Follow-up in Gynecological Cancer Survivors

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03515993

Enrollment

1100

Registered

2018-05-04

Start date

2019-02-21

Completion date

2026-08-31

Last updated

2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Cancer

Keywords

long-term survival, gynecologic cancer, quality of life

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Health-related quality of life	15 months after first patient inclusion	It will be evaluated using self-administered EORTC QLQ-C30 questionnaire

Countries

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

Outcome results