Cost Utility of Radical Surgery in Ovarian Cancer

Study Overview
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Brief Summary
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The purpose of this study is to investigate the medico-economic impact of adherence to INCa (National Cancer Institute) guidelines in ovarian cancer surgery by assessment of outcome in cost per Quality Adjusted Life Years (QALY).

Detailed Description
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This is a prospective, multicenter, comparative and non-randomized study designed to investigate the medico-economic impact of adherence to INCa guidelines in ovarian cancer surgery by assessment of outcome in cost per Quality Adjusted Life Years (QALY). A cost-utility study will be performed. It will primarily aim to assess the Incremental Cost-Utility Ratio (ICUR) at 3 years of the two treatment strategies of ovarian cancer surgery: adherence to INCa quality indicators versus non-adherence to INCa quality indicators. Consecutive patients with stage IIIC and IV ovarian, tubal, and primary peritoneal malignancies will be recruited in different health care institutions, including comprehensive cancer centers, university hospitals and private hospitals. Evaluation of adherence to quality indicators will be assessed retrospectively (once patients have completed the treatment) by two independent experts. 200 patients will be included over a period of 2 years and will be followed for a 3 years period after treatment (every 4 months the first two years and then every 6 months).

Official Title
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Cost Utility of Radical Surgery in Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Other: Collection of additional data with questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Woman with age ≥ 18 years. 2. Newly diagnosed ovarian, tubal or peritoneal malignancies. 3. Epithelial histology. 4. Stage IIIC or IVA with extrapelvic carcinomatosis according to FIGO classification 2014. 5. Patients undergoing primary surgery or neoadjuvant chemotherapy. 6. Performance Status ≤ 2. 7. Patient affiliated to a Social Health Insurance in France. 8. Patient information and informed consent form signed prior to any study specific procedures. Exclusion Criteria: 1. Benign or borderline tumors. 2. Patients with extra-abdominal disease, except for pleural effusion with positive cytology. 3. Other malignancy diagnosed in the previous 5 years except skin cancer (other than melanoma). 4. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure. 5. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ovarian cancer<br>Patient undergoing primary surgery for a newly diagnosed ovarian, tubal or peritoneal malignancies; Stage IIIc or IVa with extrapelvic carcinomatosis according to the International Federation of Gynecology and Obstetrics classification 2014 | Other: Collection of additional data with questionnaires<br>* questionnaires for quality of life measurements: QLQC30; QLQ-OV28 questionnaires for medico-economic purposes: ADL (activities of daily living); IADL (instrumental activities of daily living); EQ-5D3L; absenteeism questionnaire. These questionnaires will be completed during the study time (5 or 6 times during the treatment, next every 4 months during the first two years and then every 6 months during the third year of follow-up).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-utility study | The primary endpoint is defined as cost per Quality-Adjusted Life Year (QALY) at 3 years. Patient utilities will be obtained from the EuroQoL 5D-3L questionnaire. | 5 years and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of institutions adherent to INCa quality indicators | The rate of institutions adherent to INCa quality indicators corresponds to the number of institutions adherent to INCa quality indicators among the total number of institutions. | 2 years and 6 months | 
| Rate of patients adherent to INCa quality indicators | The rate of patients adherent to INCa quality indicators corresponds to the number of patients adherent to INCa quality indicators among the total number of patients. | 2 years and 6 months | 
| Quality of life | The quality of life will be evaluated according to the QLQ-C30, QLQ-0V28 and the EQ-5D-3L questionnaires | 5 years and 6 months | 
| Budgetary impact on the health insurance budget of these INCa quality indicators on the care management of ovarian cancer patients | Budgetary impact on the health insurance budget of these INCa quality indicators on the care management of ovarian cancer patients using costs data collected from the French insurance databases, Medical Information Departments of each participating centers and from patients' questionnaires (treatment costs, other induced costs and avoided costs). | 5 years and 6 months | 
| Progression Free Survival | Progression Free Survival is defined as the time from inclusion until progression or death from any cause | 5 years and 6 months | 
| Overall Survival | Overall Survival is defined as the time from inclusion until death from any cause or last follow-up news (censored data). | 5 years and 6 months | 
| Morbidity | Morbidity will be assessed through recording of adverse events using NCI-CTCAE toxicity classification and vital signs measurement. | 5 years and 6 months |