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 5074 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 casecontrol 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 5074 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
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
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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.
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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.
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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.
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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.
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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.