Clinical trial NCT03048435: Cervical Ca PROs in Clinical Practice
Official title: Feasibility and Acceptability of Measuring Cervical Cancer Specific Patient-Reported Outcomes in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Radiation Therapy
Keywords: Cervical Cancer
Patient Reported Outcomes
Radiation Therapy
EORTC QLQ-CX24
Quality of Life
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of EORTC QLQ CX24 questionnaire completed
timeFrame: 9 months
measure: Percentage of favorable scores (Agree or strongly agree) on Feedback Form
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: The Princess Margaret Cancer Foundation
name: Jennifer Croke, MD
role: PRINCIPAL_INVESTIGATOR
References: