- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05971303
Impact des antécédents culturels et linguistiques sur les soins aux patients et l'expérience des femmes atteintes de tumeurs malignes gynécologiques (iCALD-2)
Examen de l'impact des antécédents culturels et linguistiques divers sur les soins et les expériences des patientes chez les femmes atteintes de tumeurs malignes gynécologiques (iCALD-2) : une étude par questionnaire
Purpose of this study to delineate the attitudes and experiences of patients, interpreters and cancer care professionals involved in the care of oncology patients with gynecologic malignancies with cultural and linguistic diversity backgrounds, in addition to highlighting any barriers to optimal patient care through questionnaires.
Aperçu de l'étude
Description détaillée
Approximately 45% of Toronto residents have a mother tongue other than English, and over a quarter of people speak a language other than English most often at home, with over 180 different languages and dialects spoken throughout the Greater Toronto Area. Additionally, based on the census data from 2016 there also appears to be an unbalanced distribution between minority background and socioeconomic status, with lower income neighborhoods being primarily occupied by visible minority populations, which has been associated with lower socioeconomic status and poorer health literacy, and potentially correlates with healthcare service utilization overall and worse clinical outcomes.
Although linguistically diverse patients in predominantly Caucasian societies is a common phenomenon, it is relatively poorly studied across the globe, although some reports have demonstrated a tendency towards longer inpatient lengths of stay and higher readmission rates. In particular, one retrospective cohort study at two hospital affiliated with the University of Toronto, Canada, found that in over 9000 patients who presented to the emergency room or were admitted, culturally and linguistically diverse (CALD) patients had higher rates of re-presentations and readmissions if their underlying pathology was a chronic condition (chronic airways disease or cardiac failure) due to the complex care pathways involved upon discharge. This is highly relevant to the oncology patient, as consultations are time-restricted and management algorithms are highly complex and involve multiple parallel communication pathways, which carries a higher risk of misinterpretation when coupled with a background where English is not the patient's primary spoken language.
The use of a professional interpreter in medical consultations, defined by the Ontario Council on Community Interpreting (OCCI) as a "fluently bilingual individual with appropriate training and experience who is able to interpret with consistency and accuracy and who adheres to the Standards of Practice and Ethical Principles," has been shown to reduce significantly medical communication errors as compared with ad-hoc family members, improve duration of hospitalization, reduce readmission rates and improve patient satisfaction.
Caring for patients who come from CALD backgrounds poses a unique set of challenges not only from the perspective of the patient, but also for the treating physicians and team of health professionals, including those employed by interpretation services.
The iCALD-2 protocol aims to investigate barriers affecting CALD patient care using a questionnaire approach. Collectively with the iCALD retrospective study, this protocol looks to establish a baseline from which interventional studies surrounding CALD patients and interpretive services can be launched in the future, with a view to potential expansion across other tumour site clinics .
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Cancer Centre
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Patients, interpreters and cancer care professionals involved in the care of oncology patients with gynecologic malignancies with culturally and linguistically diverse (CALD) backgrounds.
La description
Patient Questionnaires:
Inclusion Criteria:
- Patients who have received anti-cancer treatment and continue to be followed up at Princess Margaret Cancer Centre for a confirmed gynecologic malignancy.
- Patients who have received anti-cancer treatment and continue to be followed up at Princess Margaret Cancer Centre for a confirmed gynecologic malignancy.
- Patients self-identify their preferred spoken and/or written language to be a language other than English.
- The patient's self-identified preferred language is one of the languages in which the questionnaire has been translated.
- Patients must be >18 years old.
- Patients must be willing and able to complete a questionnaire (in their primary written language) as a patient in the oncology clinic independently.
- Life expectancy greater than 3 months.
- Patients must be able to provide written consent with the assistance of a professional interpreter.
Exclusion Criteria:
• Patients must be willing and able to complete the questionnaire independently without the assistance of others.
Interpreter Questionnaires:
Inclusion Criteria:
- Interpreters must have provided medical interpretive services in a professional context for at least 3 months.
- Interpreters must be willing and able to complete a questionnaire detailing their demographics and experiences working as a medical interpreter.
- Interpreters must have experience providing medical interpretive services in an oncology or palliative care setting.
Cancer Care Professional Questionnaires:
Inclusion Criteria:
- Physicians must be staff physicians, fellows, physician assistants, or residents in oncology or palliative care, who are experienced in providing medical care to CALD oncology patients in the context of gynecology or palliative care clinics.
- Other cancer care professionals eligible to participate include but are not limited to nurses, clinical research coordinators, social workers, dietitians, pharmacists, psychologists, and administrative staff.
