Trial Title:
Economic Evaluation of Three Populational Screening Strategies for Cervical Cancer
NCT ID:
NCT01373723
Condition:
Uterine Cervical Neoplasms
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
Uterine Cervical Neoplasms
cancer screening
Costs and Cost Analysis
cost-effectiveness analysis
Clinical Trial
Primary Health Care
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Different alternatives to improve the coverage of the populational screening programmes of cervical cancer
Description:
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
Arm group label:
Invitation letter and informative leaflet
Arm group label:
Invitation letter, informative leaflet and phone call reminder
Arm group label:
invitation letter
Other name:
Cricerva
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.
Detailed description:
Background A high percentage of cervical cancer cases have not undergone cytological
tests within 10 years prior to diagnosis. Different population interventions could
improve coverage in the public system, although costs will also increase. 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.
Methods A cost-effectiveness analysis will be performed from the perspective of public
health system including women from 30 to 70 years of age (n=20,994) with incorrect
screening criteria from four basic health care areas in the Valles Occidental, Barcelona,
Spain. The patients will be randomly distributed into the control group and the three
Intervention Groups (IG1: invitation letter to participate in the screening; IG2:
invitation letter and informative leaflet; IG3: invitation letter, informative leaflet
and a phone call reminder) and followed for three years. Clinical effectiveness will be
measured by the number of Human Papillomavirus (HPV), epithelial lesions and cancer of
cervix cases detected. The number of deaths avoided will be secondary measures of
effectiveness. The temporal horizon of the analysis will be the life expectancy of the
female population in the study. Costs and effectiveness will be discounted at 3 %. In
addition, univariate and multivariate sensitivity analysis will be carried out.
Expected results IG3 is expected to be more cost-effective intervention than IG1 and IG2,
with greater detection of HPV infections, epithelial lesions and cancer than other
strategies, albeit at a greater cost.
METHODS
An economic evaluation of three populational screening strategies for cervical cancer
will be performed. Particularly, a cost-effectiveness analysis will be conducted. These
interventions will be compared to the current opportunistic screening strategy using data
of the multicentre randomised trial (CRICERVA). The analysis will be conducted from the
National Health Care System perspective.
Design: Pragmatic, blinded, multicentre, randomised, controlled clinical trial with four
branches, and a three years follow-up. The randomisation unit was Basic Health Care Area
(BHCA).
Setting: Primary Health Care Services (PCS) of Cerdanyola-Ripollet, province of
Barcelona, comprising 4 municipalities and 5 BHCA. The population covered by this Primary
Care Service (PCS) is 120,293 inhabitants over 14 years. As there are four study groups
and 5 BHCAs, only 4 BHCAs with most homogeneous socioeconomic criteria will be
considered.
Population: 20,994 women from 30 to 70 years of age with incorrect screening criteria
(data obtained from Data Base of Primary Health Care Services) ascribed to the BHCA 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.
The exclusion criteria will be: (a) hysterectomised women, with a current history of
pre-malignant lesions [Atypical Glandular Cells of Undetermined Significance (AGUS),
Atypical Squamous Cells of Undetermined Significance (ASCUS), Low-grade Squamous
Intraepithelial Lesions (LSIL), High-grade Squamous Intraepithelial Lesions (HSIL)],
carcinoma in situ and cervical-uterine cancer, Human Immunodeficiency Virus (HIV)
positive or other causes of immunosuppression (since these women follow a specific
protocol); (b) those residing outside the study setting for more than 6 months; and (c)
those ascribed to the study BHCA but with a physician assigned in an UBA of another zone
different from the one considered in the study.
Sample size: The sample size has been calculated based on the detection of a difference
in effectiveness compared with the Non Intervention Group (NIG). It has been calculated
by multiplying the size of a simple randomised design by the design effect or factor of
inflation. For the simple randomised design, on accepting an alpha risk of 0.05 and a
beta risk of 0.20 in a bilateral contrast, 59 subjects will be required in the first
group and 59 in the second group to detect a difference greater than or equal to 28.4 %
in the screening coverage of the 41.6 % in the Non Intervention Group (NIG). The lost to
follow up rate has been estimated at 20 %. The calculation of the sample has been
performed with the Granmo 5.2 computer programme for Windows. According to a review of
the literature [23-25], considering an intraclass correlation coefficient of 0.05 and a
mean number of 3,500 women from 30 to 70 years of age with incorrect screening by BHCA,
the design effect will be 176 and thus, 20,768 women with incorrect screening will be
required.
ETHICAL ASPECTS The investigators are committed to respect the prevailing norms of Good
Clinical Practice as well as the requisites of the Declaration of Helsinki and the
clauses of general and particular ethical conditions related to the right to privacy,
anonymity and confidentiality. Neither the first name nor surname or any other type of
data indicating the identification of the women will be registered. Therefore,
identification will be made by numeric codes. Since this type of study is developed in
the usual clinical setting, authorisation and support must be and has already been
granted by the representatives and authorities of the collectives involved and thus,
individualised informed consent is not necessary. Nonetheless, the research team decided
that women attending the consultation for the cytology should sign the consent form. The
protocol has been evaluated by the Clinical Investigation Ethics Committee of the IDIAP
Jordi Gol.
LIMITATIONS Randomisation by groups will avoid the potential introduction of selection
bias which may be produced among the interventions performed at the same site. Since the
characteristics of the study do not allow the application of the double-blind masking
technique, the masked response evaluation will be used to ensure that the measurement and
interpretation of the dependent variables is carried out the same way in all groups. The
possible loss of information, which may be produced in women doing screening outside
public health care if they are not contacted by the research team, will be minimised with
a phone call reminder. This will be made when the women do not attend the appointment.
The language difficulties in women from other countries will be solved with cultural
mediators at each site. Within the setting of the study, the administrative personnel
have been updating the postal addresses of the users attending the BHCA since 2007 and,
therefore the postal registry is quite precise, thereby reducing the potential loss of
letters.
List of abbreviations
AETM Agency for Evaluation of Technology and Medical Investigation BHCA Basic Health Care
Area AGUS Atypical glandular cells of undetermined significance ASCUS Atypical squamous
cells of undetermined significance PCC Primary Care Centre ECCI Ethical Committee of
Clinical Investigation eCCN Electronic Data Collection Notebook PCT Primary Care Team
c-CH Computerised Clinical History IT Investigative Team IG Intervention Group NIG Non
intervention Group HC2 Hybrid Capture 2 HSIL High grade Squamous Intraepithelial Lesion
CIO Catalan Institute of Oncology CIH Catalan Institute of Health IIPC Institute of
Investigation in Primary Care LSIL Low grade Squamous Intraepithelial Lesion SRHC Sexual
and Reproductive Health Care PCS Primary Care Service ISU Investigation Support Unit HSV
Herpes Simple Virus HIV Human Immunodeficiency Virus HPV Human Papilloma Virus UBA Unitat
Bàsica Assistencial (General Practicioner and Nurse Team)
Financial support
This protocol has received financial support from the Fondo de Investigación Sanitaria
del Instituto Carlos III de Madrid (exp PI10/01275).
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
30 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
IDIAP Jordi Gol
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Contact:
Last name:
JM Manresa, BS MSc
Email:
jmanresa@idiapjgol.info
Contact backup:
Last name:
Pere Toran, MD
Email:
ptoran.bnm.ics@gencat.cat
Investigator:
Last name:
Amelia Acera, MD MSc
Email:
Principal Investigator
Investigator:
Last name:
Ana Rodriguez, Midwife
Email:
Sub-Investigator
Investigator:
Last name:
Marta Trapero
Email:
Sub-Investigator
Investigator:
Last name:
Pilar Soteras
Email:
Sub-Investigator
Investigator:
Last name:
Norman Sanchez
Email:
Sub-Investigator
Investigator:
Last name:
JM Bonet
Email:
Sub-Investigator
Investigator:
Last name:
JM Manresa, BS MSc
Email:
Sub-Investigator
Investigator:
Last name:
Pablo Hidalgo
Email:
Sub-Investigator
Investigator:
Last name:
Pere Toran
Email:
Sub-Investigator
Investigator:
Last name:
Gemma Prieto
Email:
Sub-Investigator
Start date:
September 2010
Completion date:
December 2013
Lead sponsor:
Agency:
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Agency class:
Other
Source:
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01373723
