A Telephone Intervention to Improve Participation in a Screening Program.

NCT03082911 | Completed

• 1 other identifier: Corporació Parc Taulí
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer; Colorectal Neoplasms

Keywords

screening; early detection; participation

Outcome Measures

Primary Outcomes (1)

• Participation

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

  6 months

Secondary Outcomes (3)

• Knowledge of the program

  1 day at the time of intervention administration

• Comprehension of the information received

  1 day at the time of intervention administration

• Help to decide about participation

  1 day at the time of intervention administration

Study Arms (2)

Phone call

EXPERIMENTAL

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.

Other: Phone call; Other: Invitation letter

Standard procedure

ACTIVE COMPARATOR

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.

Other: Invitation letter

Interventions

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.

Phone call

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

Phone call; Standard procedure

Eligibility Criteria

• Age: 49 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• \) they have a colonoscopy performed in the last 5 years;
• \) present digestive signs or symptoms (rectal bleeding, change in bowel habits, abdominal pain, weight loss with fatigue and anorexia, abdominal mass);
• \) they express the will to be out of the Program.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (1)

• Selva A, Tora N, Pascual E, Espinas JA, Bare M. Effectiveness of a brief phone intervention to increase participation in a population-based colorectal cancer screening programme: a randomized controlled trial. Colorectal Dis. 2019 Oct;21(10):1120-1129. doi: 10.1111/codi.14707. Epub 2019 Jun 17.

  PMID: 31099455 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor specialist in Preventive Medicine and Public Health

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 17, 2017
• Study Start: March 13, 2017
• Primary Completion: July 31, 2017
• Study Completion: December 20, 2017
• Last Updated: January 30, 2019

Record last verified: 2019-01

Locations

ES (1)