Cervical Ca PROs in Clinical Practice

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03048435
• Other study ID #: OCREB 16-055
• Status: Completed
• Start date: February 27, 2017
• Est. completion date: May 25, 2020

Study information

• Verified date: October 2021
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 25, 2020
• Est. primary completion date: May 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Radiation Therapy
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
Canada	Royal Victoria Regional Health Centre	Barrie	Ontario
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	Sunnybrook Research Institute	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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