PARC (Promoting Adhesion to Referral for Colonoscopy) study: to compare different ways to invite subjects with a positive fecal occult blood test to colonoscopy
| ISRCTN | ISRCTN68866180 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68866180 |
| Secondary identifying numbers | RTV-2010-CCR-01 |
- Submission date
- 28/08/2013
- Registration date
- 30/09/2013
- Last edited
- 12/05/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
Registro Tumori del Veneto
Istituto Oncologico Veneto IRCCS
Passaggio Gaudenzio, 1
Padova
35131
Italy
Study information
| Study design | Open randomised parallel group multi-site trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | PARC |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2010 |
| Completion date | 01/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 3,750 |
| Key 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 |
| Key exclusion criteria | Subjects who did not give the consent to inform their General Practitioner of the result of the fecal occult blood test |
| Date of first enrolment | 01/09/2010 |
| Date of final enrolment | 01/03/2012 |
Locations
Countries of recruitment
- Italy
Study participating centre
35131
Italy
Sponsor information
Government
Agenzia Sanitaria Regionale Abruzzo
via Attilio Monti, 9
Pescara
65127
Italy
"ROR" |
https://ror.org/00789fa95 |
|---|
Funders
Funder type
Government
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 | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2014 | Yes | No |
