Cervical Ca PROs in Clinical Practice

• ClinicalTrials.gov Identifier: NCT03048435
• Recruitment Status: Active, not recruiting
• First Posted: February 9, 2017
• Last Update Posted: April 25, 2019
• Sponsor: University Health Network, Toronto
• Information provided by (Responsible Party): University Health Network, Toronto

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

Study Design

• Study Type: Observational
• Estimated 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: February 27, 2017
• Estimated Primary Completion Date: November 2020
• Estimated Study Completion Date: November 2020

Groups and Cohorts

Group/Cohort	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 Name: 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 :

1. Percentage of EORTC QLQ CX24 questionnaire completed [ Time Frame: 9 months ]
   Gather information on feasibility of administering questionnaire
2. Percentage of favorable scores (Agree or strongly agree) on Feedback Form [ Time Frame: 9 months ]
   Gather information on acceptability of incorporating the questionnaire in routine follow-up

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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.

Contacts and Locations

Locations

Canada, Ontario

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada, L4M 6M2

Sunnybrook Research Institute

Toronto, Ontario, Canada, M4N 3M5

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Sponsors and Collaborators

University Health Network, Toronto

Investigators

• Principal Investigator: Jennifer Croke, MD; University Health Network--Princess Margaret Cancer Centre

More Information

• Responsible Party: University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT03048435
• Other Study ID Numbers: OCREB 16-055
• First Posted: February 9, 2017
• Last Update Posted: April 25, 2019
• Last Verified: April 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Health Network, Toronto:

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

Additional relevant MeSH terms:

Uterine Cervical Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female