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

Study Overview
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Brief Summary
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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

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

Conditions
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Germ Cell Tumor, Sex Cord Stromal Tumor, Malignant Non-epithelial Ovarian Tumors

Intervention / Treatment
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* Other: Self-questionnaires of living conditions and quality of life
* Diagnostic Test: Cardiac, pulmonary, auditory and biological assessment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Interest group (patients treated with chemotherapy)<br>Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment | Other: Self-questionnaires of living conditions and quality of life<br>* 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)<br>Diagnostic Test: Cardiac, pulmonary, auditory and biological assessment<br>* 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<br>|
| Other: Patient control group (patients not treated with chemotherapy)<br>Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment | Other: Self-questionnaires of living conditions and quality of life<br>* 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)<br>Diagnostic Test: Cardiac, pulmonary, auditory and biological assessment<br>* 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<br>|
| Other: Healthy volunteers<br>Healthy volunteers will complete several self-questionnaires on living conditions and quality of life. | Other: Self-questionnaires of living conditions and quality of life<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The chronic fatigue 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 quality of life by questionnaires |  | 2 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The fertility monitoring 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 | 
| The parental projects by age (≤ 45 years) by questionnaires |  | 2 years after surgery |