Mailing of the Faecal Occult Blood Test (FOBT) to increase compliance to colorectal cancer screening and to reduce costs
| ISRCTN | ISRCTN10351276 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10351276 |
| Protocol serial number | N/A |
| Sponsor | Ministry of Health, Centre for Diseases Prevention amd Control (Italy) |
| Funder | Ministry of Health, Centre for Diseases Prevention amd Control (Italy) |
- Submission date
- 08/09/2009
- Registration date
- 18/05/2010
- Last edited
- 29/12/2020
- 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
Scientific
Laziosanità - Agenzia di Sanità Pubblica
Via di S. Costanza 53
Rome
00198
Italy
| Phone | +39 (0)683060438 |
|---|---|
| giorgirossi@asplazio.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effect of mailing of the Faecal Occult Blood Test (FOBT) on compliance to colorectal cancer screening and on front office costs: a randomised controlled trial |
| Study acronym | FOBT postale |
| Study objectives | European Commission Guidelines on cancer prevention recommend to the member states the implementation of colorectal cancer screening programmes based on the Faecal Occult Blood Test (FOBT) every two years in the population 50-70 years old. In Italy, colorectal cancer screening is affected by low compliance. Furthermore the front office activities to give the faecal sampler to the participants are time and cost consuming. A direct mailing strategy of the faecal sampler could increase compliance and could reduce the resource consumption of the front office activities. |
| Ethics approval(s) | Ethics approval is not required as this study involves only service provision that is already recommended by the European Commission. |
| Health condition(s) or problem(s) studied | Compliance to colorectal cancer screening |
| Intervention | The trial is recruiting at the following four centres: Viterbo, Latina, Firenze, Abruzzo Group 1: Participants randomised to either direct mailing of the FOBT or re-call letter Group 2: Participants randomised to either direct mailing of the FOBT or invitation letter |
| Intervention type | Other |
| Primary outcome measure(s) |
Compliance to screening at 60 days after mailing (of the FOBT or of the letter). |
| Key secondary outcome measure(s) |
Costs of mailing compared to front office. |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 4800 |
| Total final enrolment | 7415 |
| Key inclusion criteria | Group 1 (non responders): all the target population (both males and females, age 50-70) invited for a new round of screening and who did not responded to the first invitation letter and is eligible for a re-call letter. Group 2 (responders to previous screening): all the people who responded to the previous screening round (both males and females, age 52-70) and are eligible for being invited to a new screening round |
| Key exclusion criteria | Group 1: None Group 2: A previous positive test including FOBT, flexosigmoidoscopy and colonoscopy |
| Date of first enrolment | 01/03/2009 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Italy
Study participating centre
Laziosanità - Agenzia di Sanità Pubblica
Rome
00198
Italy
00198
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/09/2011 | 29/12/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
29/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
