ABSTRACT: Background and study aims
In European countries, colorectal cancer (CRC, also known as bowel cancer) represents an important public health problem. Screening by a faecal occult blood test (FOBT, a test for the detection of blood in the faeces which is not visually apparent) has proven to be effective in reducing CRC mortality. Currently, population-based screening programmes using FOBT have been or are heading towards being implemented in many European countries. Faecal immunochemical test (FIT, another test for the detection of blood in the faeces which is not visually apparent) has been adopted by most Italian regions as the default screening test. Flexible sigmoidoscopy (FS, an exam used to evaluate the lower part of the large intestine (colon) using a thin, flexible tube (sigmoidoscope) is inserted into the rectum) screening offered to people 58 years old has shown to reduce CRC. Although, the attendance rate in CRC screening programmes still remains suboptimal in Italy. Numerous international agencies recommend, among the tests able to identify CRC and precancerous lesions, CT Colonography (CTC), or “virtual colonoscopy”, with a five-year interval. Some trials have evaluated CTC as a screening test, with contradictory results. Recently a new approach based on “behavioural economics” (BE) concepts has been proposed with the aim to provide new insights into people’s behaviours and suggest new tools to promote screening uptake. Thus, the idea to design screening invitation letters according to new behavioural concepts seems appealing.
The aim of the project is to evaluate the impact on CRC screening attendance of different strategies for inviting people.
Who can participate?
For this study, 84,600 people of both gender and aged 54-70 years, non-respondents to FIT-based screening, will be randomised into six groups.
What does the study involve?
A total of 79,600 people will be invited to get a FIT; subjects randomised in arms 1a, 1b and 1c will be invited by mail with three different types of experimental letters drafted according to BE principles, whereas 40,000 subjects will be invited with a standard invitation letter (arm 2). Lastly, 3,000 subjects and 2,000 subjects will be invited to undergo an FS or a CTC examination, respectively (arm 3 and arm 4). Our project will be carried out in the territories of the three Local Health Units of Tuscany. The attendance rate will be compared among the six groups, in order to assess the efficacy of single strategies.
A qualitative phase will aim to develop the experimental invitation letter models containing messages drafted according to behavioural economics concepts of normative feedback and minority norm. This material will be evaluated through Interviews, in order to collect participants views on behavioural economics messages and to assess the comprehensibility and clarity of the texts. Interviews will be carried out with volunteers of both genders (selected from screening archives) non-respondents to CRC screening.
In this part of the project, the readability of the invitation letters will be also evaluated. In particular, possible reading comprehension difficulties met by subjects will be correlated with their personal information such as age, sex, etc. For this purpose, READ-IT (http://www.italianlp.it/demo/read-it/), the first readability assessment tool existing for the Italian language, will be exploited.
This study started from the pilot (involving ISPRO-Florence, CPO-Piedimont, ASL Roma 2-Lazio, Latina-Lazio) which aimed to increase participation in the FIT using strategies proposed by a new approach based on "behavioural economics”. The pilot involved a sample composed of 12,600 people randomly selected and allocated to the different arms. 50% of the participants belonged to the control group and received the standard invitation letter. The remaining 50% was divided into 3 equal large treatment groups and they were sent different invitation letters.
What are the possible benefit and risks of participation?
Subjects who usually do not respond to the screening invitation may choose to undertake the test due to the invitation strategy. In this case, the patient will benefit from the prevention efficacy of screening. The screening methodologies implemented in the tests are all validated and suggested at a national level. However, risks related to endoscopic procedures are different from those related to FIT tests.
Where is the study run from?
Institute for cancer research, prevention, and clinical network in Florence, Italy, is the coordinating centre of the project. The other centers involved in the study are CPO Piemonte, ASL Roma 2, ASL Latina, Local Health Unit Toscana Nord Ovest, Local Health Unit Toscana Sud-Est, Local Health Unit Toscana Centro.
When is the study starting and how long is it expected to run for?
January 2017 to December 2024.
Who is funding the study?
The pilot phase was part of a European Project funded by the European Commission [SRSS/S2018/066]. The full trial is funded by the Tuscany Region [DD 975 16/01/2020]
Who is the main contact?
Dr Paola Mantellini, p.mantellini@ispro.toscana.it
