Clinical trial · Interventional
Oral Adherence in Hematological Oncology Agents and Impact on Comorbid Therapy Adherence
- 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)
The objective of this study is to improve medication, symptom, and disease management of patients with hematological malignancies and multiple chronic conditions (2 or more conditions in addition to cancer) through care coordination between pharmacists working in oncology practices and those working in primary care or community practices (Pharmacists Coordinated care Oncology Model \[PCOM\]). This is a pilot study in which the investigators will examine the association between outcome measures, but the study design and sample size are insufficient to quantify the impact of OAA initiation or OAA adherence on adherence to chronic medications. This pilot study and data analyses are being done in preparation for a larger, controlled study.
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 |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Multiple Chronic Conditions | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comprehensive Medication Review | Other | — | UNRESOLVED |
| Patient-reported outcome measure | Other | — | UNRESOLVED |
| Pharmacist communication | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pharmacist Coordinated care Oncology Model
- description
- The Pharmacist Coordinated care Oncology Model includes patient self-reported symptoms and medication adherence, comprehensive medication review(s) and intentional communication between oncology and community pharmacists.
- interventionNames
- Other: Patient-reported outcome measure
- Other: Comprehensive Medication Review
- Other: Pharmacist communication
Primary outcomes (2)
- measure
- Oral anticancer agent adherence by proportion of days covered (PDC)
- timeFrame
- Up to 6 months post-initiation
- description
- PDC is a common medication adherence metric, and assesses the ratio of number of days the patient is supplied with oral anticancer agent, from the time of initiation until 6 months later, to the total number of days during that period. Data from the electronic medical record for dose changes will be aligned with the refill data to calculate a dose-adjusted PDC.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Receiving cancer care at Vanderbilt University Medical Center * Diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), chronic myeloid leukemia (CML), or multiple myeloma (MM) * Initiating an oral anticancer agent, either for the first time or a change from previous oral agent * Diagnosis of 2 chronic conditions, including at least one of the following: diabetes, hypertension, hyperlipidemia, congestive heart failure, depression/anxiety, gastroesophageal reflux disease, and/or chronic obstructive pulmonary disease * Patients taking at least two chronic medications, including at least one medication for one of the conditions listed above. * Willing and able to sign informed consent. Exclusion Criteria: * Cannot communicate in English * Concurrent diagnosis of type 1 diabetes or human immunodeficiency virus
References
Publications (0)
Data not yet available