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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ovarian cancer | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of additional data with questionnaires | Other |
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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonie | Bordeaux | 33076 | France | |||
| Chu Clermont Ferrand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33808284 | Background | Alejandra M, Gertych W, Pomel C, Ferron G, Lusque A, Angeles MA, Lambaudie E, Rouzier R, Bakrin N, Golfier F, Glehen O, Canis M, Bourdel N, Pouget N, Colombo PE, Guyon F, Meurette J, Querleu D. Adherence to French and ESGO Quality Indicators in Ovarian Cancer Surgery: An Ad-Hoc Analysis from the Prospective Multicentric CURSOC Study. Cancers (Basel). 2021 Mar 30;13(7):1593. doi: 10.3390/cancers13071593. | |
| 29608972 |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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|
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 |
| Clermont-Ferrand |
| 63003 |
| France |
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| Institut Paoli Calmettes | Marseille | France |
| Institut Regional Du Cancer Montpellier | Montpellier | 34298 | France |
| Institut Curie | Paris | 75248 | France |
| Centre Hospitalier Lyon Sud 1 | Pierre-Bénite | 69495 | France |
| Centre Hospitalier Lyon Sud 2 | Pierre-Bénite | 69495 | France |
| Institut Claudius Regaud | Toulouse | 31059 | France |
| Hopital Nord-Ouest - Villefranche Sur Saone | Villefranche-sur-Saône | 69655 | France |
| Derived |
| Filleron T, Lusque A, Dalenc F, Ferron G, Roche H, Martinez A, Jouve E. Alternative methodological approach to randomized trial for surgical procedures routinely used. Contemp Clin Trials. 2018 May;68:109-115. doi: 10.1016/j.cct.2018.03.016. Epub 2018 Mar 30. |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |