Live After an Epithelial Ovarian Cancer: Multidisciplinary Assessment of Effects and Long-term Remission in Patients Needs.
NCT ID: NCT02323568
Last Updated: 2017-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
179 participants
INTERVENTIONAL
2014-12-31
2016-07-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Gynecological consulation
Gynecological consultation
Interventions
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Gynecological consultation
Eligibility Criteria
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Inclusion Criteria
* 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
* Persons deprived of liberty;
* Major subject to a measure of legal protection or unable to consent.
18 Years
FEMALE
No
Sponsors
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Ligue contre le cancer, France
OTHER
Fondation de France
OTHER
Centre Francois Baclesse
OTHER
Responsible Party
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Principal Investigators
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Florence JOLY, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre François Baclesse
Locations
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CHU
Besançon, , France
Institut Bergonie
Bordeaux, , France
Polyclinique Bordeaux Nord
Bordeaux, , France
CHU
Caen, , France
Centre François Baclesse
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
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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VIVROVAIRE 2
Identifier Type: -
Identifier Source: org_study_id
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