Cervical Ca PROs in Clinical Practice

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT03048435

Collaborator

(none)

100

Enrollment

Locations

38.9

Actual Duration (Months)

33.3

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Cervical Cancer Radiation Therapy	Other: EORTC QLQ CX-24 Other: Physician Feedback Form

Study Design

Study Type:

Observational

Actual 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 :

Feb 27, 2017

Actual Primary Completion Date :

May 25, 2020

Actual Study Completion Date :

May 25, 2020

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Victoria Regional Health Centre	Barrie	Ontario	Canada	L4M 6M2
2	Sunnybrook Research Institute	Toronto	Ontario	Canada	M4N 3M5
3	Princess Margaret Cancer Centre	Toronto	Ontario	Canada