Back to resultsA Telephone Intervention to Improve Participation in a Screening Program.
Primary Purpose
Colorectal Cancer, Colorectal Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Phone call
Invitation letter
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer focused on measuring screening, early detection, participation
Eligibility Criteria
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.
Sites / Locations
- Corporació Sanitària Parc Taulí
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Phone call
Standard procedure
Arm 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.
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.
Outcomes
Primary Outcome Measures
Participation
Participation is defined as the number of people who do the screening test to the total of people invited to the Program.
Secondary Outcome Measures
Knowledge of the program
proportion of people from the intervention group who report knowing the existence of the program.
Comprehension of the information received
proportion of people from the intervention group who report having understood in which the screening program consists of.
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.
Full Information
NCT ID
NCT03082911
First Posted
March 13, 2017
Last Updated
January 29, 2019
Sponsor
Corporacion Parc Tauli
1. Study Identification
Unique Protocol Identification Number
NCT03082911
Brief Title
A Telephone Intervention to Improve Participation in a Screening Program.
Official Title
Effectiveness of a Brief Telephone Intervention to Improve Participation in a Colorectal Cancer Screening Program: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 13, 2017 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
December 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colorectal Neoplasms
Keywords
screening, early detection, participation
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
432 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phone call
Arm Type
Experimental
Arm 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.
Arm Title
Standard procedure
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Phone call
Intervention 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). 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
Intervention Name(s)
Invitation letter
Intervention 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
Primary Outcome Measure Information:
Title
Participation
Description
Participation is defined as the number of people who do the screening test to the total of people invited to the Program.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Knowledge of the program
Description
proportion of people from the intervention group who report knowing the existence of the program.
Time Frame
1 day at the time of intervention administration
Title
Comprehension of the information received
Description
proportion of people from the intervention group who report having understood in which the screening program consists of.
Time Frame
1 day at the time of intervention administration
Title
Help to decide about participation
Description
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.
Time Frame
1 day at the time of intervention administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
49 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Corporació Sanitària Parc Taulí
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
31099455
Citation
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.
Results Reference
derived
Learn more about this trial
A Telephone Intervention to Improve Participation in a Screening Program.
We'll reach out to this number within 24 hrs