Colon and Rectal CancerNCT06972160
Intervention Project to Increase Adherence to Colorectal Cancer Screening in Barcelos/Esposende
A study testing Arm1: intervention 1 (SMS+call) in people with Colon and Rectal Cancer, run by Local Health Unit Barcelos/Esposende, Public Health Unit at 1 site in Portugal.
Trial summary
An experimental study through a randomized clinical trial, without blinding (for participants and the research team), with a control group (not subject to intervention) and an intervention group (subject to two text messages, an automated non-human call or a call made by the administrative assistant, and a phone call… Read more about this study
- Who is it for?
- Ages 49 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon and Rectal Cancer
- What is being tested?
- Arm1: intervention 1 (SMS+call)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,038 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Apr 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be registered in the ULS of
- Barcelos/Esposende and meet the following criteria:
- Age between 50 and 74 years.
- No symptoms such as weight loss in the last 6 months or gastrointestinal symptoms.
- No prior diagnosis of CRC.
- No diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease).
- No family history of CRC in first- and second-degree relatives diagnosed before age 60.
- No prior fecal occult blood test (FOBT) in the 11 months before receiving the collection kit or no prior sigmoidoscopy or colonoscopy in the last 24 months.
Who cannot join
- Participants who did not receive the screening kit at home.
- Participants without a phone number.
- Participants who do not answer the phone or refuse to participate in the study.
- Participants unable to consent or perform the screening due to physical, mental, or other conditions that seriously impair comprehension.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Public Health Unit Barcelos/Esposende
Porto, 4051-401
Marina Pinheiro MD, PhD, PhD, +351962654712, mpinheiro@icbas.up.pt
About this study
Official title: Interventions to Increase Adherence to Colorectal Cancer Screening in Barcelos/Esposende: a Randomized Clinical Trial
An experimental study through a randomized clinical trial, without blinding (for participants and the research team), with a control group (not subject to intervention) and an intervention group (subject to two text messages, an automated non-human call or a call made by the administrative assistant, and a phone call made by a physician).
- Conditions
- Colon and Rectal Cancer
- Being tested
- Arm1: intervention 1 (SMS+call), Control group
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm1: intervention 1 (SMS+call)Other
The intervention will consist in two text messages (one and two weeks after received the screening test, respectively), an automated non-human call or a call made by the administrative assistant (three weeks after received the screening test), and a phone call made by a physician (four weeks after received the screening test)
Control groupOther
The control group will not be subjected to any interventions to increase the adherence to screening.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | The interventional group will be subjected to interventions to increase the adherence to screening, including text messages via phone as well as phone calls. Receives: Other: Arm1: intervention 1 (SMS+call) |
| Control group | Placebo comparator | The control group will not be subjected to any interventions to increase the adherence to screening. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to colon and rectal screening [Time Frame: 6 weeks]
Increase in adherence to colon and rectal screening
Proportion/cumulative proportion of patients who performed colon and rectal cancer screening among those who were invited to undergo it, after step 1 (SMS1), step 2 (SMS2), step 3 (administrative call) and step 4 (medical doctor call)
Measured: From April 2025 to June 2025 (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Apr 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon and Rectal 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
- None (open label)
- Enrolment
- 1,038 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Local Health Unit Barcelos/Esposende, Public Health Unit
- Sponsor type
- Other government
- Collaborators
- Instituto de Saude Publica da Universidade do Porto
- Responsible party
- Principal investigator, David Nascimento Moreira, Instituto de Saude Publica da Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972160
- Sponsor's protocol ID
- Rede+Rastreio-Cancro
- Status last verified
- May 2025
- First submitted
- 16 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We plan to share de-identified individual participant data (IPD) that underlie the results reported in this study, including text, tables, and figures. The data will be made available beginning six months after publication and will remain accessible for a period of five years. Access will be granted to researchers who submit a methodologically sound proposal, subject to approval by the study team. Along with the IPD, supporting documents such as the study protocol, statistical analysis plan, and informed consent form will also be available. Requests for data access should be directed to Marina Pinheiro, MD, PhD email: mpinheiro@icbas.up.pt.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Increase Adherence to Colorectal Cancer Screening in Barcelos/Esposende: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06972160
- Acronym / sponsor ID
- Rede+Rastreio-Cancro
- Conditions
- Colon and Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,038 participants (estimated)
- Lead sponsor
- Local Health Unit Barcelos/Esposende, Public Health UnitOther government
- Collaborators
- Instituto de Saude Publica da Universidade do Porto
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 May 2025 (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.
An experimental study through a randomized clinical trial, without blinding (for participants and the research team), with a control group (not subject to intervention) and an intervention group (subject to two text messages, an automated non-human call or a call made by the administrative assistant, and a phone call made by a physician).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Other: Arm1: intervention 1 (SMS+call)The interventional group will be subjected to interventions to increase the adherence to screening, including text messages via phone as well as phone calls. |
| Control group | Placebo comparator | Other: Control groupThe control group will not be subjected to any interventions to increase the adherence to screening. |
Who may qualify
- Ages
- 49 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants must be registered in the ULS of
- Age between 50 and 74 years.
- No symptoms such as weight loss in the last 6 months or gastrointestinal symptoms.
- No prior diagnosis of CRC.
- No diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease).
Key exclusion criteria (4 listed)
- Participants who did not receive the screening kit at home.
- Participants without a phone number.
- Participants who do not answer the phone or refuse to participate in the study.
- Participants unable to consent or perform the screening due to physical, mental, or other conditions that seriously impair comprehension.
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 |
|---|---|---|
| Arm1: intervention 1 (SMS+call)The intervention will consist in two text messages (one and two weeks after received the screening test, respectively), an automated non-human call or a call made by the administrative assistant (three weeks after received the screening test), and a phone call made by a physician (four weeks after received the screening test) | Other | Interventional Group |
| Control groupThe control group will not be subjected to any interventions to increase the adherence to screening. | Other | Control group |
Primary outcome
Adherence to colon and rectal screening [Time Frame: 6 weeks]
Time frame: From April 2025 to June 2025 (6 weeks)
Increase in adherence to colon and rectal screening Proportion/cumulative proportion of patients who performed colon and rectal cancer screening among those who were invited to undergo it, after step 1 (SMS1), step 2 (SMS2), step 3 (administrative call) and step 4 (medical doctor call)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: Undecided. We plan to share de-identified individual participant data (IPD) that underlie the results reported in this study, including text, tables, and figures. The data will be made available beginning six months after publication and will remain accessible for a period of five years. Access will be granted to researchers who submit a methodologically sound proposal, subject to approval by the study team. Along with the IPD, supporting documents such as the study protocol, statistical analysis plan, and informed consent form will also be available. Requests for data access should be directed to Marina Pinheiro, MD, PhD email: mpinheiro@icbas.up.pt.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm1: intervention 1 (SMS+call) in people with Colon and Rectal Cancer, run by Local Health Unit Barcelos/Esposende, Public Health Unit at 1 site in Portugal.
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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 14 May 2025. 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 Portugal. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marina Barroso Pinheiro MD, PhD, PhD (+351962654712, mpinheiro@icbas.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to colon and rectal screening [Time Frame: 6 weeks] (time frame: From April 2025 to June 2025 (6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2025.