Follow-up in Gynecological Cancer Survivors

May 7, 2026 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Follow-up in Gynecological Cancer Survivors: An EORTC QLG-GCG Survivorship Study

A cross-sectional prospective study of follow-up in gynecologic cancer patients after primary treatment

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

The objective of this study is to identify physical and psychosocial problems and needs after treatment for gynecological cancer.

1100 patients stratified by cancer sites and treatment - a minimum of 120 patients within each stratum - will be recruited.

Institutional data on follow-up policy, demographic and clinical data (related to treatment history and tumor characteristics) will be collected. Patients will complete a set of 76 Quality of Life questions, at one single time point.

Descriptive analyses will be conducted to characterize the collected data. Multivariate model building will be used to identify patterns of physical, psychological and social problems based on factors specific to the patient and to the disease. Logistic multinomial or continuous regression analysis will be used to investigate which socio-demographic, clinical variables, or institutional are associated significantly with compromised quality of life and sexual health outcomes. Exploratory factor analysis will be used to explore the factor structure of the various PROMs to identify issue clustering.

Study Type

Observational

Enrollment (Estimated)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medical University of Graz
  • Belgium
      • Antwerp, Belgium
        • ZNA Middelheim
      • Ghent, Belgium
        • Universitair Ziekenhuis Gent
      • Liège, Belgium
        • Centre Hospitalier Chretien (CHC) - CHC MontLegia
      • Merksem, Belgium
        • ZNA Jan Palfijn
  • Germany
      • Kiel, Germany
        • Universitaetsklinikum Schleswig-Holstein - Campus Kiel
      • Wuppertal, Germany
        • HELIOS Kliniken - Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke
  • Italy
      • Monza, Italy
        • Ospedale San Gerardo
      • Naples, Italy
        • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
      • Torino, Italy
        • Azienda Ospedaliera Ordine Mauriziano di Torino
  • Jordan
      • Amman, Jordan, 11941
        • King Hussein Cancer Center
  • Netherlands
      • Nijmegen, Netherlands, NL 6525
        • Radboudumc - Radboud University Medical Center Nijmegen
      • Utrecht, Netherlands, NL 3584 CX
        • UMC-Academisch Ziekenhuis Utrecht
  • Poland
      • Gdansk, Poland, PL 80 211
        • Medical University of Gdansk
  • Spain
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Hospital Universitario San Carlos
      • Pamplona, Spain
        • Complejo Hospitalario de Navarra
      • Salamanca, Spain
        • Hospital Universitario de Salamanca
  • United Kingdom
      • Glasgow, United Kingdom
        • NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital
    • Kent
      • Margate, Kent, United Kingdom, CT9 4AN
        • East Kent Hospitals University NHS Foundation Trust - Queen Elizabeth The Queen Mother Hospita
    • Northampton
      • Cliftonville, Northampton, United Kingdom, NN1 5BD
        • Northampton General Hospital NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Gynecologic cancer patients after primary treatment attending participating hospitals for routine follow-up.

Description

Inclusion Criteria:

  • Histological proven gynecological cancer (cervical, endometrial, ovarian (including fallopian tube and peritoneal primary), vulva).
  • FIGO stage I-IV before completion of primary therapy.
  • Disease-free without any evidence of relapse: no symptoms or signs potentially indicating recurrent disease (assessed according to standard clinical parameters using physical and gynecological examination, blood tests, CA 125 (ovarian cancer), or radiological imaging techniques).
  • At least 6 months but no more than 5 years since completion of primary treatment.
  • Performance status 0, 1 or 2 (WHO scale).
  • Age ≥ 18 years.
  • Ability to understand and fill out questionnaires.
  • Written informed consent according to ICH/GCP, and national/local regulations.

Exclusion Criteria:

  • Other cancer diagnosis in the past 5 years.
  • Patients participating in interventional clinical studies with Quality of Life as primary endpoint.
  • Any psychological (including pre-existing psychiatric disorders), familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life
Time Frame: 15 months after first patient inclusion
It will be evaluated using self-administered EORTC QLQ-C30 questionnaire
15 months after first patient inclusion
Health-related quality of life
Time Frame: 15 months after first patient inclusion
It will be evaluated using self-administered questions on anxiety (from the EORTC quality of life item library)
15 months after first patient inclusion
Health-related quality of life
Time Frame: 15 months after first patient inclusion
It will be evaluated using self-administered EORTC OUT-PATSAT-C7 questionnaire
15 months after first patient inclusion
Health-related quality of life
Time Frame: 15 months after first patient inclusion
It will be evaluated using self-administered EORTC Sexual Health Questionnaire
15 months after first patient inclusion
Health-related quality of life
Time Frame: 15 months after first patient inclusion
It will be evaluated using self-administered Distress Thermometer
15 months after first patient inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2019

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

March 30, 2018

First Submitted That Met QC Criteria

April 23, 2018

First Posted (Actual)

May 4, 2018

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EORTC-1514-QLG-GCG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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