Clinical trial · Observational
A Mixed Method to Study Adherence to Oral Anticancer Medications in a Multilingual and Multicultural Setting
A Mixed Method Study Design to Explore Adherence of Haematological Cancer Patients to Oral Anticancer Medication in a Multilingual and Multicultural Outpatient Setting: the MADESIO Protocol
- 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)
Patients with haematologic malignancies are increasingly treated by Oral Anticancer Medications (OAMs), increasing the challenge of ensuring optimal adherence to treatment. However, except for Chronic Myelogenous Leukemia (CML) or Acute Lymphoid Leukemia (ALL), the extent of non-adherence has rarely been investigated in an outpatient setting. In Belgium, the only available data suffers from critical underrepresentation of patients from minority diverse population. In the context of increasing migration, the identification of differences in access and drug use that may lead to health disparities is crucial. Based on a sequential mixed method study design, our objectives are to measure adherence to OAMs in two subgroups of non-migrants and migrants with various haematological malignancies, to identify the associated risk factors and to explore the representations that come into play with regards to illness and adherence behaviors. Essentially, the MADESIO protocol will contribute to assess whether and why patients with migrant backgrounds are a risk group regarding adherence to OAMs.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adults | — | UNRESOLVED | — |
| Hematological Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Oral Antineoplastic Agents | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Measure adherence behaviors | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Non-migrants
- description
- 53 non-migrant patients will be enrolled. "Non-migrants" will be defined as the group of native-born persons with a Belgian nationality or with a foreign nationality but with both parents native-born.
- interventionNames
- Behavioral: Measure adherence behaviors
- label
- Migrants
- description
- 60 migrant patients will be enrolled. This group will include both "First Generation (FG) migrants" defined as the group of foreign-born persons and "Second Generation (SG) migrants" defined as people native-born but with either a foreign nationality or with one or both parents foreign-born.
- interventionNames
- Behavioral: Measure adherence behaviors
Primary outcomes (7)
- measure
- Medication adherence Behaviour
- timeFrame
- October 2020-October 2021
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA: * Adult (≥ 18) * Any diagnosis of haematological malignancy * Treatment by minimum one OAM * Treatment since minimum 30 days * At least 6 months of life expectancy. * Being able to speak and read French, Dutch, English, Polish, Romanian, or Arabic. EXCLUSION CRITERIA: * Illiterate patient. * Uncontrolled acute psychiatric disease
References
Publications (1)
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