Ovarian Cancer
Conditions
Brief summary
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
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).
Interventions
OTHERCollection of additional data with questionnaires
* 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).
Sponsors
Institut Claudius Regaud
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cost-utility study | 5 years and 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of institutions adherent to INCa quality indicators | 2 years and 6 months | 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. |
| Rate of patients "adherent" to INCa quality indicators | 2 years and 6 months | 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. |
| Quality of life | 5 years and 6 months | The quality of life will be evaluated according to the QLQ-C30, QLQ-0V28 and the EQ-5D-3L questionnaires |
| Budgetary impact on the health insurance budget of these INCa quality indicators on the care management of ovarian cancer patients | 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 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). |
| Progression Free Survival | 5 years and 6 months | Progression Free Survival is defined as the time from inclusion until progression or death from any cause |
| Overall Survival | 5 years and 6 months | Overall Survival is defined as the time from inclusion until death from any cause or last follow-up news (censored data). |
| Morbidity | 5 years and 6 months | Morbidity will be assessed through recording of adverse events using NCI-CTCAE toxicity classification and vital signs measurement. |
Countries
France
Outcome results
None listed