Colorectal CancerNCT03082911
A Telephone Intervention to Improve Participation in a Screening Program.
A study testing Phone call and Invitation letter in people with Colorectal Cancer and Colorectal Neoplasms, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Objective: To assess the effectiveness of a brief telephone intervention added to an post invitation letter in the participation rate to a colorectal cancer screening program. Methods: Randomized controlled trial. Read more about this study
- Who is it for?
- Ages 49 to 70 years
- Conditions the study is for
- Colorectal Cancer, Colorectal Neoplasms
- What is being tested?
- Phone call and Invitation letter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteSpain
- Study dates
- 13 Mar 2017to 20 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 49 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women and men from 50 to 69 years living in the selected territories (Terrassa C, Terrassa A, Cerdanyola del Vallès 1) that will be invited for the first time in the Colorectal cancer screening program.
Who cannot join
- The same as those used in the population program:
- History of colorectal cancer;
- History of inflammatory bowel disease;
- history of colorectal adenomas;
- family history of polyposis syndromes or hereditary nonpolyposis colorectal cancer;
- family history of colorectal cancer if: two first grade relatives affected or only one fist grade relative affected diagnosed before the age of 60;
Show all 10Show fewer
- terminal illness or severe disability which contraindicates the study of the colon. People is excluded temporally if:
- 1) they have a colonoscopy performed in the last 5 years;
- 2) present digestive signs or symptoms (rectal bleeding, change in bowel habits, abdominal pain, weight loss with fatigue and anorexia, abdominal mass);
- 3) they express the will to be out of the Program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Brief Telephone Intervention to Improve Participation in a Colorectal Cancer Screening Program: a Randomized Controlled Trial
Objective: To assess the effectiveness of a brief telephone intervention added to an post invitation letter in the participation rate to a colorectal cancer screening program.
Methods: Randomized controlled trial. This study is framed inside the colorectal cancer screening program of Catalonia, concretely in the region of Vallès Occidental. This program is directed to men and women from 50 to 69 years. The screening test used is the fecal immunological test (FIT) that is offered every 2 years. If the screening test is positive, a colonoscopy with sedation is offered as a diagnostic test.
- Conditions
- Colorectal Cancer, Colorectal Neoplasms
- Being tested
- Phone call, Invitation letter
- Keywords
- screening, early detection, participation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone callOther
A brief telephone intervention at the same time of sending the invitation letter plus the habitual invitation process used in the screening program (described in control group). Each phone call will last approximately 5 minutes.
Calls will be made by the administrative staff of the Screening Technical Office, which is experienced in telephone attention.
Invitation letterOther
The habitual invitation strategy used in the screening program . Three letters are send by post: 1- An invitation letter plus an information leaflet and a list of pharmacies in which people can obtain the screening test. 2- A reminder letter for those who have not participated after 5 weeks of sending the first letter. 3- A second reminder letter for those who have collected the kit in the pharmacy but have not returned it with the sample
| Study group | Role | What they receive |
|---|---|---|
| Phone call | Experimental | A brief telephone intervention at the same time of sending the invitation letter plus the habitual invitation process used in the screening program (described in control group).
Calls will be made by the administrative staff of the Screening Technical Office, which is experienced in telephone attention.
Each phone call will last approximately 5 minutes. Receives: Other: Phone call; Other: Invitation letter |
| Standard procedure | Active comparator | The habitual invitation strategy used in the screening program . Three letters are send by post: 1- An invitation letter plus an information leaflet and a list of pharmacies in which people can obtain the screening test. 2- A reminder letter for those who have not participated after 5 weeks of sending the first letter. 3- A second reminder letter for those who have collected the kit in the pharmacy but have not returned it with the sample. Receives: Other: Invitation letter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation
Participation is defined as the number of people who do the screening test to the total of people invited to the Program.
Measured: 6 months
Secondary outcomes (3)
Knowledge of the program
proportion of people from the intervention group who report knowing the existence of the program.
Measured: 1 day at the time of intervention administration
Comprehension of the information received
proportion of people from the intervention group who report having understood in which the screening program consists of.
