Questionnaire for Gynecologic Cancers

(iCALD-2 Trial)

Overseen By Crystal Wang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Inability to complete questionnaire

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the experiences and challenges faced by patients with gynecologic cancers, as well as interpreters and cancer care professionals working with them. Participants will complete questionnaires, including a Pictorial Educational Tool and Verbal Counseling Tool, to share their perspectives on treatment, communication, and barriers to care. The trial seeks patients treated for gynecologic cancer who prefer a language other than English, interpreters with medical experience, and cancer care professionals who work with culturally and linguistically diverse patients. As an unphased trial, this study offers participants the opportunity to contribute to improving communication and care for diverse patient populations.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on completing questionnaires rather than changing treatments.

What prior data suggests that this questionnaire is safe for participants?

Research has shown that questionnaires used in clinical studies are generally very safe. They involve only answering questions on paper or a computer, with no physical treatment or medication, so there are no side effects or health risks.

In this study, participants will complete questionnaires about their experiences and feelings. These are designed to help improve care for patients with gynecologic cancers. As it is just a survey, participants can be assured that there are no health risks involved in taking part.

Why are researchers excited about this trial?

Researchers are excited about this trial because it seeks to enhance the understanding and experience of culturally and linguistically diverse (CALD) patients with gynecologic cancers. Unlike standard treatments that focus solely on medical interventions, this approach uses detailed questionnaires to gather insights from patients, interpreters, and cancer care professionals. By identifying barriers and areas for improvement in communication and care delivery, this trial aims to optimize patient experiences and outcomes. This comprehensive feedback loop is unique and could lead to more personalized and effective care strategies for CALD patients.

What evidence suggests that this questionnaire is effective for understanding barriers in gynecologic cancer care?

This study does not test a medical treatment. Instead, it uses separate questionnaires to gather information from different groups. The "Patient Questionnaire" arm focuses on understanding the experiences of patients with gynecologic cancers. Meanwhile, the "Interpreter Questionnaire" and "Cancer Care Professional Questionnaire" arms gather insights from interpreters and cancer care professionals, respectively. The goal is to explore how cultural and language differences might affect care. By collecting this information, researchers aim to identify any barriers to optimal patient care. No data on treatment effectiveness exists because this study does not involve a medical intervention.

Who Is on the Research Team?

Stephanie L'Heureux

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

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.

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 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Questionnaire Administration

Eligible patients, interpreters, and cancer care professionals complete questionnaires in their specified preferred language or in English.

4 to 6 weeks

Administered in an outpatient setting

Follow-up

Participants are monitored for any additional insights or feedback post-questionnaire completion.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Questionnaire

Trial Overview 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.

How Is the Trial Designed?

Group I: Patient Questionnaire Experimental Treatment 1 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 Questionnaire Experimental Treatment 1 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 Questionnaire Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

The study developed an Adverse-Event Coping Scale (AECS) based on responses from 140 patients, demonstrating good reliability (coefficient of 0.82) and a one-dimensional structure with 11 items.

Higher AECS scores indicate that patients are facing serious adverse drug events (ADEs) and are making significant efforts to cope, which can help clinicians identify when timely interventions are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an adverse-event coping scale (AECS) using item response theory. Park, T., Hadsall, RS., Schommer, JC., et al.[2015]

The Society of Gynecologic Oncologists developed a comprehensive outcomes measure for endometrial cancer treatment, incorporating patient-reported data and assessments over a 120-day postoperative period, based on a study of 297 patients.

The tool aims to establish benchmarks for quality of care, showing that a high percentage of patients maintained independence post-surgery and reported high satisfaction scores, indicating effective treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Society of Gynecologic Oncologists Outcomes Task Force. Study of endometrical cancer: initial experiences. Kennedy, AW., Austin, JM., Look, KY., et al.[2019]

The self-administered questionnaire developed for patients with gynecologic cancer proved to be an effective tool for assessing hereditary cancer risk, identifying significant genetic risks in 23% of ovarian cancer patients and 42.9% of endometrial cancer patients for Lynch syndrome.

Younger endometrial cancer patients with a genetic risk of Lynch syndrome were diagnosed at an earlier age (mean age 47.79) compared to those without this risk (mean age 57.91), highlighting the importance of family history in cancer risk assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical utility of a self-administered questionnaire for assessment of hereditary gynecologic cancer. Masuda, K., Hirasawa, A., Irie-Kunitomi, H., et al.[2022]

A new assignment for specialist oncology nurses on adverse drug reaction (ADR) reporting resulted in 97% of the 33 reported ADRs being well documented, demonstrating the nurses' capability in pharmacovigilance.

The majority of nurses found the assignment useful and reported that it increased their awareness of medication safety, with 84% stating it changed how they managed ADRs in their practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The adverse drug reaction reporting assignment for specialist oncology nurses: a preliminary evaluation of quality, relevance and educational value in a prospective cohort study. Schutte, T., van Eekeren, R., Richir, M., et al.[2019]

A new worksheet developed for pharmacists helps track and analyze adverse reaction patterns in patients undergoing gynecologic cancer chemotherapy, improving the monitoring process.

The use of this worksheet has been shown to facilitate the detection of individual adverse reactions and prevent further complications, enhancing the safety and individualization of chemotherapy treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Monitoring sheet covering long-term chemotherapy to predict individual adverse reaction patterns for patients with gynecologic chemotherapy]. Doi, C., Iihara, N., Kawazoe, H., et al.[2019]

In a study involving 37 men with metastatic prostate cancer, patient-reported symptoms using the QLQ-C30 questionnaire identified 55 symptoms that physicians did not report, highlighting a significant gap in symptom detection by clinicians.

Physician reporting of chemotherapy side effects showed low sensitivity (47%) and specificity (68%) compared to patient reports, indicating that relying solely on clinician assessments may overlook important adverse events experienced by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. Fromme, EK., Eilers, KM., Mori, M., et al.[2022]

A study involving 77 cancer patients (37 with gynaecological cancer and 40 with prostate cancer) found that both electronic and paper formats of patient-reported toxicity questionnaires yielded consistent and reliable results in measuring treatment-related side effects after radiotherapy.

Patients generally found both formats clear and easy to use, with nearly half having no preference, indicating that electronic data capture for reporting toxicity is feasible and acceptable in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of data capture for patient-reported toxicity following radiotherapy for prostate or cervical cancer. Farnell, DJ., Routledge, J., Hannon, R., et al.[2022]

Patients receiving written preoperative information reported higher satisfaction levels compared to those who received verbal information, indicating that written materials may enhance understanding and preparedness for surgery.

The study found that patients who received written information experienced less postoperative pain, shorter hospital stays, and required fewer pain medications, suggesting that written preoperative information can lead to better recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of giving patients verbal or written pre-operative information in gynecologic oncology surgery: a randomized study and the medical-legal point of view. Angioli, R., Plotti, F., Capriglione, S., et al.[2014]

Citations