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

NCT ID: NCT02323568

Last Updated: 2017-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Epithelial Ovarian Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Gynecological consulation

Group Type OTHER

Gynecological consultation

Intervention Type OTHER

Interventions

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Gynecological consultation

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ligue contre le cancer, France

OTHER

Sponsor Role collaborator

Fondation de France

OTHER

Sponsor Role collaborator

Centre Francois Baclesse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florence JOLY, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre François Baclesse

Locations

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CHU

Besançon, , France

Site Status

Institut Bergonie

Bordeaux, , France

Site Status

Polyclinique Bordeaux Nord

Bordeaux, , France

Site Status

CHU

Caen, , France

Site Status

Centre François Baclesse

Caen, , France

Site Status

Centre Hospitalier

Cholet, , France

Site Status

CHU Grenoble

La Tronche, , France

Site Status

Centre Oscar Lambret

Lille, , France

Site Status

Centre Léon Bérard

Lyon, , France

Site Status

Institut régional du cancer

Montpellier, , France

Site Status

Centre Antoine Lacassagne

Nice, , France

Site Status

Hôpital Cochin

Paris, , France

Site Status

Hôpital Européen Georges Pompidou

Paris, , France

Site Status

Institut Jean Godinot

Reims, , France

Site Status

Institut de Cancérologie de l'Ouest

Saint-Herblain, , France

Site Status

GHPSO

Senlis, , France

Site Status

Institut de cancérologie de Lorraine

Vandœuvre-lès-Nancy, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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VIVROVAIRE 2

Identifier Type: -

Identifier Source: org_study_id

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