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

Not Applicable

Active, not recruiting

• Conditions: Germ Cell Tumor; Sex Cord Stromal Tumor; Malignant Non-epithelial Ovarian Tumors
• Interventions: Other: Self-questionnaires of living conditions and quality of life; Diagnostic Test: Cardiac, pulmonary, auditory and biological assessment

• Registration Number: NCT03418844
• Lead Sponsor: Centre Francois Baclesse

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-15
• Study First Submitted QC: 2018-01-25
• Study First Posted: 2018-02-01
• Study Start: 2018-05-07
• Primary Completion: 2021-07-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 268

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interest group (patients treated with chemotherapy)	Self-questionnaires of living conditions and quality of life	Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment
Interest group (patients treated with chemotherapy)	Cardiac, pulmonary, auditory and biological assessment	Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment
Patient control group (patients not treated with chemotherapy)	Cardiac, pulmonary, auditory and biological assessment	Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment
Patient control group (patients not treated with chemotherapy)	Self-questionnaires of living conditions and quality of life	Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment
Healthy volunteers	Self-questionnaires of living conditions and quality of life	Healthy volunteers will complete several self-questionnaires on living conditions and quality of life.

Primary Outcome Measures

Name	Time	Method
The quality of life by questionnaires	2 years after surgery
The late sequelae of chemotherapy, particularly cardiovascular and pulmonary disorders, in adult patients in remission of a rare cancer of the ovary treated by surgery, supplemented or not by chemotherapy.	2 years after surgery
The chronic fatigue by questionnaires	2 years after surgery

Secondary Outcome Measures

Name	Time	Method
The symptoms of menopause by questionnaires	2 years after surgery
Theimpact of cancer and its treatments on the trajectory and professional situation by questionnaires(access to work, professional ambition, financial situation ...);	2 years after surgery
The fertility monitoring by questionnaires	2 years after surgery
The parental projects by age (≤ 45 years) by questionnaires	2 years after surgery

Trial Locations

Locations (19)

CHU Besançon Jean MINJOZ; 🇫🇷 Besançon, France

Centre Paul Papin; 🇫🇷 Angers, France

Institut Bergonié; 🇫🇷 Bordeaux, France

CH Fleyriat; 🇫🇷 Bourg-en-Bresse, France

Centre François Baclesse; 🇫🇷 Caen, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Centre Léon Berard; 🇫🇷 Lyon, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

Centre Catherine de Sienne; 🇫🇷 Nantes, France

Institut de Cancérologie de l'Ouest; 🇫🇷 Nantes, France

GH Cochin Broca Hôtel-Dieu; 🇫🇷 Paris, France

HEGP; 🇫🇷 Paris, France

Hôpital Diaconesses-Croix St Simon; 🇫🇷 Paris, France

CHU Poitiers; 🇫🇷 Poitiers, France

Institut Gustave Roussy; 🇫🇷 Paris, France

Institut Curie,; 🇫🇷 Paris, France

Institut Jean Godinot; 🇫🇷 Reims, France

Institut Rennais de Cancérologie; 🇫🇷 Rennes, France

CHRU Stasbourg Hôpital Civil; 🇫🇷 Strasbourg, France