A cross-sectional prospective study of follow-up in gynecologic cancer patients after primary treatment
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
Health-related quality of life — 15 months after first patient inclusion It will be evaluated using self-administered EORTC QLQ-C30 questionnaire
Health-related quality of life — 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 — 15 months after first patient inclusion It will be evaluated using self-administered EORTC OUT-PATSAT-C7 questionnaire
Health-related quality of life — 15 months after first patient inclusion It will be evaluated using self-administered EORTC Sexual Health Questionnaire
Health-related quality of life — 15 months after first patient inclusion It will be evaluated using self-administered Distress Thermometer
Trial sites (21)
Facility
City
Region
Status
Medical University of Graz
Graz
Austria
ZNA Middelheim
Antwerp
Belgium
Universitair Ziekenhuis Gent
Ghent
Belgium
Centre Hospitalier Chretien (CHC) - CHC MontLegia
Liège
Belgium
ZNA Jan Palfijn
Merksem
Belgium
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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