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A Mixed Method to Study Adherence to Oral Anticancer Medications in a Multilingual and Multicultural Setting

NCT04613765 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 113

Last updated 2020-11-03

No results posted yet for this study

Summary

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

  • Adults
  • Hematological Malignancy
  • Oral Antineoplastic Agents

Interventions

BEHAVIORAL

Measure adherence behaviors

Conducted in the ambulatory setting of two Brussels hospitals, the MADESIO mixed-method study design combine sequentially a first quantitative explorative questionnaire-based study with a second in depth qualitative approach. The first 4 visits questionnaire-based survey prospectively measures adherence to OAMs and identify associated risk factors in the two sub-groups of ambulatory patients with various haematological malignancies. A combination of validated self-reported measures able to measure medication taking behaviours, assess both intentional and unintentional adherence, identify associated risk factors was selected. The second qualitative phase, based on the McGill Illness narrative interview design, deeper address patients' therapeutic adherence and subjective meanings.

Sponsors & Collaborators

  • Université Libre de Bruxelles

    collaborator OTHER

  • Fondation Kisane

    collaborator UNKNOWN

  • Les Amis de l'Institut

    collaborator UNKNOWN

  • Jules Bordet Institute

    lead OTHER

Principal Investigators

  • Fati Kirakoya, PhD · Université Libre de Bruxelles

  • Sandra Tricas-Sauras, PhD · Université Libre de Bruxelles

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2021-05-31
Completion
2022-02-28

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04613765 on ClinicalTrials.gov