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 |
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Recruitment Status :
Not yet recruiting
First Posted : November 3, 2020
Last Update Posted : November 3, 2020
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| Condition or disease | Intervention/treatment |
|---|---|
| Adults Hematological Malignancy Oral Antineoplastic Agents | Behavioral: Measure adherence behaviors |
Show detailed description
| 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 |
|---|---|
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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.
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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:
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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.
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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:
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 |
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.
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
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
| Contact: Sandra Michiels, MA | +32(0)479284857 | sandra.michiels@bordet.be |
| Belgium | |
| CHU Saint Pierre | |
| Brussels, Belgium, 1000 | |
| Institut Jules Bordet | |
| Brussels, Belgium, 1000 | |
| Study Director: | Fati Kirakoya, PhD | Université Libre de Bruxelles | |
| Study Director: | Sandra Tricas-Sauras, PhD | Université Libre de Bruxelles |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Hematologic Neoplasms Neoplasms Neoplasms by Site Hematologic Diseases |

