Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy (VIVROVAIRE TR)
Primary Purpose
Germ Cell Tumor, Sex Cord Stromal Tumor, Malignant Non-epithelial Ovarian Tumors
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Self-questionnaires of living conditions and quality of life
Cardiac, pulmonary, auditory and biological assessment
Sponsored by
About this trial
This is an interventional other trial for Germ Cell Tumor
Eligibility Criteria
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.
Sites / Locations
- Centre Paul Papin
- CHU Besançon Jean MINJOZ
- Institut Bergonié
- CH Fleyriat
- Centre François Baclesse
- Centre Jean Perrin
- Centre Léon Berard
- Institut Paoli Calmettes
- Centre Catherine de Sienne
- Institut de Cancérologie de l'Ouest
- GH Cochin Broca Hôtel-Dieu
- HEGP
- Hôpital Diaconesses-Croix St Simon
- Institut Curie,
- Institut Gustave Roussy
- CHU Poitiers
- Institut Jean Godinot
- Institut Rennais de Cancérologie
- CHRU Stasbourg Hôpital Civil
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Interest group (patients treated with chemotherapy)
Patient control group (patients not treated with chemotherapy)
Healthy volunteers
Arm 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
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 will complete several self-questionnaires on living conditions and quality of life.
Outcomes
Primary Outcome Measures
The chronic fatigue by questionnaires
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.
The quality of life by questionnaires
Secondary Outcome Measures
The fertility monitoring by questionnaires
The symptoms of menopause by questionnaires
Theimpact of cancer and its treatments on the trajectory and professional situation by questionnaires(access to work, professional ambition, financial situation ...);
The parental projects by age (≤ 45 years) by questionnaires
Full Information
NCT ID
NCT03418844
First Posted
January 15, 2018
Last Updated
July 31, 2023
Sponsor
Centre Francois Baclesse
Collaborators
ARCAGY/ GINECO GROUP
1. Study Identification
Unique Protocol Identification Number
NCT03418844
Brief Title
Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy
Acronym
VIVROVAIRE TR
Official Title
Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 7, 2018 (Actual)
Primary Completion Date
July 13, 2021 (Actual)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
Collaborators
ARCAGY/ GINECO GROUP
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Germ Cell Tumor, Sex Cord Stromal Tumor, Malignant Non-epithelial Ovarian Tumors
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients and healthy volunteers will complete several self-questionnaires on living conditions and quality of life. Patients will also perform a cardiac, pulmonary, auditory and biological assessment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
268 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interest group (patients treated with chemotherapy)
Arm Type
Other
Arm 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
Arm Title
Patient control group (patients not treated with chemotherapy)
Arm Type
Other
Arm 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
Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
Healthy volunteers will complete several self-questionnaires on living conditions and quality of life.
Intervention Type
Other
Intervention Name(s)
Self-questionnaires of living conditions and quality of life
Intervention Description
Patients will complete self-questionnaires of living conditions and quality of life (MFI-20, FACT-G/FACT-O, FACT/COG-NTX, FACT-Cog, HADS, Insomnia Severity Index , International Physical Activity Questionnaire)
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiac, pulmonary, auditory and biological assessment
Intervention Description
Patients will perform :
Cardiac assesments (ECG, Carotid and humeral Doppler ultrasound, Trans-thoracic echocardiography 2D and 3D)
Pulmonary and auditory assesment ( Respiratory Functional Exploration, Tonal audiogram)
Blood tests
Primary Outcome Measure Information:
Title
The chronic fatigue by questionnaires
Time Frame
2 years after surgery
Title
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.
Time Frame
2 years after surgery
Title
The quality of life by questionnaires
Time Frame
2 years after surgery
Secondary Outcome Measure Information:
Title
The fertility monitoring by questionnaires
Time Frame
2 years after surgery
Title
The symptoms of menopause by questionnaires
Time Frame
2 years after surgery
Title
Theimpact of cancer and its treatments on the trajectory and professional situation by questionnaires(access to work, professional ambition, financial situation ...);
Time Frame
2 years after surgery
Title
The parental projects by age (≤ 45 years) by questionnaires
Time Frame
2 years after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence JOLY
Organizational Affiliation
Centre François Baclesse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Paul Papin
City
Angers
Country
France
Facility Name
CHU Besançon Jean MINJOZ
City
Besançon
Country
France
Facility Name
Institut Bergonié
City
Bordeaux
Country
France
Facility Name
CH Fleyriat
City
Bourg-en-Bresse
Country
France
Facility Name
Centre François Baclesse
City
Caen
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
Country
France
Facility Name
Centre Léon Berard
City
Lyon
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
Country
France
Facility Name
Centre Catherine de Sienne
City
Nantes
Country
France
Facility Name
Institut de Cancérologie de l'Ouest
City
Nantes
Country
France
Facility Name
GH Cochin Broca Hôtel-Dieu
City
Paris
Country
France
Facility Name
HEGP
City
Paris
Country
France
Facility Name
Hôpital Diaconesses-Croix St Simon
City
Paris
Country
France
Facility Name
Institut Curie,
City
Paris
Country
France
Facility Name
Institut Gustave Roussy
City
Paris
Country
France
Facility Name
CHU Poitiers
City
Poitiers
Country
France
Facility Name
Institut Jean Godinot
City
Reims
Country
France
Facility Name
Institut Rennais de Cancérologie
City
Rennes
Country
France
Facility Name
CHRU Stasbourg Hôpital Civil
City
Strasbourg
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy
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