Follow-up in Gynecological Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT03515993|
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : June 17, 2019
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||1100 participants|
|Official Title:||Follow-up in Gynecological Cancer Survivors: An EORTC QLG-GCG Survivorship Study|
|Actual Study Start Date :||February 21, 2019|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
- Health-related quality of life [ Time Frame: 15 months after first patient inclusion ]It will be evaluated using self-administered EORTC QLQ-C30 questionnaire
- Health-related quality of life [ Time Frame: 15 months after first patient inclusion ]It will be evaluated using self-administered questions on anxiety (from the EORTC quality of life item library)
- Health-related quality of life [ Time Frame: 15 months after first patient inclusion ]It will be evaluated using self-administered EORTC OUT-PATSAT-C7 questionnaire
- Health-related quality of life [ Time Frame: 15 months after first patient inclusion ]It will be evaluated using self-administered EORTC Sexual Health Questionnaire
- Health-related quality of life [ Time Frame: 15 months after first patient inclusion ]It will be evaluated using self-administered Distress Thermometer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515993
|Contact: EORTC HQ||+32 2 774 firstname.lastname@example.org|
|Medical University of Graz||Recruiting|
|Graz, Austria, 8036|
|Contact: Eva Greimel|
|King Hussein Cancer Center||Recruiting|
|Amman, Jordan, 11941|
|Contact: Abdulmajeed Dayyat, MD|
|UMC-Academisch Ziekenhuis Utrecht||Recruiting|
|Utrecht, Netherlands, NL 3584 CX|
|Contact: Eleonora van Dorst|
|East Kent Hospitals University NHS Foundation Trust - Queen Elizabeth The Queen Mother Hospita||Recruiting|
|Margate, Kent, United Kingdom, CT9 4AN|
|Contact: Andrew Nordin|