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Cervical CancerNCT03048435

Cervical Ca PROs in Clinical Practice

An observational study of Cervical Cancer and Radiation Therapy, run by University Health Network, Toronto at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cervical Cancer, Radiation Therapy
What is being tested?
EORTC QLQ CX-24 and Physician Feedback Form
How many people
100 participants
Where
3 sitesCanada
Study dates
27 Feb 2017to 25 May 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

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.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre

    Toronto, Ontario

Other trials in Canada

About this study

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

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.

Being tested
EORTC QLQ CX-24, Physician Feedback Form
Keywords
Cervical Cancer, Patient Reported Outcomes, Radiation Therapy, EORTC QLQ-CX24, Quality of Life
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EORTC QLQ CX-24Other

    Also called Quality of Life questionnaire

    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.

  • Physician Feedback FormOther

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

Study groups in NCT03048435
Study groupRoleWhat they receive
Cervical Cancer PatientsAdult, English-speaking cervical cancer patients, who have been treated with curative intent chemo-radiotherapy.
Receives: Other: EORTC QLQ CX-24
OncologistOncologists who treat cervix cancer, with at least one consenting patient enrolled in the study.
Receives: Other: Physician Feedback Form

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of EORTC QLQ CX24 questionnaire completed

    Gather information on feasibility of administering questionnaire

    Measured: 9 months

  2. Percentage of favorable scores (Agree or strongly agree) on Feedback Form

    Gather information on acceptability of incorporating the questionnaire in routine follow-up

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2017 (estimated)
  2. Study start27 Feb 2017
  3. Primary completion25 May 2020
  4. Study completion25 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03048435
Sponsor's protocol ID
OCREB 16-055
Status last verified
Oct 2021
First submitted
7 Feb 2017
Last updated
5 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Cancer and Radiation Therapy, run by University Health Network, Toronto at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of EORTC QLQ CX24 questionnaire completed (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03048435.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.

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