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Cervical Ca PROs in Clinical Practice

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03048435
Enrollment
100
Registered
2017-02-09
Start date
2017-02-27
Completion date
2020-05-25
Last updated
2021-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Radiation Therapy

Keywords

Cervical Cancer, Patient Reported Outcomes, Radiation Therapy, EORTC QLQ-CX24, Quality of Life

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.

Interventions

OTHEREORTC 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.

OTHERPhysician Feedback Form

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

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of EORTC QLQ CX24 questionnaire completed9 monthsGather information on feasibility of administering questionnaire
Percentage of favorable scores (Agree or strongly agree) on Feedback Form9 monthsGather information on acceptability of incorporating the questionnaire in routine follow-up

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026