Clinical trial · Interventional
EHR-embedded OCDT in Breast or GI Cancer
Nonrandomized Phase II Hybrid Type 3 Implementation Study: Feasibility and Acceptance of an EHR-embedded Oral Cancer Directed Therapy Toxicity and Adherence Program for Patients With Breast or Gastrointestinal Cancer
- 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 research study is for participants with advanced breast or gastrointestinal cancer who have been taking oral chemotherapy medication (Oral Cancer Directed Therapy). This study is to help researchers better understand gaps in assessing oral chemotherapy patient toxicity at home, adherence to treatment and integrate toxicity/adherence reporting.
Conditions
Conditions (4)
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Oral Cancer Directed Therapy | — | UNRESOLVED | — |
| Oral Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Care Team Alert | Other | — | UNRESOLVED |
| Passive Care Team Alert | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Passive Care Team Alert
- description
- DFCI patients with advanced breast or gastrointestinal cancer prescribed Oral Cancer Directed Therapy. * Screening: ePRO Clinic:-- complete ePRO clinic for all medical oncology scheduled provider appointments during the study period per standard practice * ePRO Home: -- ePRO oral between visits at home. * Passive care team alert -- EHR inBasket notification
- interventionNames
- Other: Passive Care Team Alert
- type
- OTHER
- label
- Active Care Team Alert
- description
- DFCI patients with advanced breast or gastrointestinal cancer prescribed Oral Cancer Directed Therapy. * Screening: ePRO Clinic:-- complete ePRO clinic for all medical oncology scheduled provider appointments during the study period per standard practice * ePRO Home: -- ePRO oral between visits at home. * Active care team alert -- practice nurse monitoring of ePRO home responses score = 3 indicating a moderate-severe toxicity (grade 3 or higher
- interventionNames
- Other: Active Care Team Alert
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult age 18 or older * Male or Female * Scheduled visit at DF/HCC within the BOC or GCC * Diagnosis of advanced breast cancer or gastrointestinal cancer * Prescribed any OCDT within prior 5 days of screening * English as the primary language (as documented in the EHR, written or spoken, and patient interpreter needed flag = no) * Mobile number listed in EHR to allow participation in ePP portion of the study * Women of any pregnancy status * Patients diagnosed with an advanced cancer will be eligible to participate in the study until discontinuation of OCDT or death, whichever occurs first Exclusion Criteria * Adults unable to provide verbal consent * Pediatric patients * Patients without access to a electronic device (including tablet, computer, aptop or smartphone)
References
Publications (0)
Data not yet available