Cervical Ca PROs in Clinical Practice

NCT ID: NCT03048435

Last Updated: 2021-10-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-27
• Study Completion Date: 2020-05-25

Brief Summary

Concurrent chemo-radiotherapy followed by intracavitary brachytherapy is standard of care for patients with locally advanced cervical cancer. Although curative, this treatment is challenging and leaves a significant proportion of women with severe toxicity, negatively impacting their quality of life. Although most recover over time, a proportion of women do not. Therefore, evaluation of quality of life becomes increasingly more important as cancer specific outcomes improve. One such method is through patient-reported outcomes (PROs), defined as "any report coming directly from the patient about a health condition and its treatment." This prospective multi-institutional study, involving the Princess Margaret (PM), Odette Regional Cancer Centre(ORCC) and Royal Victoria Regional Health Center (RVH), will assess to feasibility and acceptability of integrating a cervical cancer specific PRO measurement tool into clinical practice. Cervical cancer patients coming for follow-up appointments will be asked to complete the EORTC QLQ-CX24, a validated cervical cancer specific PRO questionnaire. At the end of the study period, Feedback Forms will be completed by participating patients and health care providers to obtain their perspectives regarding the feasibility and acceptability of incorporating the instrument into clinical practice. Future directions include designing an electronic platform and expanding its use in cervical cancer clinics provincially and nationally. The data collected should help identify disease-related symptoms, treatment-related toxicities, facilitate patient-physician communication, shared treatment planning and target intervention strategies.

Conditions

Cervical Cancer; Radiation Therapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cervical Cancer Patients

Adult, English-speaking cervical cancer patients, who have been treated with curative intent chemo-radiotherapy.

EORTC QLQ CX-24

Intervention Type: OTHER

Disease specific Patient Reported Outcome measurement tool developed by the European Organization for Research and Treatment of Cancer (EORTC). This questionnaire covers symptoms common to women with cervical cancer and captures the impact of disease and/or treatment on domains including: urologic and gastro-intestinal symptoms, sexual functioning and body image.

Oncologist

Oncologists who treat cervix cancer, with at least one consenting patient enrolled in the study.

Physician Feedback Form

Intervention Type: OTHER

This Feedback form to be completed by oncologists who have had at least one consenting patient participating in this study.

Interventions

EORTC QLQ CX-24

Disease specific Patient Reported Outcome measurement tool developed by the European Organization for Research and Treatment of Cancer (EORTC). This questionnaire covers symptoms common to women with cervical cancer and captures the impact of disease and/or treatment on domains including: urologic and gastro-intestinal symptoms, sexual functioning and body image.

Intervention Type: OTHER

Physician Feedback Form

This Feedback form to be completed by oncologists who have had at least one consenting patient participating in this study.

Intervention Type: OTHER

Other Intervention Names

Quality of Life questionnaire

Eligibility Criteria

Inclusion Criteria

1. Adult (> 18 years) English speaking patients

2. Treated with curative intent with chemo-radiotherapy

3. Seen in routine clinic follow-up within 5 years post completion of treatment

1. Oncologists who treat cervix cancer

2. Oncologists with at least one consenting patient enrolled in the study

Exclusion Criteria

1. Patients at their anticipated last clinic visit prior to cancer center discharge

2. Patients unable to complete the EORTC QLQ CX-24 questionnaire due to inability to read or write.

3. Non-English speaking patients

4. Patients of the principal investigator. The rationale for this is that patients of the principal investigator who complete the Feedback form may be biased and this may be reflected in the results.

1) Principal investigator listed on the protocol. The rationale for this is that oncologists who are also investigators on this study may have inherent bias in the study which may be reflected in the results of the Feedback form.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Croke, MD

Role: PRINCIPAL_INVESTIGATOR

The Princess Margaret Cancer Foundation

Locations

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

Sunnybrook Research Institute

Toronto, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

OCREB 16-055

Identifier Type: -

Identifier Source: org_study_id