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Questionnaire for Gynecologic Cancers (iCALD-2 Trial)

N/A

Recruiting

Led By Stephanie L'Heureux

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 to 6 weeks

Awards & highlights

iCALD-2 Trial Summary

This trial aims to understand cultural and language barriers to cancer care for people with diverse backgrounds.

Who is the study for?

This trial is for adults over 18 with gynecologic cancers at Princess Margaret Cancer Centre, who prefer a non-English language that matches the translated questionnaires. Participants include patients, interpreters with medical experience, and oncology care professionals like nurses and doctors. They must be able to complete a questionnaire and have relevant experience in their roles.Check my eligibility

What is being tested?

The study uses questionnaires to understand the impact of cultural and linguistic diversity on patient care in gynecologic cancer treatments. It aims to identify barriers faced by patients whose preferred language isn't English, as well as experiences of interpreters and healthcare providers.See study design

What are the potential side effects?

Since this trial involves completing questionnaires rather than medical interventions or drugs, there are no physical side effects associated with participation.

iCALD-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 to 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 to 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 to 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To describe challenges faced by treating physicians and allied health professionals when providing care to CALD patients in oncology or palliative care clinic settings.

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.

To describe training processes and challenges faced by interpreters when providing services to oncology and palliative care CALD patients.

Secondary outcome measures

To characterize the demographics of the CALD population in the gynecology clinic with regards to visible minority populations and self-reported preferred first languages.

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)

Side effects data

From 2019 Phase 2 trial • 60 Patients • NCT02060370

83%

Fatigue

76%

Diarrhea

61%

Platelet count decreased

58%

White blood cell decreased

54%

Mucositis oral

54%

Hand-foot syndrome

54%

Anemia

46%

Dysgeusia

44%

Nausea

41%

Rash

39%

Proteinuria

39%

Neutrophil count decreased

36%

Creatinine increased

32%

Aspartate aminotransferase increased

27%

Hypertension

25%

Hypothyroidism

24%

Vomiting

22%

Dyspepsia

20%

Hypoalbuminemia

20%

Anorexia

20%

Dyspnea

20%

Skin hypopigmentation

19%

Alanine aminotransferase increased

17%

Watering eyes

15%

Edema

14%

Weight loss

14%

Oral dysesthesia

14%

Epistaxis

14%

Pruritus

12%

Hyperglycemia

12%

Gastroesophageal reflux disease

12%

Lymphocyte count decreased

12%

Hypocalcemia

10%

Alkaline phosphatase increased

10%

Blood bilirubin increased

10%

Constipation

10%

Dysesthesia

10%

Headache

Hyponatremia

TSH increased

Dry skin

Anal mucositis

Hypomagnesemia

Hair hypopigmentation

Myalgia

Dry mouth

Non-cardiac chest pain

Paresthesia

Alopecia

Bloating

Thromboembolic event

CD4 lymphocytes decreased

Hyperkalemia

Thrombotic thrombocytopenic purpura

Abdominal pain

Hemoglobinuria

Dehydration

Vascular access complication

Hypophosphatemia

Gout

Pancreatic insufficiency

Urticaria

100%

80%

60%

40%

20%

Study treatment Arm

Sunitinib

iCALD-2 Trial Design

3Treatment groups

Experimental Treatment

Group I: Patient QuestionnaireExperimental Treatment1 Intervention

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.

Group II: Interpreter QuestionnaireExperimental Treatment1 Intervention

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.

Group III: Cancer Care Professional QuestionnaireExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,476 Previous Clinical Trials

485,112 Total Patients Enrolled

5 Trials studying Gynecologic Cancers

1,340 Patients Enrolled for Gynecologic Cancers

Stephanie L'HeureuxPrincipal InvestigatorUniversity Health Network, Toronto

Media Library

Interpreter Questionnaire Clinical Trial Eligibility Overview. Trial Name: NCT05971303 — N/A

Gynecologic Cancers Research Study Groups: Interpreter Questionnaire, Patient Questionnaire, Cancer Care Professional Questionnaire

Gynecologic Cancers Clinical Trial 2023: Interpreter Questionnaire Highlights & Side Effects. Trial Name: NCT05971303 — N/A

Interpreter Questionnaire 2023 Treatment Timeline for Medical Study. Trial Name: NCT05971303 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there available slots for individuals to enroll in this trial?

"According to the clinicaltrials.gov website, this research endeavour is presently enrolling volunteers; it was first advertised on March 15th 2022 and last modified on July 24th 2023."

Answered by AI

How many participants have signed up to take part in this experiment?

"Affirmative. Clinicaltrials.gov records indicate that this investigation, which was originally posted on March 15th 2022, is currently recruiting participants. Approximately 68 patients are required from a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Impact of Cultural and Linguistic Backgrounds on Patient Care and Experience of Women With Gynecologic Malignancies

2022. "Impact of Cultural and Linguistic Backgrounds on Patient Care and Experience of Women With Gynecologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05971303.