Mailing of the Faecal Occult Blood Test (FOBT) to increase compliance to colorectal cancer screening and to reduce costs

ISRCTN	ISRCTN10351276
DOI	https://doi.org/10.1186/ISRCTN10351276
Secondary identifying numbers	N/A

Submission date: 08/09/2009
Registration date: 18/05/2010
Last edited: 29/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Paolo Giorgi Rossi
Scientific

Laziosanità - Agenzia di Sanità Pubblica
Via di S. Costanza 53
Rome
00198
Italy

Phone	+39 (0)683060438
Email	giorgirossi@asplazio.it

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	FOBT postale
Study objectives	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(s)	Ethics approval is not required as this study involves only service provision that is already recommended by the European Commission.
Health condition(s) or problem(s) studied	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
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 study start date	01/03/2009
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Group 1: 2,700; Group 2: 2,100
Total final enrolment	7415
Key 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
Key exclusion criteria	Group 1: None Group 2: A previous positive test including FOBT, flexosigmoidoscopy and colonoscopy
Date of first enrolment	01/03/2009
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Italy

Study participating centre

Laziosanità - Agenzia di Sanità Pubblica

Rome
00198
Italy

Sponsor information

Ministry of Health, Centre for Diseases Prevention amd Control (Italy)
Government

Viale Giorgio Ribotta, 5
Rome
00144
Italy

Email	an.federici@sanita.it
Website	http://www.ccm-network.it
"ROR"	https://ror.org/00svmjx28

Funders

Funder type

Government

Ministry of Health, Centre for Diseases Prevention amd Control (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2011	29/12/2020	Yes	No

Editorial Notes

29/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.