Live After an Epithelial Ovarian Cancer: Multidisciplinary Assessment of Effects and Long-term Remission in Patients Needs. (VIVROVAIRE 2)

February 9, 2017 updated by: Centre Francois Baclesse

This project is part of a large multicenter multidisciplinary program that will thoroughly explore the needs and difficulties of patients with BCR as well as those involved in their care. The results of this research program will propose recommendations for better structure and understand the follow up of these patients.

From the limited data in the literature, the long-term remission in patients with ovarian cancer reported a significant and persistent fatigue, poor QoL, disorders of sexuality as well as somatic and mental illness; consumption is also a medical records for these patients.

In this context, our team has initiated a large case-control study to assess fatigue (identified major problem in the long-term remission in patients with ovarian cancer), QoL and rehabilitation of patients in remission from an epithelial ovarian cancer (regardless of the stage of cancer at diagnosis, early or advanced) 3 years after the initial treatment, compared with women of the same age without ovarian cancer or serious chronic disease , from the general population.

Patients and controls complement standardized and validated self-administered questionnaire (part 1). This study investigated 215 patients in long remission from ovarian cancer compared to 215 women of the same age without cancer. Recruitment of patients is currently underway, in close collaboration with teams from the Group GINECO very involved in this project.

Following this step, an additional component is planned: it is to offer patients who participated in part 1, a specific gynecological consultation to assess in detail the effects of the treatments in order to better meet the needs of patients .dropoff window

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

179

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25030
        • CHU
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Bordeaux, France, 33077
        • Polyclinique Bordeaux Nord
      • Caen, France, 14076
        • Centre Francois Baclesse
      • Caen, France, 14033
        • CHU
      • Cholet, France
        • Centre Hospitalier
      • La Tronche, France, 38700
        • CHU Grenoble
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lyon, France, 69008
        • Centre Léon Bérard
      • Montpellier, France, 34298
        • Institut Régional du Cancer
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Paris, France, 75015
        • Hopital Europeen Georges Pompidou
      • Paris, France, 75014
        • Hopital Cochin
      • Reims, France, 51100
        • Institut Jean Godinot
      • Saint Herblain, France, 44805
        • Institut de Cancérologie de l'Ouest
      • Senlis, France, 60309
        • GHPSO
      • Vandoeuvre les Nancy, France, 54519
        • Institut de Cancerologie de Lorraine
      • Villejuif, France, 94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age> 18 years;
  • Patients who received optimal treatment (surgery, chemotherapy ...)
  • Patients with epithelial ovarian cancer after first-line treatment;
  • Patients without other cancer (except basal cell skin carcinoma and breast cancer in situ);
  • Patients without clinical relapse, biological or radiological documented at least 3 years after the initial treatment (from the end date of first line chemotherapy);
  • The interviews treatments are not recognized in the period;
  • Patients may be included regardless of the stage of cancer at diagnosis (early or late)
  • Patients who have signed their written consent to participate in the part 2 of the study Vivrovaire;
  • Patients who participated in part 1 of Vivrovaire study.

Exclusion Criteria:

  • Psychiatric pathology can disrupt the conduct of the study or to prevent the interpretation of results;
  • Persons deprived of liberty;
  • Major subject to a measure of legal protection or unable to consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Gynecological consulation
Other: Gynecological consultation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Physical sequelae measured by the functional and biological effects
Time Frame: At inclusion
At inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Collaborators

Ligue contre le cancer, France
Fondation de France

Investigators

  • Principal Investigator: Florence JOLY, PhD, Centre Francois Baclesse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

December 11, 2014

First Submitted That Met QC Criteria

December 18, 2014

First Posted (Estimate)

December 23, 2014

Study Record Updates

Last Update Posted (Actual)

February 10, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIVROVAIRE 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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