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

NCT06972160 | Recruiting

• 1 other identifier: Rede+Rastreio-Cancro
• Study Type: interventional
• Target: 1,038
• Locations: 1 country
• Sites: 1

Brief 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 made by a physician).

Conditions

Colon and Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

  From April 2025 to June 2025 (6 weeks)

Study Arms (2)

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.

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.

Other: Control group

Interventions

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)

Interventional Group

Control group OTHER

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

Control group

Eligibility Criteria

• Age: 49 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Local Health Unit Barcelos/Esposende, Public Health Unit: lead
• Instituto de Saude Publica da Universidade do Porto: collaborator

Study Sites (1)

Public Health Unit Barcelos/Esposende

Porto, 4051-401, Portugal

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Marina Barroso Pinheiro MD, PhD, PhD

CONTACT

+351962654712; mpinheiro@icbas.up.pt

David Nascimento Moreira MD, Master

CONTACT

+351962692301; dnmoreira@ulsbe.min-saude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Public Health Medical Doctor, Local Health Authority

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 14, 2025
• Study Start: April 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

PT (1)