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

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ClinicalTrials.gov Identifier: NCT04613765
Recruitment Status : Not yet recruiting
First Posted : November 3, 2020
Last Update Posted : November 3, 2020
Sponsor:
Collaborators:
Université Libre de Bruxelles
Fondation Kisane
Les Amis de l'Institut
Information provided by (Responsible Party):
Jules Bordet Institute

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.

Condition or disease Intervention/treatment
Adults Hematological Malignancy Oral Antineoplastic Agents Behavioral: Measure adherence behaviors

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Study Type : Observational
Estimated Enrollment : 113 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : February 28, 2022

Group/Cohort Intervention/treatment
Non-migrants
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.
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.

Other Names:
  • Identify risk factors associated with poor-adherence in each subgroup of non-migrants and migrants
  • Explain any observed differences in adherence rates or associated risk factors between the two subgroups

Migrants
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.
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.

Other Names:
  • Identify risk factors associated with poor-adherence in each subgroup of non-migrants and migrants
  • Explain any observed differences in adherence rates or associated risk factors between the two subgroups




Primary Outcome Measures :
  1. Medication adherence Behaviour [ Time Frame: October 2020-October 2021 ]

    Among the scales able to measure medication-taking behaviour, the Tool for Adherence Behaviour Screening (TABS) screens both intentional and unintentional nonadherence, but also both under and overutilization. Divided in 4 items assessing adherence and 4 assessing non-adherence, all items can be answered by a 5 point-Likert-scale scale (from 'never'=1 to 'always'=5) expressing how often patients manage pharmacological and non-pharmacological disease to ensure adherence.

    Two levels of adherence will be considered (Good adherence: Differential of ≥15 ; Suboptimal adherence: Differential of ≤14) but a continuous variable is measurable by converting TABS scores into ratios of the total score.

    This measure will be repeated at every visits.


  2. Medication adherence Behaviour and Barriers to adherence [ Time Frame: October 2020-October 2021 ]

    The Morisky Medication Adherence Scale (MMAS-8) is both able to measure medication-taking behaviour and identify barriers to adherence.

    This 8 items scale can identify implementation and discontinuation and can also distinct intentional from unintentional adherence. The first seven items have a dichotomous answer (yes/no) that indicates adherent or non-adherent behaviour. For item 8, patient can choose an answer on a 5-point Likert scale, expressing how often happens that a patient does not take his medications. MMAS-8 scores can range from 0 to 8 points. Three levels of adherence may be considered (low: scores of 0 to <6; medium: 6 to <8; high: 8) but a continuous variable is measurable by converting MMAS scores into ratios of the total score. This measure will be repeated at every visits.


  3. Beliefs and Adherence Behaviour [ Time Frame: October 2020-October 2021 ]
    We selected a combination of validated scales eliciting the factors identified as relevant domains of interest in the study of adherence behaviours. Among them, the Beliefs and Behaviour Questionnaire (BBQ) appears particularly relevant for a first exploration of adherence behaviours and barriers to adherence. This useful, simple, socially and culturally relevant 21 close-ended questionnaire covers the various themes of adherence in adequate depth. This questionnaire measure the patient's beliefs and experiences on 5-point-Likert type scales. The Beliefs Section has two subscales of 9 and 5 statements measuring respectively the patients' confidence in their disease management and the concerns about their disease management. Experience section has two subscales of 3 and 5 statements measuring respectively the patients' satisfaction about their management and the patients' disappointment about their management. This measure will be completed on visit 2.

  4. Beliefs about Medicine [ Time Frame: October 2020-October 2021 ]
    The 18 items Beliefs about Medicine Questionnaire (BMQ) allows to quantify and compare patient's personal beliefs about the necessity of their prescribed medication and their concerns about taking it. Patients who believe their medication to be necessary and have more concerns have consistently been shown to be more adherent in a range of diseases. Beliefs about medicines that may influence adherence must therefore be screened when exploring adherence among culturally diverse population.The BMQ is composed of two scales. The BMQ-Specific assessing beliefs about the necessity and the concerns about prescribed medication. The BMQ-General assessing the background general attitudes to medicines (beliefs that medicines are harmful, addictive, poisons which should not be taken continuously and that medicines are overused by doctors) which may determine the These general the person's general orientation to the prescription. This measure will be completed on visit 2.

