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Cervical Ca PROs in Clinical Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03048435
Recruitment Status : Active, not recruiting
First Posted : February 9, 2017
Last Update Posted : August 17, 2020
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment
Cervical Cancer Radiation Therapy Other: EORTC QLQ CX-24 Other: Physician Feedback Form

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility and Acceptability of Measuring Cervical Cancer Specific Patient-Reported Outcomes in Clinical Practice
Actual Study Start Date : February 27, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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 Name: Quality of Life questionnaire

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.

Primary Outcome Measures :
  1. Percentage of EORTC QLQ CX24 questionnaire completed [ Time Frame: 9 months ]
    Gather information on feasibility of administering questionnaire

  2. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03048435

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Canada, Ontario
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada, L4M 6M2
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Jennifer Croke, MD University Health Network--Princess Margaret Cancer Centre
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Responsible Party: University Health Network, Toronto Identifier: NCT03048435    
Other Study ID Numbers: OCREB 16-055
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
Cervical Cancer
Patient Reported Outcomes
Radiation Therapy
Quality of Life
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases