Contact information
Type
Scientific
Primary contact
Mr Paolo Giorgi Rossi
ORCID ID
Contact details
Laziosanità - Agenzia di Sanità Pubblica
Via di S. Costanza 53
Rome
00198
Italy
+39 (0)683060438
giorgirossi@asplazio.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of mailing of the Faecal Occult Blood Test (FOBT) on compliance to colorectal cancer screening and on front office costs: a randomised controlled trial
Acronym
FOBT postale
Study hypothesis
European Commission Guidelines on cancer prevention recommend to the member states the implementation of colorectal cancer screening programmes based on the Faecal Occult Blood Test (FOBT) every two years in the population 50-70 years old. In Italy, colorectal cancer screening is affected by low compliance. Furthermore the front office activities to give the faecal sampler to the participants are time and cost consuming. A direct mailing strategy of the faecal sampler could increase compliance and could reduce the resource consumption of the front office activities.
Ethics approval
Ethics approval is not required as this study involves only service provision that is already recommended by the European Commission.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Compliance to colorectal cancer screening
Intervention
The trial is recruiting at the following four centres: Viterbo, Latina, Firenze, Abruzzo
Group 1: Participants randomised to either direct mailing of the FOBT or re-call letter
Group 2: Participants randomised to either direct mailing of the FOBT or invitation letter
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Compliance to screening at 60 days after mailing (of the FOBT or of the letter).
Secondary outcome measures
Costs of mailing compared to front office.
Overall trial start date
01/03/2009
Overall trial end date
31/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Group 1 (non responders): all the target population (both males and females, age 50-70) invited for a new round of screening and who did not responded to the first invitation letter and is eligible for a re-call letter.
Group 2 (responders to previous screening): all the people who responded to the previous screening round (both males and females, age 52-70) and are eligible for being invited to a new screening round
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Group 1: 2,700; Group 2: 2,100
Participant exclusion criteria
Group 1: None
Group 2: A previous positive test including FOBT, flexosigmoidoscopy and colonoscopy
Recruitment start date
01/03/2009
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Italy
Trial participating centre
Laziosanità - Agenzia di Sanità Pubblica
Rome
00198
Italy
Sponsor information
Organisation
Ministry of Health, Centre for Diseases Prevention amd Control (Italy)
Sponsor details
Viale Giorgio Ribotta
5
Rome
00144
Italy
an.federici@sanita.it
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Ministry of Health, Centre for Diseases Prevention amd Control (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list