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

45 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Questionnaire, Pictorial Educational Tool, Verbal Counseling Tool for gynecologic cancers?

Research shows that using multimedia tools, like pictorial and verbal counseling, can improve patients' understanding and satisfaction with their treatment decisions, as seen in studies involving endometrial cancer patients. ^{1 2 3 4 5}

Is the Questionnaire for Gynecologic Cancers safe for humans?

The research indicates that questionnaires used to capture patient-reported toxicity following treatments like radiotherapy are reliable and easy to use, suggesting they are safe for patients to complete. These tools help in monitoring adverse reactions effectively, which can improve safety in treatment settings. ^{6 7 8 9 10}

How does this treatment differ from other treatments for gynecologic cancers?

This treatment involves a self-administered questionnaire that helps identify women at risk for hereditary gynecologic cancers, which is different from traditional treatments that focus on medical or surgical interventions. It is unique because it aids in early identification and referral for genetic counseling, potentially leading to earlier and more personalized care. ^{11 12 13 14 15}

Research Team

Stephanie L'Heureux

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A prospective study of the feasibility and acceptability of a Web-based, electronic patient-reported outcome system in assessing patient recovery after major gynecologic cancer surgery. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The health-related quality of life journey of gynecologic oncology surgical patients: Implications for the incorporation of patient-reported outcomes into surgical quality metrics. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A prospective randomized trial of standard versus multimedia-supplemented counseling in patients undergoing endometrial cancer staging surgery. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Society of Gynecologic Oncologists Outcomes Task Force. Study of endometrical cancer: initial experiences. [2019]

5. Ireland 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. [2014]

6. Japan pubmed.ncbi.nlm.nih.gov

[Monitoring sheet covering long-term chemotherapy to predict individual adverse reaction patterns for patients with gynecologic chemotherapy]. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy of data capture for patient-reported toxicity following radiotherapy for prostate or cervical cancer. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Development of an adverse-event coping scale (AECS) using item response theory. [2015]

9. United States 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. [2022]

10. Germany 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. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Clinical utility of a self-administered questionnaire for assessment of hereditary gynecologic cancer. [2022]

12. Poland pubmed.ncbi.nlm.nih.gov

Psychometric properties and cultural adaptation of Polish version of Gynecological Cancers Awareness Scale (GCAS). [2022]

13. United States pubmed.ncbi.nlm.nih.gov

A self-administered family history questionnaire improves identification of women who warrant referral to genetic counseling for hereditary cancer risk. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Development of a population survey concerning papanicolaou smear screening for cervical disease. [2019]

15. Netherlands pubmed.ncbi.nlm.nih.gov

Sexual health needs and educational intervention preferences for women with cancer. [2022]