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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 : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:
A cross-sectional prospective study of follow-up in gynecologic cancer patients after primary treatment

Condition or disease
Gynecologic Cancer

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.


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Study Type : Observational
Estimated Enrollment : 1100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Health-related quality of life [ Time Frame: 15 months after first patient inclusion ]
    It will be evaluated using self-administered EORTC QLQ-C30 questionnaire

  2. 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)

  3. 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

  4. Health-related quality of life [ Time Frame: 15 months after first patient inclusion ]
    It will be evaluated using self-administered EORTC Sexual Health Questionnaire

  5. Health-related quality of life [ Time Frame: 15 months after first patient inclusion ]
    It will be evaluated using self-administered Distress Thermometer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Gynecologic cancer patients after primary treatment attending participating hospitals for routine follow-up.
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.

Information from the National Library of Medicine

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


Contacts
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Contact: EORTC HQ +32 2 774 1611 1514@eortc.org

Locations
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Austria
Medical University of Graz Recruiting
Graz, Austria, 8036
Contact: Eva Greimel         
Jordan
King Hussein Cancer Center Recruiting
Amman, Jordan, 11941
Contact: Abdulmajeed Dayyat, MD         
Netherlands
Radboudumc - Radboud University Medical Center Nijmegen Recruiting
Nijmegen, Netherlands, NL 6525
Contact: Petronella Beatrix Ottevanger         
UMC-Academisch Ziekenhuis Utrecht Recruiting
Utrecht, Netherlands, NL 3584 CX
Contact: Eleonora van Dorst         
Poland
Medical University Of Gdansk Recruiting
Gdansk, Poland, PL 80 211
Contact: Dagmara Klasa-Mazurkiewicz         
Spain
Hospital Universitario San Carlos Recruiting
Madrid, Spain
Contact: Antonio Casado         
Complejo Hospitalario de Navarra Recruiting
Pamplona, Spain
Contact: Ana Elena Villafranca Iturre         
United Kingdom
East Kent Hospitals University NHS Foundation Trust - Queen Elizabeth The Queen Mother Hospita Recruiting
Margate, Kent, United Kingdom, CT9 4AN
Contact: Andrew Nordin         
Northampton General Hospital NHS Trust Recruiting
Cliftonville, Northampton, United Kingdom, NN1 5BD
Contact: Roshan Agarwal         
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC

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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT03515993     History of Changes
Other Study ID Numbers: EORTC-1514-QLG-GCG
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
long-term survival
gynecologic cancer
quality of life