Cost Utility of Radical Surgery in Ovarian Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-18

Study Completion Date

2025-04-15

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).

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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).

Conditions

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Ovarian Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Ovarian cancer

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

Group Type OTHER

Collection of additional data with questionnaires

Intervention Type OTHER

* 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).

Interventions

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Collection 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).

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No