  5. Therapeutic Alliance [ Time Frame: October 2020-October 2021 ]

    On visit 3, patient completes the Human Connection Scale (HCS) to measure its appraisal of the therapeutic alliance, i.e. the collaborative bond between her or she and its haematologist. This 16-items scale is designed to evaluate the extent to which the patient feels 1) that the oncologist listens to and understands the patient's concerns about the illness 2) that the relationship involves mutual caring and respect 3) that the patient understands the information being shared by the oncologist 4) that the patient trusts the oncologist and 5) that the oncologist and patient work well together.

    For each item, the points of each 4 point-likert-scale answer are summed to give the Human Connection Score possibly ranging from 16 to 64. A higher HCS score indicates a greater Therapeutic Alliance.


  6. Anxiety and Depression [ Time Frame: October 2020-October 2021 ]

    On visit 3, patient also completes the Hospital and Anxiety Depression Scale scale (HADS). Depression, anxiety, fears or anger about the illness can bring about an adverse attitude towards therapy which can affect medication adherence. Our study will invariably enrol patients with various hemopathies and prognosis, more or less far in the lines of treatment, who experience different level of stress or anxiety. The HADS provides a simple reliable tool to screen both anxiety and depression in people with physical health problems. Divided in two scales of 7 items scoring respectively the level of anxiety and depression.

    Analysed separately, scores of each 4 point-Likert-scale answer (0-3) are summed and range from 0 to 21 for anxiety and from 0 to 21 for depression. Cut-off scores are available for each scale for quantification.


  7. Understanding of observed difference in quantitative results between the subgroup of non-migrant and migrant patients [ Time Frame: July 2021 - December 2021 ]
    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. Based on the McGill Illness Narrative interview we will produce narratives that give 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.


Secondary Outcome Measures :
  1. Social Desirability Bias [ Time Frame: October 2020-October 2021 ]

    On first visit, patient completes an auto-administrated social desirability scale. The Social desirability is usually defined as "the tendency of individuals to present themselves favorably with respect to current social norms and standard" and is considered a potential and typical bias in the measurement of self-reported adherence. By adding the Social Desirability Scale-17 (SDS-17) investigators aim to improve their ability to assess whether observed differences may be the reflection of differences in willingness to report such behaviour or beliefs.

    In the 16 items Social Desirability Scale-17 (SDS-17), compared to each statement, the patient is asked to assess if this statement describes him/her or not, answering by "true" or "false". Then points will be summed across items, ranging from 0-16. A higher SDS-17 score indicates a greater social desirability.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613765


Contacts
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Contact: Sandra Michiels, MA +32(0)479284857 sandra.michiels@bordet.be

Locations
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Belgium
CHU Saint Pierre
Brussels, Belgium, 1000
Institut Jules Bordet
Brussels, Belgium, 1000
Sponsors and Collaborators
Jules Bordet Institute
Université Libre de Bruxelles
Fondation Kisane
Les Amis de l'Institut
Investigators
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Study Director: Fati Kirakoya, PhD Université Libre de Bruxelles
Study Director: Sandra Tricas-Sauras, PhD Université Libre de Bruxelles
Publications:
1) Noens et al. (2009). Prevalence, determinants, and outcomes of nonadherence to imatinib therapy in patients with chronic myeloid leukemia: the ADAGIO study. Blood. 113(22), 5401-11. 2) Bhatia et al. (2012). Nonadherence to Oral Mercaptopurine and Risk of Relapse in Hispanic and Non-Hispanic White Children With Acute Lymphoblastic Leukemia: A Children's Oncology Group study. J. Clin. Oncol. 30(17), 2094-101. 3) Ruddy et al. (2009) Patient adherence and persistence with oral anticancer treatment. CA: A Cancer Journal for Clinicians, 59(1):56-66 4) Greer et al. A systematic review of adherence to oral antineoplastic therapies. Oncologist 2016; 21:354-376 5) Hall et al.(2016) To adhere or not to adhere: Rates and reasons of medication adherence in haematological cancer patients, Critical Reviews in Oncology/Hematology. 97:247-262 6) Lepièce (2016). Discrimination dans la consultation médicale interethnique de médecine générale ? (PhD. Thesis), UCL. 7) Van Keer et al. (2015). Conflicts between healthcare professionals and families of a multi-ethnic patient population during critical care: an ethnographic. Critical Care. 19 (441). 8) Van Wieringen et al. (2002). Intercultural communication in general practice. European Journal of Public Health. 12, 63-68 9) Sleath et al. (2003) Hispanic ethnicity physician-patient communication, and antidepressant adherence. Compr Psychiat. 44:198-204. 10) Cooper et al. (2003) Patient-centered communication, ratings of care, and concordance of patient and physician race. Ann Intern Med, 139:907-15. 11) Nieuwkerk PT, et al. Self-reported adherence is more predictive of virological treatment response among patients with a lower tendency towards socially desirable responding. Antivir Ther. 2010;15:913-916. 12) Stöbber (2001) The Social Desirability Scale-17 (SDS-17) European Journal of Psychological Assessment, 17, pp. 222-232 13) George et al. (2005) Development and validation of the Beliefs and Behaviour Questionnaire (BBQ). Patient Education and Counseling.64(1-3): 50-60 14) Garfield et al. Suitability of measures of self-reported medication adherence for routine clinical use: a systematic review. BMC Med Res Methodol. 2011; 11:149. 15) Morisky, D. E., et al. (2008). Predictive Validity of A Medication Adherence Measure in an Outpatient Setting. Journal of Clinical Hypertension (Greenwich, Conn.), 10(5), 348-354. 16) George et al. (2005) Development and validation of the Beliefs and Behaviour Questionnaire (BBQ). Patient Education and Counseling.64(1-3): 50-60 17) Wang et al. Psychometric properties of the 8-item Morisky Medication Adherence Scale in patients taking warfarin. Thromb Haemost 2012; 108: 1-7. 18) Reynolds et al. Psychometric properties of the Osteoporosis-specific Morisky Medication Adherence Scalein postmenopausal women with osteoporosis newly treated with bisphosphonates. Ann Pharmacother 2012; 46: 659-70. 19) Horne, R., et al. Self-regulation and self-management in asthma: exploring the role of illness perceptions and treatment beliefs in explaining non-adherence to preventer medication. Psychol Health 2002; 17: 17-32. 20) Horne et al. (1999). Beliefs about medicines questionnaire (BMQ). Psychology and Health. 14:1-24. 21) Mack et al. (2009) Measuring therapeutic alliance between oncologists and patients with advanced cancer: The human Connection Scale. Cancer. 115 (14):3302-3311 22) Jing et al. Factors affecting therapeutic compliance: A review from the patient's perspective Ther Clin Risk Manag. 2008 Feb; 4(1): 269-286 23) Snaith (2003) The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 1:29. doi:10.1186/1477-7525-1-29 24) Zerbe et al. (1987). Socially desirable responding in organizational behaviour: A reconception.Academy of Management Review, 12, 250-264 25) Cha et al., Translation of scales in cross-cultural research: issues and techniques. Jan Research Methodology, 10.jan 2017, pg.386-395 26) bombardier, F. et al. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol. 1993 Dec; 46(12):1417-32. 27) Groleau et al. (2006). The McGill Illness Narrative Intervew (MINI): an interview schedule to elicit meanings and modes of reasoning related to illness experience. Transcultural Psychiatry, 43(4):671-691. 28) Weiner (1985). 'Sponteneous' causal thinking. Psychology Bulletin, 97, 74-84 29) Krousel-Wood et al. New medication adherence scale versus pharmacy fill rates in seniors with hypertension.Am J Manag Care 2009; 15: 59-66. 30) Ross et al. Patient compliance in hypertension: role of illness perceptions and treatment beliefs. J Hum Hypertens 2004; 18: 607-13 31) Berglund et al. Adherence to and beliefs in lipid-lowering medical treatments: a structural equation modeling approach including the necessity-concern framework. Patient Educ Couns 2013; 91: 105-12. 32) etc.

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Responsible Party: Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT04613765    
Other Study ID Numbers: 3020
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases