A Telephone Intervention to Improve Participation in a Screening Program.

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms; Colorectal Cancer
• Intervention / Treatment: Other: Phone call; Other: Invitation letter

• Study Type: Interventional
• Enrollment (Actual): 432
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Corporacio Sanitaria Parc Tauli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 49 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Phone call; 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; 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.; Other: Invitation letter; 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
ACTIVE_COMPARATOR: Standard procedure; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge of the program	proportion of people from the intervention group who report knowing the existence of the program.	1 day at the time of intervention administration
Comprehension of the information received	proportion of people from the intervention group who report having understood in which the screening program consists of.	1 day at the time of intervention administration
Help to decide about participation	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.	1 day at the time of intervention administration

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 13, 2017
• Primary Completion (ACTUAL): July 31, 2017
• Study Completion (ACTUAL): December 20, 2017

Study Registration Dates

• First Submitted: March 13, 2017
• First Submitted That Met QC Criteria: March 16, 2017
• First Posted (ACTUAL): March 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: early detection; screening; participation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Corporació Parc Taulí

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No