Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy (VIVROVAIRE TR)

Centre Francois Baclesse

Status

Active, not recruiting

Conditions

Malignant Non-epithelial Ovarian Tumors

Germ Cell Tumor

Sex Cord Stromal Tumor

Treatments

Other: Self-questionnaires of living conditions and quality of life

Diagnostic Test: Cardiac, pulmonary, auditory and biological assessment

Study type

Interventional

Funder types

Other

Identifiers

NCT03418844

VIVROVAIRE TR

Details and patient eligibility

About

While they are documented in patients in remission of testicular cancer, the sequelae of chemotherapy and the impact of the disease and its treatments on the living conditions and QoL of women in remission of rare ovarian cancer remain poorly explored.

The coordinator therefore propose a national 2-step case-control study to evaluate 1) chronic fatigue and QoL and 2) chemotherapy-related sequelae in adult patients in remission of surgery-treated TGMO or TSCS (conservative or not) supplemented with chemotherapy

Enrollment

268 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age> 18 years;
Patient with an ovarian malignant germ cell tumor (TGMO) or a stroma tumor and / or sex cords (TSCS) treated optimally;
Patient who has had surgery and chemotherapy (interest group) or only a surgery (control group);
Patient in remission more than 2 years after the end of the initial treatment;
Relapse authorized if remission more than 2 years after the end of the treatment;
Patient with no other cancers (with the exception of basal cell skin carcinomas, in situ cancers of the breast and cervix);
Patient having signed his consent to participate

Exclusion criteria

Pregnant or breastfeeding woman;
Psychiatric pathology that may disrupt the course of the study or prevent the interpretation of results;
Person deprived of liberty;
Major subject to a legal protection measure or unable to express his consent.

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

268 participants in 3 patient groups

Interest group (patients treated with chemotherapy)

Other group

Description:

Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment

Treatment:

Diagnostic Test: Cardiac, pulmonary, auditory and biological assessment

Other: Self-questionnaires of living conditions and quality of life

Patient control group (patients not treated with chemotherapy)

Other group

Description:

Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment

Treatment:

Diagnostic Test: Cardiac, pulmonary, auditory and biological assessment

Other: Self-questionnaires of living conditions and quality of life

Healthy volunteers

Other group

Description:

Healthy volunteers will complete several self-questionnaires on living conditions and quality of life.

Treatment:

Other: Self-questionnaires of living conditions and quality of life