A Telephone Intervention to Improve Participation in a Screening Program.

Corporacion Parc Tauli

Status: Completed

Conditions: Colorectal Neoplasms; Colorectal Cancer

Treatments: Other: Phone call; Other: Invitation letter

Study type: Interventional

Funder types: Other

Identifiers

NCT03082911

Corporació Parc Taulí

Details and patient eligibility

About

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.

Enrollment: 432 patients

Sex: All

Ages: 49 to 70 years old

Volunteers: No Healthy Volunteers

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:

  1. History of colorectal cancer;

  2. History of inflammatory bowel disease;

  3. history of colorectal adenomas;

  4. family history of polyposis syndromes or hereditary nonpolyposis colorectal cancer;

  5. family history of colorectal cancer if: two first grade relatives affected or only one fist grade relative affected diagnosed before the age of 60;

  6. 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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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432 participants in 2 patient groups

Phone call

Experimental group

Description:

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). Calls will be made by the administrative staff of the Screening Technical Office, which is experienced in telephone attention. Each phone call will last approximately 5 minutes.

Treatment:

Other: Invitation letter

Other: Phone call

Standard procedure

Active Comparator group

Description:

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.

Treatment:

Other: Invitation letter