NCT03515993

Follow-up in Gynecological Cancer Survivors

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,100 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gynecologic Cancer

Timeline

• Start date: 2019-02-21
• Primary completion: 2024-03-31
• Completion: 2024-04-30
• First posted: 2018-05-04
• Last updated: 2024-01-24

Locations

21 sites across 9 countries: Austria, Belgium, Germany, Italy, Jordan, Netherlands, Poland, Spain, United Kingdom