Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 268
- Locations
- 38
- Primary Endpoint
- 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.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Interest group (patients treated with chemotherapy)
Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment
Intervention: Self-questionnaires of living conditions and quality of life (Other)
Interest group (patients treated with chemotherapy)
Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment
Intervention: Cardiac, pulmonary, auditory and biological assessment (Diagnostic Test)
Patient control group (patients not treated with chemotherapy)
Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment
Intervention: Self-questionnaires of living conditions and quality of life (Other)
Patient control group (patients not treated with chemotherapy)
Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment
Intervention: Cardiac, pulmonary, auditory and biological assessment (Diagnostic Test)
Healthy volunteers
Healthy volunteers will complete several self-questionnaires on living conditions and quality of life.
Intervention: Self-questionnaires of living conditions and quality of life (Other)
Outcomes
Primary Outcomes
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
The chronic fatigue by questionnaires
Time Frame: 2 years after surgery
The quality of life by questionnaires
Time Frame: 2 years after surgery
Secondary Outcomes
- The fertility monitoring by questionnaires(2 years after surgery)
- The parental projects by age (≤ 45 years) by questionnaires(2 years after surgery)
- 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)