Clinical trial NCT02323568: Live After an Epithelial Ovarian Cancer: Multidisciplinary Assessment of Effects and Long-term Remission in Patients Needs.
Official title: Live After an Epithelial Ovarian Cancer: Multidisciplinary Assessment of Effects and Long-term Remission in Patients Needs.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epithelial Ovarian Cancer
Keywords: ovarian cancer
quality of life
remission more than 3 years
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
Collaborators: name: Ligue contre le cancer, France
name: Fondation de France
First posted: 2014-12-23
Enrollment: 179
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: 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.

Primary outcomes:
measure: Physical sequelae measured by the functional and biological effects
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU
city: Bordeaux
country: France
facility: Institut Bergonie
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord
city: Caen
country: France
facility: CHU
city: Caen
country: France
facility: Centre François Baclesse
city: Cholet
country: France
facility: Centre Hospitalier
city: La Tronche
country: France
facility: CHU Grenoble
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Bérard
city: Montpellier
country: France
facility: Institut régional du cancer
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Reims
country: France
facility: Institut Jean Godinot
city: Saint Herblain
country: France
facility: Institut de Cancérologie de l'Ouest
city: Senlis
country: France
facility: GHPSO
city: Vandoeuvre les Nancy
country: France
facility: Institut de cancérologie de Lorraine
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Centre François Baclesse
name: Florence JOLY, PhD
role: PRINCIPAL_INVESTIGATOR
References: