Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Follow-up in Gynecological Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date March 30, 2018
First Posted Date May 4, 2018
Last Update Posted Date November 8, 2019
Actual Study Start Date February 21, 2019
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2018)
  • 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03515993 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Follow-up in Gynecological Cancer Survivors
Official Title Follow-up in Gynecological Cancer Survivors: An EORTC QLG-GCG Survivorship Study
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Gynecologic cancer patients after primary treatment attending participating hospitals for routine follow-up.
Condition Gynecologic Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 23, 2018)
1100
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: EORTC HQ +32 2 774 1611 1514@eortc.org
Listed Location Countries Austria,   Jordan,   Netherlands,   Poland,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03515993
Other Study ID Numbers EORTC-1514-QLG-GCG
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Collaborators Not Provided
Investigators Not Provided
PRS Account European Organisation for Research and Treatment of Cancer - EORTC
Verification Date November 2019