Measured: 1 day at the time of intervention administration
Help to decide about participation
proportion of people from the intervention group who report that the information received in the phone call will be useful to decide about their participation in the program.
Measured: 1 day at the time of intervention administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start13 Mar 2017
- Primary completion31 Jul 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Selva, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082911
- Sponsor's protocol ID
- Corporació Parc Taulí
- Status last verified
- Jan 2019
- First submitted
- 13 Mar 2017
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Selva A, Tora N, Pascual E, Espinas JA, Bare M. Effectiveness of a brief phone intervention to increase participation in a population-based colorectal cancer screening programme: a randomized controlled trial. Colorectal Dis. 2019 Oct;21(10):1120-1129. doi: 10.1111/codi.14707. Epub 2019 Jun 17.
PubMed 31099455
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Brief Telephone Intervention to Improve Participation in a Colorectal Cancer Screening Program: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03082911
- Acronym / sponsor ID
- Corporació Parc Taulí
- Conditions
- Colorectal Cancer, Colorectal Neoplasms
- Keywords
- screening, early detection, participation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To assess the effectiveness of a brief telephone intervention added to an post invitation letter in the participation rate to a colorectal cancer screening program.
Methods: Randomized controlled trial. This study is framed inside the colorectal cancer screening program of Catalonia, concretely in the region of Vallès Occidental. This program is directed to men and women from 50 to 69 years. The screening test used is the fecal immunological test (FIT) that is offered every 2 years. If the screening test is positive, a colonoscopy with sedation is offered as a diagnostic test.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phone call | Experimental | Other: Phone call, Other: Invitation letterA brief telephone intervention at the same time of sending the invitation letter plus the habitual invitation process used in the screening program (described in control group). Calls will be made by the administrative staff of the Screening Technical Office, which is experienced in telephone attention. Each phone call will last approximately 5 minutes. |
| Standard procedure | Active comparator | Other: Invitation letterThe habitual invitation strategy used in the screening program . Three letters are send by post: 1- An invitation letter plus an information leaflet and a list of pharmacies in which people can obtain the screening test. 2- A reminder letter for those who have not participated after 5 weeks of sending the first letter. 3- A second reminder letter for those who have collected the kit in the pharmacy but have not returned it with the sample. |
Who may qualify
- Ages
- 49 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women and men from 50 to 69 years living in the selected territories (Terrassa C, Terrassa A, Cerdanyola del Vallès 1) that will be invited for the first time in the Colorectal cancer screening program.
Key exclusion criteria (10 listed)
- The same as those used in the population program:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone callA brief telephone intervention at the same time of sending the invitation letter plus the habitual invitation process used in the screening program (described in control group). Each phone call will last approximately 5 minutes. Calls will be made by the administrative staff of the Screening Technical Office, which is experienced in telephone attention. | Other | Phone call |
| Invitation letterThe habitual invitation strategy used in the screening program . Three letters are send by post: 1- An invitation letter plus an information leaflet and a list of pharmacies in which people can obtain the screening test. 2- A reminder letter for those who have not participated after 5 weeks of sending the first letter. 3- A second reminder letter for those who have collected the kit in the pharmacy but have not returned it with the sample | Other | Phone call, Standard procedure |
Primary outcome
Participation
Time frame: 6 months
Participation is defined as the number of people who do the screening test to the total of people invited to the Program.
3 secondary outcomes
Knowledge of the program
Time frame: 1 day at the time of intervention administration
Comprehension of the information received
Time frame: 1 day at the time of intervention administration
Help to decide about participation
Time frame: 1 day at the time of intervention administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Derived from this study: PubMed 31099455Selva A, Tora N, Pascual E, Espinas JA, Bare M. Effectiveness of a brief phone intervention to increase participation in a population-based colorectal cancer screening programme: a randomized controlled trial. Colorectal Dis. 2019 Oct;21(10):1120-1129. doi: 10.1111/codi.14707. Epub 2019 Jun 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone call and Invitation letter in people with Colorectal Cancer and Colorectal Neoplasms, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03082911, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.