Economic Evaluation of Three Populational Screening Strategies for Cervical Cancer

NCT01373723UNKNOWNNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Enrollment

20994

Start Date

2010-09-01

Completion Date

2012-12-01

Study Type

INTERVENTIONAL

Official Title

Economic Evaluation of Three Populational Screening Strategies for Cervical Cancer in the County of Valles Occidental: CRICERVA Clinical Trial.

Interventions

Different alternatives to improve the coverage of the populational screening programmes of cervical cancer

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

30 Years – 70 Years

Sex

FEMALE

Inclusion Criteria:

20,994 women from 30 to 70 years of age with incorrect screening criteria (data obtained from Electronic Medical Records) ascribed to the Basic Health Care Area will be included in the study. Incorrect screening will be defined as \[9\]:

1. \- No cytology in the last 3 years from women between 30 to 40 years,
2. \- No cytology in the previous 5 years from women between 40 to 65 years,
3. \- No previous cytology history for females older than 65 years or women who have not had their last cytology before the age of 60

Exclusion Criteria:

* hysterectomised women, with a current history of pre-malignant lesions (Atypical glandular cells of undetermined significance, Atypical squamous cells of undetermined significance, Low grade Squamous Intraepithelial Lesion, High grade Squamous Intraepithelial Lesion), carcinoma in situ and cervical-uterine cancer, HIV positive or other causes of immunosuppression (since these women follow a specific protocol);
* those residing outside the study setting for more than 6 months;
* those ascribed to the study Basic Health Care Area but with a physician assigned in an UBA (General Practicioner and Nurse Team) of another zone different from the one considered in the study

Outcome Measures

Primary Outcomes

Clinical effectiveness measures

The main effectiveness measures of this evaluation would be the total number of cytologies performed, HPV infections detected, lesions of different grades detected, episodes of cancer detected and the number of deaths avoided

Time frame: Third year

Costs measures

Include costs of diagnosis, interventions and treatment for all women * Diagnosis: cost of cytology, HPV determination test and control visit by the midwife or gynaecologist * Interventions: cost of a full-time administrator, personalized screening invitation letters, informative leaflets and phone calls * Treatment: will depend on the state of health of the women but may include the costs of the visits to the gynaecologist, cytology tests, HPV determination, control visits with the physician, costs of radical hysterectomy, radiotherapy, chemotherapy, etc

Time frame: Third year

Locations

IDIAP Jordi Gol, Barcelona, Spain

Economic Evaluation of Three Populational Screening Strategies for Cervical Cancer