Clinical trial NCT04613765: A Mixed Method to Study Adherence to Oral Anticancer Medications in a Multilingual and Multicultural Setting
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adults
Hematological Malignancy
Oral Antineoplastic Agents
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
Collaborators: name: Université Libre de Bruxelles
name: Fondation Kisane
name: Les Amis de l'Institut
First posted: 2020-11-03
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Non-Migrant and Migrants with haematological malignancies.

Migrant group is composed of :

"First Generation (FG)" migrants : the group of foreign-born persons "Second Generation (SG)" migrants : the group of people born in Belgium but with either a foreign nationality or with one or both parents foreign-born.

Brief 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.

Detailed description: INTRODUCTION

For some years, the use of OAMs is increasing and oncological teams must deal with the challenge of ensuring optimal adherence to prescribed treatments. It has been demonstrated that poor adherence impacts the quality of response and risk of relapse. However, data are scarce regarding how cancer patients adhere to their medication plan, particularly those with malignancies other than breast cancer. Moreover, oncohaematology appears to be the poor cousin to the cancer adherence studies. Except for CML or 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. This is even more restricting that, studies suggest considerable disparities and difficulties in communication between doctors and patients from different cultural and ethnic backgrounds. Considering that medication adherence is a complex interplay of predisposing factors, patients' knowledge and beliefs and patient-physician interactions, the underrepresentation of the key population of Migrants and Ethnic Minorities in adherence studies in oncology is critical.

In the context of increasing migration and emergence of novel oral therapeutics, it becomes urgent to identify potential differences in access, use and the quality of care that may lead to disparities in health outcomes. With the MADESIO Protocol, the investigators aim to fill this unmet need and to assess whether and why in oncohaematology, patients with migrant backgrounds are a risk group regarding adherence to OAMs.

OBJECTIVES

The primary objective of investigators is to measure the prevalence of medication adherence and persistence to OAMs in two subgroups of migrants and non-migrants with haematological malignancies. Additionally, in each subgroup, the study aims to identify the associated risk factors of adherence. Finallly, investigators aim to explain any observed differences between the 2 subgroups.

DESIGN

The MADESIO protocol is based on a prospective sequential mixed method study design able of tackling the challenges of studying adherence in haematology and in patients from diverse linguistic and cultural backgrounds.

Conducted in the ambulatory setting of two Brussels hospitals, the MADESIO design combines sequentially a first quantitative explorative questionnaire-based survey 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 two sub-groups of 60 migrant and 53 non-migrant ambulatory patients with various haematological malignancies. The second qualitative semi-structured interviews deeper address patients' therapeutic adherence and subjective meanings.

CLINICAL SETTING

The Institut Jules Bordet and the Centre Hospitalier Universitaire Saint-Pierre are two nearby hospitals. Located in the hearth of Brussels, their oncohaematological outpatient settings offer an ideal setting to explore the topic of migrants' adherence in the context of interethnic or intercultural medical consultations.

STUDY POPULATION

Eligible patients are adult patients with an haematological malignancy, having taken at least one OAM since minimum 30 days and having a minimum of 6 months life expectancy.

The sub-group of migrants is composed of "First Generation (FG)" migrants - the group of foreign-born persons - and of "Second Generation (SG)" migrants which are people born in Belgium but with either a foreign nationality or with one or both parents foreign-born.

QUANTITATIVE APPROACH - QUESTIONNAIRE-BASED STUDY VISITS:

Each patient will answer different questionnaires across 4 visits. Over one year will be necessary to include the 113 patients and over 18 months to cover the follow-up duration.

During the first information visit, the researcher obtains patient informed consent and collects full socio-demographic, socio-economic, linguistic and migratory characteristics. All subsequent questionnaires are self-administrated.

A combination of validated self-reported measures was selected because designed to measure medication taking behaviours, assess both intentional and unintentional adherence, identify barriers and levers to adherence, not excluding contextual and socioeconomic factors, patients beliefs or patients' appraisal of the collaborative bond with its haematologist.

1/ The Beliefs and Behaviour questionnaire (BBQ); 2/ the Tool for Adherence Behaviour Screening (TABS); 3/ The Morisky Medication Adherence Scale-8 (MMAS-8), 4/ The Beliefs about Medicine Questionnaire (BMQ); 5/ the Human Connection Scale (HCS);and 6/ the Hospital Anxiety and Depression Scale (HADS) was also added to screen both anxiety and depression as they can affect adherence to medications.

The TABS and MMAS-8 aiming to measure adherence behaviour are repeated at every visit. Other selected questionnaires aiming to explore the associated risk factors are distributed across the next three visits. The schedule of the next three visits is adapted according to the usual follow-up frequency of the patient. Depending on the malignancy, patients are usually monitored every one, two or three months. Visit 2 might be on Month 1, 2 or 3, visit 3 on Month 3, 4 or 6 and visit 4 to Month 6 or 9. A last questionnaire aims to capture the trend of individuals to social desirability.

At every visit, diagnosis, disease stage, prescribed drug regimen, side effects, concomitant medications, comorbidities and performance status are collected from patient medical record. After consultation, the haematologist completes contextual information regarding the presence of family members, language(s) used in communicating, assistance of an (non)-professional interpreter, and estimates the patient's level of French proficiency and the duration of the consultation.

