Interventions to Increase Adherence to Colorectal Cancer Screening in Barcelos/Esposende: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,038
- Locations
- 1
- Primary Endpoint
- Adherence to colon and rectal screening [Time Frame: 6 weeks]
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 49 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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.
Arms & Interventions
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.
Intervention: Arm1: intervention 1 (SMS+call) (Other)
Control group
The control group will not be subjected to any interventions to increase the adherence to screening.
Intervention: Control group (Other)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
No secondary outcomes reported
Investigators
David Nascimento Moreira
Public Health Medical Doctor, Local Health Authority
Instituto de Saude Publica da Universidade do Porto