Clinical trial NCT03515993: Follow-up in Gynecological Cancer Survivors
Official title: Follow-up in Gynecological Cancer Survivors: An EORTC QLG-GCG Survivorship Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gynecologic Cancer
Keywords: long-term survival
gynecologic cancer
quality of life
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2018-05-04
Enrollment: 1100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gynecologic cancer patients after primary treatment attending participating hospitals for routine follow-up.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Health-related quality of life
timeFrame: 15 months after first patient inclusion
measure: Health-related quality of life
timeFrame: 15 months after first patient inclusion
measure: Health-related quality of life
timeFrame: 15 months after first patient inclusion
measure: Health-related quality of life
timeFrame: 15 months after first patient inclusion
measure: Health-related quality of life
timeFrame: 15 months after first patient inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Liège
country: Belgium
facility: Centre Hospitalier Chretien (CHC) - CHC MontLegia
city: Merksem
country: Belgium
facility: ZNA Jan Palfijn
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel
city: Wuppertal
country: Germany
facility: HELIOS Kliniken - Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke
city: Monza
country: Italy
facility: Ospedale San Gerardo
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
city: Torino
country: Italy
facility: Azienda Ospedaliera Ordine Mauriziano di Torino
city: Amman
country: Jordan
facility: King Hussein Cancer Center
city: Nijmegen
country: Netherlands
facility: Radboudumc - Radboud University Medical Center Nijmegen
city: Utrecht
country: Netherlands
facility: UMC-Academisch Ziekenhuis Utrecht
city: Gdansk
country: Poland
facility: Medical University Of Gdansk
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario San Carlos
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Margate
country: United Kingdom
facility: East Kent Hospitals University NHS Foundation Trust - Queen Elizabeth The Queen Mother Hospita
state: Kent
city: Cliftonville
country: United Kingdom
facility: Northampton General Hospital NHS Trust
state: Northampton
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital
Study officials:
References: