Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02323568
Acronym
VIVROVAIRE 2
Enrollment
179
Registered
2014-12-23
Start date
2014-12-31
Completion date
2016-07-31
Last updated
2017-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epithelial Ovarian Cancer

Keywords

ovarian cancer, quality of life, remission more than 3 years

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

Interventions

OTHERGynecological consultation

Sponsors

Ligue contre le cancer, France
CollaboratorOTHER
Fondation de France
CollaboratorOTHER
Centre Francois Baclesse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Physical sequelae measured by the functional and biological effectsAt inclusion

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026