A Telephone Intervention to Improve Participation in a Screening Program.

Study Overview
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Brief Summary
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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.

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

Conditions
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Colorectal Cancer, Colorectal Neoplasms

Intervention / Treatment
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* Other: Phone call
* Other: Invitation letter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 49 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phone call<br>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<br>* 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.<br>Other: Invitation letter<br>* 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<br>|
| Active Comparator: Standard procedure<br>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<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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screening, early detection, participation