Condition category
Cancer
Date applied
28/01/2013
Date assigned
19/02/2013
Last edited
16/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
An advance notification letter conveying information on colorectal cancer (CRC) risk and the intervention offered in the screening programme, may increase the likelihood of a positive response to the subsequent screening invitation, as the subject will have progressed in his degree of readiness for change. In addition, it has been shown that, in particular for less educated subjects, general practitioner’s (GP) advice may have a strong influence on the decision to be screened. The study aims to assess the impact on the response rate to the invitation for CRC screening, in the context of population based programs, of an advance notification letter mailed to subjects eligible for invitation. The additional cost per person examined and the additional workload for the subjects’ GPs will be assessed.

Who can participate?
All subjects (male and female) aged 50 to 69 targeted for CRC screening in 8 population based programmes in Italy.

What does the study involve?
During the enrolment period all subjects targeted for invitation in these screening programs were randomly allocated to three groups:
A: standard personal invitation letter, signed by the GP, to undergo CRC screening
B: advance notification letter, mailed one month before the standard invitation letter (same as in A), conveying information on CRC risk, on the screening program and on the expected benefits and potential harms of screening
C: as in B, with the addition, in the advance notification letter, of the offer of a personal encounter with the subject’s GP, to discuss pros and cons of screening. The response rate across the different groups will be assessed at 6 months following the invitation letter.

What are the possible benefits and risks of participating?
People allocated to the intervention groups will have the opportunity to get additional information on the proposed screening, which may be helpful to orient their decision-making process, favoring an informed decision about participation. Available evidence suggests that no harm can be expected when people receive additional information. Subjects allocated to the control group (A) will follow the standard procedures offered to the general population in the study areas in a routine basis. They are not expected therefore to incur any additional risk.

Where is the study run from?
The study, coordinated by the centre of Verona, will be conducted in each trial centre by the local Screening Organization Unit; the data analysis will be performed by the CPO in Turin.

When is the study starting and how long is it expected to run for?
October 2010 to October 2012.

Who is funding the study?
Italian Ministry of Health; funding administration: ASR Abruzzo

Who is the main contact?
Dr Carlo Senore
carlo.senore@cpo.it

Trial website

Contact information

Type

Scientific

Primary contact

Dr Carlo Senore

ORCID ID

Contact details

Via S Francesco da Paola 31
Turin
10123
Italy
+39 011 6333890
carlo.senore@cpo.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Impact of an advance notification letter on participation in CRC screening. Is it different when using sigmoidoscopy or fecal occult blood test (FIT) screening?

Acronym

Study hypothesis

According to the trans-theoretical model of behavioural change, the adoption of preventive behaviours represents the final step of a multi-phase decision process. In this process the subject passes through a growing degree of readiness for change before actually engaging in the proposed behaviour. An advance notification letter conveying information on colorectal cancer risk, available preventive test, screening programme, may increase the likelihood of a positive response to the subsequent invitation letter offering the appointment for the screening test, as the subject will have progressed in his degree of readiness for change.

Ethics approval

Not required as the study involves just mailing of additional information to people who would be invited for CRC screening in the context of ongoing regional screening programmes

Study design

Randomised clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

'Not available in web format, please use the contact details below to request a patient information sheet

Condition

Colorectal cancer screening

Intervention

1. Standard invitation letter
2. Advance notification letter (mailed 1 month before the personal invitation letter conveying information on CRC risk, screening programme and screening test
3. Advance notification letter (mailed 1 month before the personal invitation letter conveying information on CRC risk, screening programme and screening test, signed by the subject's GP, offering the option of personal encounter with the GP.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Participation rate at 6 months from the invitation letter by study group and screening strategy (FIT and FS)

Secondary outcome measures

1. Participation rate at 6 months from the invitation stratified by previous screening history (FIT programmes only)
2. Costs of the different options
3. GP's workload and proportion of subjects who accept the offer of a personal encounter

Overall trial start date

01/10/2010

Overall trial end date

01/10/2012

Reason abandoned

Eligibility

Participant inclusion criteria

All subjects (male and female) aged 50 to 69 targeted for CRC screening in 8 population based programmes in Italy, using immunochemical fecal occult blood test (FIT) in 5 cases (biennial screening offered to subjects aged 50 to 69), or sigmoidoscopy (FS) in 3 cases (FS offered once in the lifetime to all subjecst aged 58-60)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2500 people in each group in each centre, i.e. 60,000 subjects

Participant exclusion criteria

1. People with personal or family (>1 first degree relative with CRC) of CRC
2. Inflammatory bowel disease
3. Inability to give an informed consent
4. Severe life-threatening disease

Recruitment start date

01/10/2010

Recruitment end date

01/10/2012

Locations

Countries of recruitment

Italy

Trial participating centre

Via S Francesco da Paola 31
Turin
10123
Italy

Sponsor information

Organisation

ASR Abruzzo (Italy)

Sponsor details

via Attilio Monti
9
Pescara
65127
Italy
+ 39 085450871
direzionegenerale@asrabruzzo.it

Sponsor type

Government

Website

http://www.asrabruzzo.it/

Funders

Funder type

Government

Funder name

Italian Ministry of Health (Italy) - Funding coordinated by the Abruzzo Regional Health Authority

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25602908

Publication citations

Additional files

Editorial Notes