Trying to improve the compliance to colorectal cancer screening: type of test provider (GP versus hospital) and type of faecal occult blood test (Guaiac versus immunochemical)

ISRCTN	ISRCTN83029072
DOI	https://doi.org/10.1186/ISRCTN83029072
Secondary identifying numbers	N/A

Submission date: 05/09/2005
Registration date: 09/09/2005
Last edited: 15/01/2008

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

Agency for Public Health, Lazio Region
via 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)	Not specified
Study type	Screening
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/10/2002
Completion date	30/04/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	We randomised 7320 subjects
Key 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.
Key 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.
Date of first enrolment	01/10/2002
Date of final enrolment	30/04/2003

Locations

Countries of recruitment

Italy

Study participating centre

Agency for Public Health, Lazio Region

Rome
00198
Italy

Sponsor information

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

via S Costanza 53
Rome
00198
Italy

Phone	+39 (0)683060300
Email	splendori@asplazio.it
Website	http://www.asplazio.it

Funders

Funder type

Government

The study is funded exclusively by the Agency for Public Health of the Lazio Region (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	Peer reviewed?	Patient-facing?
Results article	Cluster results	01/02/2005	Yes	No
Other publications	Study design	01/06/2005	Yes	No
Other publications	Survey	01/07/2005	Yes	No
Results article	Case controlled study results	01/12/2005	Yes	No
Results article	Results	01/02/2006	Yes	No