Cervical Ca PROs in Clinical Practice

Completed

• Conditions: Radiation Therapy; Cervical Cancer
• Interventions: Other: EORTC QLQ CX-24; Other: Physician Feedback Form

• Registration Number: NCT03048435
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-09
• Study Start: 2017-02-27
• Primary Completion: 2020-05-25
• Study Completion: 2020-05-25
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-01
• Last Update Posted: 2021-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cervical Cancer Patients	EORTC QLQ CX-24	Adult, English-speaking cervical cancer patients, who have been treated with curative intent chemo-radiotherapy.
Oncologist	Physician Feedback Form	Oncologists who treat cervix cancer, with at least one consenting patient enrolled in the study.

Primary Outcome Measures

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

Trial Locations

Locations (3)

Sunnybrook Research Institute; 🇨🇦 Toronto, Ontario, Canada

Royal Victoria Regional Health Centre; 🇨🇦 Barrie, Ontario, Canada

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada