Condition category
Cancer
Date applied
08/09/2009
Date assigned
18/05/2010
Last edited
18/05/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.ccm-network.it

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes