Intervention Project to Increase Adherence to Colorectal Cancer Screening in Barcelos/Esposende

NCT ID: NCT06972160

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1038 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Colon and Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Interventional Group

The interventional group will be subjected to interventions to increase the adherence to screening, including text messages via phone as well as phone calls.

Group Type EXPERIMENTAL

Arm1: intervention 1 (SMS+call)

Intervention Type 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 group

The control group will not be subjected to any interventions to increase the adherence to screening.

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type OTHER

The control group will not be subjected to any interventions to increase the adherence to screening.

Interventions

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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)

Intervention Type OTHER

Control group

The control group will not be subjected to any interventions to increase the adherence to screening.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Participants must be registered in the ULS of

Barcelos/Esposende and meet the following criteria:

1. Age between 50 and 74 years.
2. No symptoms such as weight loss in the last 6 months or gastrointestinal symptoms.
3. No prior diagnosis of CRC.
4. No diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease).
5. No family history of CRC in first- and second-degree relatives diagnosed before age 60.
6. 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.

Exclusion Criteria

1. Participants who did not receive the screening kit at home.
2. Participants without a phone number.
3. Participants who do not answer the phone or refuse to participate in the study.
4. Participants unable to consent or perform the screening due to physical, mental, or other conditions that seriously impair comprehension.
Minimum Eligible Age

49 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto de Saude Publica da Universidade do Porto

OTHER

Sponsor Role collaborator

Local Health Unit Barcelos/Esposende, Public Health Unit

OTHER_GOV

Sponsor Role lead

Responsible Party

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David Nascimento Moreira

Public Health Medical Doctor, Local Health Authority

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Public Health Unit Barcelos/Esposende

Porto, , Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Marina Barroso Pinheiro MD, PhD, PhD

Role: CONTACT

+351962654712

David Nascimento Moreira MD, Master

Role: CONTACT

+351962692301

Facility Contacts

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Marina Pinheiro MD, PhD, PhD

Role: primary

+351962654712

Other Identifiers

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Rede+Rastreio-Cancro

Identifier Type: -

Identifier Source: org_study_id

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