Condition category
Cancer
Date applied
05/09/2005
Date assigned
09/09/2005
Last edited
15/01/2008
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

Agency for Public Health
Lazio Region
via 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

Acronym

Study hypothesis

The efficacy of colorectal cancer screening (CRCS) using faecal occult blood test (FOBT) in reducing colorectal cancer (CRC) mortality in a population at generic risk, has been shown in several large randomized trials.

The screening programs need to contact the whole target population and involve as many people as possible in order to be actually effective. The scientific literature about the reasons for non-compliance have generated few definitive operational recommendations.

Two types of FOBT are now available: the Guaiac and the Immunochemical test. The sensitivity and specificity of the two tests are similar and do not clearly indicate which one is better for screening. The price of the immunochemical test is actually about 1.5 times higher than the Guaiac, but there are no data about the costs per person screened. The Guaiac test recommends three different evacuations, and requires the patient to store the samples, and follow dietary restrictions. The immunochemical test is recommended on a single evacuation and does not require dietary restrictions. The discomfort and embarrassment of faecal sampling and the dietary restrictions have been hypothesized to be determinants of non-compliance. This background may determine lower compliance to the Guaiac test.

Several guidelines for screening programme implementation recommend the involvement of general practitioners (GP) and family practitioners (FP); nevertheless the role of the GPs and FPs varies between countries and health service organizations, making this recommendation hard to implement. The Agency for Public Health of Lazio, Italy, decided to design a trial phase in order to plan an evidence-based implementation of the CRCS program. The aim of this approach is to guarantee that the efficacy of CRCS can be translated to effectiveness in a public health intervention. The screening strategy adopted was: yearly FOB testing for 50–74 year olds and, for positives, colonoscopy. A special focus was how to obtain a high compliance to screening; the topics studied were: GPs’ attitudes and practices, type of FOBT, test provider, and the individual reasons.

Studies included: a survey, a randomized factorial trial nested in the survey, and a case–control study nested in the trial.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Screening

Patient information sheet

Condition

Colorectal cancer

Intervention

Faecal occult blood test:
Two types of test: guaiac versus immunochemical
Two types of provider: General Practitioner versus Hospital gastroenterology centre

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Compliance to screening: (number of returned faeces samples)/(total number of invited subjects)

Secondary outcome measures

Positivity rate; variability of the positivity rate; rate of inadequate samples; positive predictive value.

Overall trial start date

01/10/2002

Overall trial end date

30/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

We selected 13 hospitals, out of 20 to participate in the screening programme, in order to represent all types of gastroenterology units (5 university hospitals, 2 large research hospitals, 6 local hospitals) and all geographic areas (7 in the metropolitan area of Rome, 2 in the outskirts of Rome, 4 in towns and small cities of the province). We included in a survey about screening attitudes all the GPs with an office in the 13 selected hospital districts. During the survey, all the GPs were asked to participate in a trial to evaluate the best strategies to enhance the compliance to CRCS. The conditions for eligibility of the GPs were: more than 100 people aged 50–74 in the practice population; a personal computer in the office; and consent to participate.

For each of the 13 districts we sampled 10 eligible GPs. The sampled GPs, primary sampling units, were randomised as follows: for each district, five to the immunochemical test and five to the Guaiac test. We sampled 2/10 of the target practice population for each GP; 1/10 of the population was randomised to the GP arm and 1/10 to the hospital arm.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

We randomised 7320 subjects

Participant exclusion criteria

We analysed the lists of randomised patients: the second member of a pair with the same telephone number was rejected and substituted, if assigned to a different arm.

Recruitment start date

01/10/2002

Recruitment end date

30/04/2003

Locations

Countries of recruitment

Italy

Trial participating centre

Agency for Public Health, Lazio Region
Rome
00198
Italy

Sponsor information

Organisation

Agency for Public Health, Lazio Region, Italy (Agenzia di Sanita Pubblica della Regione Lazio)

Sponsor details

via S Costanza 53
Rome
00198
Italy
+39 (0)683060300
splendori@asplazio.it

Sponsor type

Government

Website

http://www.asplazio.it

Funders

Funder type

Government

Funder name

The study is funded exclusively by the Agency for Public Health of the Lazio Region (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

Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16411052

Cluster results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15949119

Study design in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15911466

Survey in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15916990

Case controlled study results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16372903

Publication citations

  1. Results

    Federici A, Giorgi Rossi P, Bartolozzi F, Farchi S, Borgia P, Guastcchi G, The role of GPs in increasing compliance to colorectal cancer screening: a randomised controlled trial (Italy)., Cancer Causes Control, 2006, 17, 1, 45-52, doi: 10.1007/s10552-005-0380-9.

  2. Cluster results

    Federici A, Giorgi Rossi P, Borgia P, Bartolozzi F, Farchi S, Gausticchi G, The immunochemical faecal occult blood test leads to higher compliance than the guaiac for colorectal cancer screening programmes: a cluster randomized controlled trial., J Med Screen, 2005, 12, 2, 83-88, doi: 10.1258/0969141053908357.

  3. Study design

    Giorgi Rossi P, Federici A, Bartolozzi F, Farchi S, Borgia P, Guasticchi G, Trying to improve the compliance to colorectal cancer screening: a complex study design for a complex planning question., Contemp Clin Trials, 2005, 26, 3, 323-330, doi: 10.1016/j.cct.2005.01.005.

  4. Survey

    Federici A, Giorgi Rossi P, Bartolozzi F, Farchi S, Borgia P, Guasticchi G, Guastcchi G, Survey on colorectal cancer screening knowledge, attitudes, and practices of general practice physicians in Lazio, Italy., Prev Med, 2005, 41, 1, 30-35, doi: 10.1016/j.ypmed.2004.11.010.

  5. Case controlled study results

    Giorgi Rossi P, Federici A, Bartolozzi F, Farchi S, Borgia P, Guasticchi G, Understanding non-compliance to colorectal cancer screening: a case control study, nested in a randomised trial [ISRCTN83029072]., BMC Public Health, 2005, 5, 139, doi: 10.1186/1471-2458-5-139.

Additional files

Editorial Notes