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Completed

NCT Number: NCT03082911

A Telephone Intervention to Improve Participation in a Screening Program.

Objective: To assess the effectiveness of a brief telephone intervention added to an post invitation letter in the participation rate to a colorectal cancer screening program.

Methods: Randomized controlled trial. This study is framed inside the colorectal cancer screening program of Catalonia, concretely in the region of Vallès Occidental. This program is directed to men and women from 50 to 69 years. The screening test used is the fecal immunological test (FIT) that is offered every 2 years. If the screening test is positive, a colonoscopy with sedation is offered as a diagnostic test.

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Key information

Age range

49 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women and men from 50 to 69 years living in the selected territories (Terrassa C, Terrassa A, Cerdanyola del Vallès 1) that will be invited for the first time in the Colorectal cancer screening program.

Exclusion criteria

  • The same as those used in the population program:
  • History of colorectal cancer;
  • History of inflammatory bowel disease;
  • history of colorectal adenomas;
  • family history of polyposis syndromes or hereditary nonpolyposis colorectal cancer;
  • family history of colorectal cancer if: two first grade relatives affected or only one fist grade relative affected diagnosed before the age of 60;
  • terminal illness or severe disability which contraindicates the study of the colon. People is excluded temporally if:
  • 1) they have a colonoscopy performed in the last 5 years;
  • 2) present digestive signs or symptoms (rectal bleeding, change in bowel habits, abdominal pain, weight loss with fatigue and anorexia, abdominal mass);
  • 3) they express the will to be out of the Program.

Treatment and study plan

phone call

Other

A brief telephone intervention at the same time of sending the invitation letter plus the habitual invitation process used in the screening program (described in control group). Each phone call will last approximately 5 minutes.

Calls will be made by the administrative staff of the Screening Technical Office, which is experienced in telephone attention.

Invitation letter

Other

The habitual invitation strategy used in the screening program . Three letters are send by post: 1- An invitation letter plus an information leaflet and a list of pharmacies in which people can obtain the screening test. 2- A reminder letter for those who have not participated after 5 weeks of sending the first letter. 3- A second reminder letter for those who have collected the kit in the pharmacy but have not returned it with the sample

Primary outcomes

  1. Participation

    Time frame: 6 months

    Participation is defined as the number of people who do the screening test to the total of people invited to the Program.

Secondary outcomes

  1. Knowledge of the program

    Time frame: 1 day at the time of intervention administration

    proportion of people from the intervention group who report knowing the existence of the program.

  2. Comprehension of the information received

    Time frame: 1 day at the time of intervention administration

    proportion of people from the intervention group who report having understood in which the screening program consists of.

  3. Help to decide about participation

    Time frame: 1 day at the time of intervention administration

    proportion of people from the intervention group who report that the information received in the phone call will be useful to decide about their participation in the program.

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

Effectiveness of a Brief Telephone Intervention to Improve Participation in a Colorectal Cancer Screening Program: a Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 17, 2017
Registry last updated
Jan 30, 2019

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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