Follow-up in Gynecological Cancer Survivors

Active, not recruiting

• Conditions: Gynecologic Cancer

• Registration Number: NCT03515993
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-03-30
• Study First Submitted QC: 2018-04-23
• Study First Posted: 2018-05-04
• Study Start: 2019-02-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-24
• Primary Completion: 2024-03-31
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 1100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health-related quality of life	15 months after first patient inclusion	It will be evaluated using self-administered Distress Thermometer

Trial Locations

Locations (21)

Medical University of Graz; 🇦🇹 Graz, Austria

ZNA Middelheim; 🇧🇪 Antwerpen, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

Centre Hospitalier Chretien (CHC) - CHC MontLegia; 🇧🇪 Liège, Belgium

ZNA Jan Palfijn; 🇧🇪 Merksem, Belgium

Universitaetsklinikum Schleswig-Holstein - Campus Kiel; 🇩🇪 Kiel, Germany

HELIOS Kliniken - Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke; 🇩🇪 Wuppertal, Germany

Ospedale San Gerardo; 🇮🇹 Monza, Italy

Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"; 🇮🇹 Napoli, Italy

Azienda Ospedaliera Ordine Mauriziano di Torino; 🇮🇹 Torino, Italy

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