A Telephone Intervention to Improve Participation in a Screening Program.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

432 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-13

Study Completion Date

2017-12-20

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.

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Detailed Description

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Conditions

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Colorectal Cancer Colorectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Phone call

Intervention Type 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

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Invitation letter

Intervention Type 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

Interventions

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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.

Intervention Type 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

Intervention Type OTHER

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:

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.

Minimum Eligible Age

49 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No