PATIENT SELECTION AND ENROLLMENT

The researcher has access to the consultations' planning and the patients' medical file to identify potentially eligible patients. All of them are listed and selected in running order

During an initial phone contact, the researcher briefly explains the purpose of the study. If the patient agrees, a half-hour information visit is scheduled during the next regular follow-up visit. In case of language barrier, the contact person mentioned in the patient's medical file is joined and the information visit is organized in the presence of an intercultural mediator.

Questionnaires are distributed by the researcher just after the blood test, usually scheduled one to two hours before the medical consultation. All questionnaires are pre-coded with the patient study number and visit date and given to the patient in an pre-coded study envelope. The patient can then complete the questionnaires at its best convenience during the hospital visit and slide it into one of the numerous mailbox before leaving the hospital.

TRANSLATION AND VALIDATION OF THE QUESTIONNAIRES

Already validated translated versions existed in the five target languages (French, Dutch, Arabic, Polish, Romanian) for the HADS and were obtained after the licence fees. For other non-translated questionnaires, consistent with available resources and international guidelines, the investigators established a rigorous, appropriate and user-friendly valid translation method.

Forward Translation : The initial translation from the original language has been made by a professional translator, familiar with health and medical terminologies. Instructions were given in the approach to translating, emphasizing conceptual rather than literal translations, as well as the need to use natural and acceptable language for the broadest audience.

Back Translation : Using the same approach, the instrument was then converted back to English by an independent translator whose mother tongue was English and who was not familiar with the questionnaire.

Both source-questionnaire in English and Backward translation were submitted for comparison to the main researcher. Each item of the two versions were ranked in terms of comparability of language and similarity of interpretability. All discrepancies, misunderstandings or unclear wording revealed by the back-translation were discussed with a third independent translator and again translated if needed.

Preliminary pilot testing : The researcher pilot tested the prefinal version of the translation with cognitive debriefing on, first one bilingual patient with an haematological malignancy and, second, one bilingual nurse in oncology.

All suggestions for linguistic and cultural adaptation were discussed with the researcher, the two bilingual respondents and the third professional translator until a consensus is reached.

QUALITATIVE APPROACH - McGill ILLNESS NARRATIVE INTERVIEWS(MINI):

Quantitative research methods have significant limitations in capturing the complexity of human behaviour and experience, tending to ignore the social and discursive contexts in which individual and collective understandings of illness experience emerge. Understanding the meaning that haematological cancer patients give to their illness and treatment experience may be crucial to explain the statistical associated between variables observed in quantitative study.

According to an explanatory design, MADESIO study is a two-phase mixed methods design. Qualitative data will help to explain initial quantitative results. Given the lack of previous available data the two phases will be connected at two levels. A 6 months intermediate analysis of quantitative results will, on the one hand, instruct the appropriate participants to be selected for qualitative study, and on the other hand,will focus the results that need to be examined in more details. At this stage, it cannot be said whether adherence rates or associated risk factors will be different in the migrant and non-migrant subgroups. But whatever, qualitative study aims to understand why these results differ or not.

The MINI will guide the conversation and produce narratives given access the many representations that come into play with regards to illness and health-related behaviour. Especially, addressing the discursive contexts in which individual and collective understandings of illness experience emerge may contribute to understand any potential association between personal or cultural beliefs and adherence behaviours. Therefore, the structured dimension of the MINI will enable the comparison between groups of patients from different cultural background.

Sampling the selection criteria will be designed based on the first results of the quantitative study. The research team considers selecting outliers from the regression analysis or decide to learn more about the differences between people who score either high or low on adherence variables. Considering the risk of relapse or death of cancer patients treated by oral anticancer medication, the researcher will further decide to recontact appropriate members of our original quantitative sample, or to draw a new sample that meets our purposive criteria.

CONCLUSION:

When building this protocol, investigators are aware of the complexity, if only for practical reasons, of studying prospectively adherence in patients with a language barrier. Using a mixed method approach, the MADESIO protocol is able to generate solid complementary information on adherence behaviour and associated determinants among both non-migrant and migrants patients with various haematological malignancies.

Successfully addressing the challenges raised by adherence study in haematology and in minority diverse populations, this sequential mixed method design will provide a first overview of how non-migrants and migrants with haematological malignancies, in our two Brussels Hospitals, adhere to their OAMs and will contribute to understand whether and why FG and SG migrants constitute a specific population regarding adherence to OAMs.

Eligibility criteria: 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

Primary outcomes:
measure: Medication adherence Behaviour
timeFrame: October 2020-October 2021
measure: Medication adherence Behaviour and Barriers to adherence
timeFrame: October 2020-October 2021
measure: Beliefs and Adherence Behaviour
timeFrame: October 2020-October 2021
measure: Beliefs about Medicine
timeFrame: October 2020-October 2021
measure: Therapeutic Alliance
timeFrame: October 2020-October 2021
measure: Anxiety and Depression
timeFrame: October 2020-October 2021
measure: Understanding of observed difference in quantitative results between the subgroup of non-migrant and migrant patients
timeFrame: July 2021 - December 2021
Secondary outcomes:
measure: Social Desirability Bias
timeFrame: October 2020-October 2021
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Saint Pierre
city: Brussels
country: Belgium
facility: Institut Jules Bordet
Study officials:
affiliation: Université Libre de Bruxelles
name: Fati Kirakoya, PhD
role: STUDY_DIRECTOR
affiliation: Université Libre de Bruxelles
name: Sandra Tricas-Sauras, PhD
role: STUDY_DIRECTOR
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