Overview

This trial is active, not recruiting.

Condition epithelial ovarian cancer
Treatment gynecological consultation
Sponsor Centre Francois Baclesse
Collaborator Ligue contre le cancer, France
Start date December 2014
End date July 2016
Trial size 179 participants
Trial identifier NCT02323568, VIVROVAIRE 2

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Other)
gynecological consultation

Primary Outcomes

Measure
Physical sequelae measured by the functional and biological effects
time frame: At inclusion

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title Live After an Epithelial Ovarian Cancer: Multidisciplinary Assessment of Effects and Long-term Remission in Patients Needs.
Principal investigator Florence JOLY, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Centre Francois Baclesse.