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

Epithelial Ovarian Cancer Clinical Trial

— VIVROVAIRE 2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02323568
• Other study ID #: VIVROVAIRE 2
• Status: Completed
• Phase: N/A
• First received: December 11, 2014
• Last updated: February 9, 2017
• Start date: December 2014
• Est. completion date: July 2016

Study information

• Verified date: September 2015
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epithelial Ovarian Cancer
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms

Intervention

Other:
• Gynecological consultation

Locations

Country	Name	City	State
France	CHU	Besançon
France	Institut Bergonie	Bordeaux
France	Polyclinique Bordeaux Nord	Bordeaux
France	Centre François Baclesse	Caen
France	CHU	Caen
France	Centre Hospitalier	Cholet
France	CHU Grenoble	La Tronche
France	Centre Oscar Lambret	Lille
France	Centre Léon Bérard	Lyon
France	Institut régional du cancer	Montpellier
France	Centre Antoine Lacassagne	Nice
France	Hôpital Cochin	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Institut Jean Godinot	Reims
France	Institut de Cancérologie de l'Ouest	Saint Herblain
France	GHPSO	Senlis
France	Institut de cancérologie de Lorraine	Vandoeuvre les Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (3)

Lead Sponsor	Collaborator
Centre Francois Baclesse	Fondation de France, Ligue contre le cancer, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical sequelae measured by the functional and biological effects		At inclusion