Follow-up in Gynecological Cancer Survivors

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03515993
• Other study ID #: EORTC-1514-QLG-GCG
• Status: Active, not recruiting
• Start date: February 21, 2019
• Est. completion date: April 30, 2024

Study information

• Verified date: January 2024
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1100
• Est. completion date: April 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gynecologic Cancer

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Italy,  Jordan,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

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