- Cancer care professionals (except for administrative staff) must have had at least 3 months experience providing clinical care in an oncology or palliative care setting, and must have experience delivering care to CALD patients in this context.
- Administrative staff must have at least 3 months experience working in the context of an oncology or palliative care clinic, and must have regular in-person or by phone patient contact. They must also have experience interacting with patients or carers from CALD backgrounds in an oncology/palliative care setting.
- Cancer care professionals must be willing and able to complete a questionnaire independently detailing their demographics and experiences in treating CALD oncology or palliative care patients.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: ECOLOGIC_OR_COMMUNITY
- Perspectives temporelles: CROSS_SECTIONAL
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Patient Questionnaire
Eligible patients will be matched to complete questionnaires in their specified preferred language. Questionnaire patient responses will also be in the patient's identified preferred language, and will be translated into English for study analysis by UHN Interpretation and Translation Services. The questionnaire will comprise of sections in multiple choice and free-text format, administered in an outpatient setting. Question domains will encompass patient demographics, comprehension of diagnosis and treatment, clinical trials, palliative care and overall experiences in the clinic from the perspective of a CALD oncology patient, including identification of any barriers to optimal care. |
Questionnaires will be given to patients, interpreters and cancer car professionals with aims of delineating the attitudes and experiences of patients, interpreters and cancer care professionals involved in the care of oncology patients with gynecologic malignancies |
|
Interpreter Questionnaire
Interpreters will be screened by investigators and approached for their willingness to complete the questionnaires. The questionnaire will comprise of several sections in rating scale and free-text format. Questionnaires will be delivered in English only. Question domains will encompass demographics, professional background, and overall experiences in the clinic setting from the perspective of a professional team member caring for the oncology patient with CALD background, including identification of any barriers to optimal care. |
Questionnaires will be given to patients, interpreters and cancer car professionals with aims of delineating the attitudes and experiences of patients, interpreters and cancer care professionals involved in the care of oncology patients with gynecologic malignancies |
|
Cancer Care Professional Questionnaire
Cancer Care Professionals will be screened by investigators and approached for their willingness to complete the questionnaires. The questionnaire will comprise of several sections in rating scale and free-text format. Questionnaires will be delivered in English only. Question domains will encompass demographics, professional background, and overall experiences in the clinic setting from the perspective of a professional team member caring for the oncology patient with CALD background, including identification of any barriers to optimal care. |
Questionnaires will be given to patients, interpreters and cancer car professionals with aims of delineating the attitudes and experiences of patients, interpreters and cancer care professionals involved in the care of oncology patients with gynecologic malignancies |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
To describe culturally and linguistically diverse (CALD) patient experiences and attitudes in the clinic setting concerning interpretation services, in addition to barriers to providing care and self-management supports.
Délai: 4 to 6 weeks
|
•Eligible patients will be matched to complete questionnaires in their specified preferred language. Question domains will encompass patient demographics, comprehension of diagnosis and treatment, clinical trials, palliative care and overall experiences in the clinic from the perspective of a CALD oncology patient, including identification of any barriers to optimal care. |
4 to 6 weeks
|
|
To describe training processes and challenges faced by interpreters when providing services to oncology and palliative care CALD patients.
Délai: 4 to 6 weeks
|
Questionnaires will be anonymous and delivered in English only. Question domains will encompass demographics, professional background, and overall experiences in the clinic setting from the perspective of a professional team member caring for the oncology patient with CALD background, including identification of any barriers to optimal care. |
4 to 6 weeks
|
|
To describe challenges faced by treating physicians and allied health professionals when providing care to CALD patients in oncology or palliative care clinic settings.
Délai: 4 to 6 weeks
|
Questionnaires will be anonymous and delivered in English only. Question domains will encompass demographics, professional background, and overall experiences in the clinic setting from the perspective of a professional team member caring for the oncology patient with CALD background, including identification of any barriers to optimal care. |
4 to 6 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
To characterize the demographics of the CALD population in the gynecology clinic with regards to visible minority populations and self-reported preferred first languages.
Délai: 4 to 6 weeks
|
Frequencies and proportions for the answers of multiple-choice questions in Oncology clinic experiences, Clinical trials and Palliative care clinic sections of Patient Questionnaire will be calculated and reported. |
4 to 6 weeks
|
|
To compare patient distress levels between different ethnic minorities using Distress Assessment and Response Tool (DART) data from iCALD (UHN Research Ethics Board #20-5032)
Délai: 4 to 6 weeks
|
Patients answer specific questions about physical, emotional and practical challenges that impact with their ability to engage in their cancer care. |
4 to 6 weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Stephanie L'Heureux, University Health Network, Toronto
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 20-5744
Informations sur les médicaments et les dispositifs, documents d'étude
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