incident (non-metastatic) breast cancer, 3. Have a histologically-confirmed breast adenocarcinoma, 4. Have undergone breast surgery for stages I-III disease, 5. Have medical insurance with the Régie de l'Assurance Maladie du Québec (RAMQ) for at least 1 year prior to surgery, 6. Have HR positive disease, 7. Have no history of AET use prior to the diagnosis of breast cancer, 8. Expected to initiate AET or have only recently initiated AET (\<6 months) but are free of previous discontinuation events, 9. Have the ability to consent for herself. Exclusion Criteria: male gender
References
Publications (0)
Data not yet available