Cervical Ca PROs in Clinical Practice

October 1, 2021 updated by: University Health Network, Toronto

Feasibility and Acceptability of Measuring Cervical Cancer Specific Patient-Reported Outcomes in Clinical Practice

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Royal Victoria Regional Health Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Research Institute
      • Toronto, Ontario, Canada
        • Princess Margaret Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cervical cancer patients seen in follow-up, up to 5-years post-treatment, at the Princess Margaret, Odette, and Royal Victoria Regional Health Center as well their treating Oncologists.

Description

Patient 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

Patient 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.

Oncologist Inclusion Criteria:

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

Oncologist Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cervical Cancer Patients
Adult, English-speaking cervical cancer patients, who have been treated with curative intent chemo-radiotherapy.
Other: 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.
Other Names:
  • Quality of Life questionnaire
Oncologist
Oncologists who treat cervix cancer, with at least one consenting patient enrolled in the study.
Other: Physician Feedback Form
This Feedback form to be completed by oncologists who have had at least one consenting patient participating in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of EORTC QLQ CX24 questionnaire completed
Time Frame: 9 months
Gather information on feasibility of administering questionnaire
9 months
Percentage of favorable scores (Agree or strongly agree) on Feedback Form
Time Frame: 9 months
Gather information on acceptability of incorporating the questionnaire in routine follow-up
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Jennifer Croke, MD, The Princess Margaret Cancer Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2017

Primary Completion (Actual)

May 25, 2020

Study Completion (Actual)

May 25, 2020

Study Registration Dates

First Submitted

February 7, 2017

First Submitted That Met QC Criteria

February 7, 2017

First Posted (Estimate)

February 9, 2017

Study Record Updates

Last Update Posted (Actual)

October 5, 2021

Last Update Submitted That Met QC Criteria

October 1, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCREB 16-055

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervical Cancer

Clinical Trials on EORTC QLQ CX-24

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe