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

Not Applicable

Completed

• Conditions: Epithelial Ovarian Cancer
• Interventions: Other: Gynecological consultation

• Registration Number: NCT02323568
• Lead Sponsor: Centre Francois Baclesse

Brief Summary

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

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-18
• Study First Posted: 2014-12-23
• Status Verified: 2015-09
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 179

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gynecological consulation	Gynecological consultation	-

Primary Outcome Measures

Name	Time	Method
Physical sequelae measured by the functional and biological effects	At inclusion

Trial Locations

Locations (17)

Hôpital Cochin; 🇫🇷 Paris, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

GHPSO; 🇫🇷 Senlis, France

Polyclinique Bordeaux Nord; 🇫🇷 Bordeaux, France

Institut Jean Godinot; 🇫🇷 Reims, France

Institut de cancérologie de Lorraine; 🇫🇷 Vandoeuvre les Nancy, France

Centre Hospitalier; 🇫🇷 Cholet, France

Institut de Cancérologie de l'Ouest; 🇫🇷 Saint Herblain, France

Institut Bergonie; 🇫🇷 Bordeaux, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Centre François Baclesse; 🇫🇷 Caen, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Institut régional du cancer; 🇫🇷 Montpellier, France

CHU; 🇫🇷 Caen, France

CHU Grenoble; 🇫🇷 La Tronche, France

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

Centre Léon Bérard; 🇫🇷 Lyon, France