Plain English Summary
Background and study aims
We carried out a study on subjects with a positive fecal occult blood test performed in the local colorectal cancer screening programme. Our goal was to find the best way to invite these subjects to undergo a total colonoscopy (TC).
Who can participate?
3800 subjects aged 50-69 years old, who attended nine colorectal cancer screening programmes in Italy.
What does the study involve?
The screening programmes invited subjects to undergo a fecal occult blood test (FOBT) every two years. Subjects with a positive FOBT (FOBT+) were invited to undergo a TC. During the study, FOBT+ subjects were randomly allocated to be invited to a TC in different ways:
1. Both first invitation and recall by mail
2. First invitation by phone, recall to non-compliers by mail
3. First invitation by phone, recall by face-to-face counseling with the General Practitioner
4. First invitation by phone, recall by an appointment with a specialist screening practitioner (nurse, healthcare assistant)
At the end of the study, we compared the uptake of TC of the groups of subjects who had received the different types of invitation.
What are the possible benefits and risks of participating?
Some of participants will receive a better method of invitation to a TC than the usual care of their local screening programme.
There will be no risks for those who participate in the study.
Where is the study run from?
The study was carried out by the Italian screening programmes of Belluno, Este (PD), Torino, Firenze, Lucca, Ferrara, Forlì, Perugia and Latina.
When is the study starting and how long is it expected to run for?
The study started in September 2010 and ran until March 2012.
Who is funding the study?
Italian Ministry of Health.
Who is the main contact?
Dr Manuel Zorzi
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RTV-2010-CCR-01
Study information
Scientific title
PARC (Promoting Adhesion to Referral for Colonoscopy) study: to compare different ways to invite subjects with a positive fecal occult blood test to colonoscopy an open, randomised, parallel group trial
Acronym
PARC
Study hypothesis
We compare the performances of different ways to invite subjects with a positive fecal occult blood test (FOBT+) to a total colonoscopy: mail vs phone call for the first invitation and mail vs counseling with the General Practitioner vs appointment with a specialist screening practitioner for recall of non compliers to first invitation.
Ethics approval
Not required as the study involved the use of different ways to invite people to a total colonoscopy, which are already currently used in the context of ongoing regional screening programmes, independently on their proven efficacy.
Furthermore, the nature of the intervention did not require obtaining informed consent by participants in the study.
Study design
Open randomised parallel group multi-site trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
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 programmes
Intervention
Subjects with a positive fecal occult blood test are randomized to be invited to a total colonoscopy in different ways:
1. Both first invitation and recall by mail
2. First invitation by phone, recall to non compliers by mail
3. First invitation by phone, recall by face-to-face counseling with the General Practitioner
4. First invitation by phone, recall by an appointment with a specialist screening practitioner (nurse, healthcare assistant)
The intervention is instantaneous: the subject is invited to a colonoscopy and we record whether the subject complies or not. Non-compliers to invitation are recalled within two months after first invitation. The follow-up lasts three further months in order to collect the information about late compliers. After three months, non-compliers were interviewed to find out whether they had undergone colonoscopy in a service outside the screening programme.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Compliance to the two methods of first invitation to a total colonoscopy: measured at the baseline
2. Compliance to the three methods of recall of non-compliers: measured after three months
Both outcomes are recorded by the endoscopist (or the nurse of the endoscopy service) through the management software of the screening programme.
Secondary outcome measures
Assessed three months after recruitment:
Uptake of total colonoscopy outside the endoscopy services adhering to the screening programme
Overall trial start date
01/09/2010
Overall trial end date
01/03/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Subjects (male and female) 50-69 years old invited to perform a fecal occult blood test by the local colorectal cancer screening programme
2. With a positive fecal occult blood test
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
3,750
Participant exclusion criteria
Subjects who did not give the consent to inform their General Practitioner of the result of the fecal occult blood test
Recruitment start date
01/09/2010
Recruitment end date
01/03/2012
Locations
Countries of recruitment
Italy
Trial participating centre
Registro Tumori del Veneto
Padova
35131
Italy
Funders
Funder type
Government
Funder name
Italian Ministry of Health (IT) (Italy) (ref: (Prot. n. 2015 del 24/07/2009 ASR Abruzzo)
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
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24811759
Publication citations
-
Results
Zorzi M, Giorgi Rossi P, Cogo C, Falcini F, Giorgi D, Grazzini G, Mariotti L, Matarese V, Soppelsa F, Senore C, Ferro A, , A comparison of different strategies used to invite subjects with a positive faecal occult blood test to a colonoscopy assessment. A randomised controlled trial in population-based screening programmes., Prev Med, 2014, 65, 70-76, doi: 10.1016/j.ypmed.2014.04.022.