Cervical Ca PROs in Clinical Practice
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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. |
ClinicalTrials.gov Identifier: NCT03048435 |
Recruitment Status :
Active, not recruiting
First Posted : February 9, 2017
Last Update Posted : August 17, 2020
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Condition or disease | Intervention/treatment |
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Cervical Cancer Radiation Therapy | Other: EORTC QLQ CX-24 Other: Physician Feedback Form |
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 |

Group/Cohort | Intervention/treatment |
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Cervical Cancer Patients
Adult, English-speaking cervical cancer patients, who have been treated with curative intent chemo-radiotherapy.
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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 |
Oncologist
Oncologists who treat cervix cancer, with at least one consenting patient enrolled in the study.
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Other: Physician Feedback Form
This Feedback form to be completed by oncologists who have had at least one consenting patient participating in this study. |
- Percentage of EORTC QLQ CX24 questionnaire completed [ Time Frame: 9 months ]Gather information on feasibility of administering questionnaire
- 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

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.
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 |
Patient Inclusion Criteria:
- Adult (> 18 years) English speaking patients
- Treated with curative intent with chemo-radiotherapy
- Seen in routine clinic follow-up within 5 years post completion of treatment
Patient Exclusion Criteria:
- Patients at their anticipated last clinic visit prior to cancer center discharge
- Patients unable to complete the EORTC QLQ CX-24 questionnaire due to inability to read or write.
- Non-English speaking patients
- 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:
- Oncologists who treat cervix cancer
- 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.

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 ClinicalTrials.gov identifier (NCT number): NCT03048435
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 |
Principal Investigator: | Jennifer Croke, MD | University Health Network--Princess Margaret Cancer Centre |
Responsible Party: | University Health Network, Toronto |
ClinicalTrials.gov 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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cervical Cancer Patient Reported Outcomes Radiation Therapy EORTC QLQ-CX24 Quality of Life |
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases |