Live After an Epithelial Ovarian Cancer: Multidisciplinary Assessment of Effects and Long-term Remission in Patients Needs.
VIVROVAIRE 2
1 other identifier
interventional
179
1 country
18
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2014
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 11, 2014
CompletedFirst Posted
Study publicly available on registry
December 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedFebruary 10, 2017
September 1, 2015
1.6 years
December 11, 2014
February 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physical sequelae measured by the functional and biological effects
At inclusion
Study Arms (1)
Gynecological consulation
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Francois Baclesselead
- Ligue contre le cancer, Francecollaborator
- Fondation de Francecollaborator
Study Sites (18)
CHU
Besançon, 25030, France
Institut Bergonie
Bordeaux, 33076, France
Polyclinique Bordeaux Nord
Bordeaux, 33077, France
CHU
Caen, 14033, France
Centre François Baclesse
Caen, 14076, France
Centre Hospitalier
Cholet, France
CHU Grenoble
La Tronche, 38700, France
Centre Oscar Lambret
Lille, 59020, France
Centre Léon Bérard
Lyon, 69008, France
Institut régional du cancer
Montpellier, 34298, France
Centre Antoine Lacassagne
Nice, 06189, France
Hôpital Cochin
Paris, 75014, France
Hôpital Européen Georges Pompidou
Paris, 75015, France
Institut Jean Godinot
Reims, 51100, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805, France
GHPSO
Senlis, 60309, France
Institut de cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519, France
Institut Gustave Roussy
Villejuif, 94805, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Florence JOLY, PhD
Centre François Baclesse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2014
First Posted
December 23, 2014
Study Start
December 1, 2014
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
February 10, 2017
Record last verified: 2015-09