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

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Local Health Unit Barcelos/Esposende, Public Health Unit

Status

Enrolling

Conditions

Colon and Rectal Cancer

Treatments

Other: Arm1: intervention 1 (SMS+call)
Other: Control group

Study type

Interventional

Funder types

Other

Identifiers

NCT06972160
Rede+Rastreio-Cancro

Details and patient eligibility

About

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).

Enrollment

1,038 estimated patients

Sex

All

Ages

49 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,038 participants in 2 patient groups, including a placebo group

Interventional Group
Experimental group
Description:
The interventional group will be subjected to interventions to increase the adherence to screening, including text messages via phone as well as phone calls.
Treatment:
Other: Arm1: intervention 1 (SMS+call)
Control group
Placebo Comparator group
Description:
The control group will not be subjected to any interventions to increase the adherence to screening.
Treatment:
Other: Control group

Trial contacts and locations

1

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Central trial contact

Marina Barroso Pinheiro MD, PhD, PhD; David Nascimento Moreira MD, Master

Data sourced from clinicaltrials.gov

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