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NCT Number: NCT06972160

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

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).

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Key information

Conditions

Colon and Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

49 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Public Health Unit Barcelos/Esposende

Porto, 4051-401, Portugal

Location status: Recruiting

Location contact

Marina Pinheiro MD, PhD, PhD

CONTACT

[email protected]

+351962654712

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • 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.

Treatment and study plan

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 Group

Other

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

Primary outcomes

  1. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

David Nascimento Moreira MD, Master

CONTACT

[email protected]

+351962692301

Marina Barroso Pinheiro MD, PhD, PhD

CONTACT

[email protected]

+351962654712

Sponsors and collaborators

Lead sponsor

Local Health Unit Barcelos/Esposende, Public Health Unit

Other Gov

Collaborators

  • Instituto de Saude Publica da Universidade do Porto

Registry information

Official study title

Interventions to Increase Adherence to Colorectal Cancer Screening in Barcelos/Esposende: a Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 14, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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