Condition category
Cancer
Date applied
28/08/2013
Date assigned
30/09/2013
Last edited
12/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Manuel Zorzi

ORCID ID

Contact details

Registro Tumori del Veneto
Istituto Oncologico Veneto IRCCS
Passaggio Gaudenzio
1
Padova
35131
Italy

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

Sponsor information

Organisation

Italian Ministry of Health (Italy)

Sponsor details

Agenzia Sanitaria Regionale Abruzzo
via Attilio Monti
9
Pescara
65127
Italy

Sponsor type

Government

Website

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

  1. 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.

Additional files

Editorial Notes