Gynecologic CanceriCALD-2NCT05971303
Impact of Cultural and Linguistic Backgrounds on Patient Care and Experience of Women With Gynecologic Malignancies
An observational study of Gynecologic Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Questionnaire
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 15 Mar 2022to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients, interpreters and cancer care professionals involved in the care of oncology patients with gynecologic malignancies with culturally and linguistically diverse (CALD) backgrounds.
Who may be able to join
- 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.
Show all 17Show fewer
- Life expectancy greater than 3 months.
- Patients must be able to provide written consent with the assistance of a professional interpreter.
- 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:
- 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.
Who cannot join
- Patients must be willing and able to complete the questionnaire independently without the assistance of others.
- Interpreter Questionnaires:
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Impact of Culturally and Linguistically Diverse Backgrounds on Patient Care and Experiences in Women With Gynecologic Malignancies (iCALD-2): A Questionnaire Study
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.
Read the detailed description
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 .
- Conditions
- Gynecologic Cancer
- Being tested
- Questionnaire
- Keywords
- Visible minority, Linguistic Diversity, Cultural Diversity, Socioeconomic Status, Health Literacy, Patient Care, Patient Experience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire | |
| 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. Receives: Other: Questionnaire | |
| 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. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
•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.
Measured: 4 to 6 weeks
To describe training processes and challenges faced by interpreters when providing services to oncology and palliative care CALD patients.
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.
Measured: 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.
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.
Measured: 4 to 6 weeks
Secondary outcomes (2)
To characterize the demographics of the CALD population in the gynecology clinic with regards to visible minority populations and self-reported preferred first languages.
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.
Measured: 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)
Patients answer specific questions about physical, emotional and practical challenges that impact with their ability to engage in their cancer care.
Measured: 4 to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start15 Mar 2022
- Primary completion1 Mar 2024
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie L'Heureux, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971303
- Sponsor's protocol ID
- 20-5744
- Acronym
- iCALD-2
- Status last verified
- Sep 2026
- First submitted
- 31 May 2021
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Culturally and Linguistically Diverse Backgrounds on Patient Care and Experiences in Women With Gynecologic Malignancies (iCALD-2): A Questionnaire Study
- ClinicalTrials.gov ID
- NCT05971303
- Acronym / sponsor ID
- iCALD-2 / 20-5744
- Conditions
- Gynecologic Cancer
- Keywords
- Visible minority, Linguistic Diversity, Cultural Diversity, Socioeconomic Status, Health Literacy, Patient Care, Patient Experience
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 .
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient Questionnaire | – | Other: QuestionnaireEligible 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. |
| Interpreter Questionnaire | – | Other: QuestionnaireInterpreters 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. |
| Cancer Care Professional Questionnaire | – | Other: QuestionnaireCancer 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, interpreters and cancer care professionals involved in the care of oncology patients with gynecologic malignancies with culturally and linguistically diverse (CALD) backgrounds.
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients must be willing and able to complete the questionnaire independently without the assistance of others.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaires 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 | Other | Cancer Care Professional Questionnaire, Interpreter Questionnaire, Patient Questionnaire |
Primary outcome
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.
Time frame: 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.
To describe training processes and challenges faced by interpreters when providing services to oncology and palliative care CALD patients.
Time frame: 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.
To describe challenges faced by treating physicians and allied health professionals when providing care to CALD patients in oncology or palliative care clinic settings.
Time frame: 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.
2 secondary outcomes
To characterize the demographics of the CALD population in the gynecology clinic with regards to visible minority populations and self-reported preferred first languages.
Time frame: 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)
Time frame: 4 to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
Related trials for Gynecologic Cancer
RecruitingPhase 2
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm
Recruiting
INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study
Breast Cancer, Corpus Uteri Cancer
Not yet recruiting
Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers
Non Small Cell Lung Cancer, Melanoma (Skin Cancer)
Enrolling by invitation
Peer Ambassador in Gyn Onc Trials
Ovarian Cancer
RecruitingObservational study
Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network, STOP-VTE Study
Malignant Digestive System Neoplasm, Malignant Female Reproductive System Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie L'Heureux principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 4 to 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.