search
Back to results

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

Primary Purpose

Epithelial Ovarian Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Gynecological consultation
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epithelial Ovarian Cancer focused on measuring ovarian cancer, quality of life, remission more than 3 years

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU
  • Institut Bergonie
  • Polyclinique Bordeaux Nord
  • CHU
  • Centre François Baclesse
  • Centre Hospitalier
  • CHU Grenoble
  • Centre Oscar Lambret
  • Centre Léon Bérard
  • Institut régional du cancer
  • Centre Antoine Lacassagne
  • Hôpital Cochin
  • Hôpital Européen Georges Pompidou
  • Institut Jean Godinot
  • Institut de Cancérologie de l'Ouest
  • GHPSO
  • Institut de cancérologie de Lorraine
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Gynecological consulation

Arm Description

Outcomes

Primary Outcome Measures

Physical sequelae measured by the functional and biological effects

Secondary Outcome Measures

Full Information

First Posted
December 11, 2014
Last Updated
February 9, 2017
Sponsor
Centre Francois Baclesse
Collaborators
Ligue contre le cancer, France, Fondation de France
search

1. Study Identification

Unique Protocol Identification Number
NCT02323568
Brief Title
Live After an Epithelial Ovarian Cancer: Multidisciplinary Assessment of Effects and Long-term Remission in Patients Needs.
Acronym
VIVROVAIRE 2
Official Title
Live After an Epithelial Ovarian Cancer: Multidisciplinary Assessment of Effects and Long-term Remission in Patients Needs.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
Collaborators
Ligue contre le cancer, France, Fondation de France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer
Keywords
ovarian cancer, quality of life, remission more than 3 years

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gynecological consulation
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Gynecological consultation
Primary Outcome Measure Information:
Title
Physical sequelae measured by the functional and biological effects
Time Frame
At inclusion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence JOLY, PhD
Organizational Affiliation
Centre François Baclesse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Polyclinique Bordeaux Nord
City
Bordeaux
ZIP/Postal Code
33077
Country
France
Facility Name
CHU
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Hospitalier
City
Cholet
Country
France
Facility Name
CHU Grenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Institut régional du cancer
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Institut Jean Godinot
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Institut de Cancérologie de l'Ouest
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
GHPSO
City
Senlis
ZIP/Postal Code
60309
Country
France
Facility Name
Institut de cancérologie de Lorraine
City
Vandoeuvre les Nancy
ZIP/Postal Code
54519
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs