NCT01373723

Brief Summary

The aim of this study was to compare the effectiveness and the costs of three types of population interventions to increase the number of female participants in the screening programmes for cancer of the cervix carried out by Primary Care in four Basic Health Care Areas.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20,994

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 15, 2011

Status Verified

June 1, 2011

Enrollment Period

2.3 years

First QC Date

June 10, 2011

Last Update Submit

June 14, 2011

Conditions

Keywords

Uterine Cervical Neoplasmscancer screeningCosts and Cost Analysiscost-effectiveness analysisClinical TrialPrimary Health Care

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    Third year

Study Arms (3)

invitation letter

EXPERIMENTAL

to participate in the screening

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

Invitation letter, informative leaflet and phone call reminder

EXPERIMENTAL

to participate in the screening

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

Invitation letter and informative leaflet

EXPERIMENTAL

to participate in the screening

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

Interventions

Cost-effectiveness analysis of 3 strategies to increase the recruitment of population screening for cervical cancer. These interventions will be compared to the current opportunistic screening strategy

Also known as: Cricerva
Invitation letter and informative leafletInvitation letter, informative leaflet and phone call reminderinvitation letter

Eligibility Criteria

Age30 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ,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 \[9\]:
  • \- No cytology in the last 3 years from women between 30 to 40 years,
  • \- No cytology in the previous 5 years from women between 40 to 65 years,
  • \- No previous cytology history for females older than 65 years or women who have not had their last cytology before the age of 60

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IDIAP Jordi Gol

Barcelona, Barcelona, Spain

RECRUITING

Related Publications (4)

  • Trapero-Bertran M, Acera Perez A, de Sanjose S, Manresa Dominguez JM, Rodriguez Capriles D, Rodriguez Martinez A, Bonet Simo JM, Sanchez Sanchez N, Hidalgo Valls P, Diaz Sanchis M. Cost-effectiveness of strategies to increase screening coverage for cervical cancer in Spain: the CRIVERVA study. BMC Public Health. 2017 Feb 14;17(1):194. doi: 10.1186/s12889-017-4115-0.

  • Acera A, Manresa JM, Rodriguez D, Rodriguez A, Bonet JM, Trapero-Bertran M, Hidalgo P, Sanchez N, de Sanjose S. Increasing Cervical Cancer Screening Coverage: A Randomised, Community-Based Clinical Trial. PLoS One. 2017 Jan 24;12(1):e0170371. doi: 10.1371/journal.pone.0170371. eCollection 2017.

  • Acera A, Manresa JM, Rodriguez D, Rodriguez A, Bonet JM, Sanchez N, Hidalgo P, Soteras P, Toran P, Trapero-Bertran M, Lozano I, De Sanjose S. Analysis of three strategies to increase screening coverage for cervical cancer in the general population of women aged 60 to 70 years: the CRICERVA study. BMC Womens Health. 2014 Jul 16;14:86. doi: 10.1186/1472-6874-14-86.

  • Acera A, Rodriguez A, Trapero-Bertran M, Soteras P, Sanchez N, Bonet JM, Manresa JM, Hidalgo P, Toran P, Prieto G. Economic evaluation of three populational screening strategies for cervical cancer in the county of Valles Occidental: CRICERVA clinical trial. BMC Health Serv Res. 2011 Oct 19;11:278. doi: 10.1186/1472-6963-11-278.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Amelia Acera, Doctor

    Institut CatalĂ  de la Salut (ICS)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JM Manresa, Doctor

CONTACT

Amelia Acera, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 10, 2011

First Posted

June 15, 2011

Study Start

September 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

June 15, 2011

Record last verified: 2011-06

Locations