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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04343950
Other study ID # ICO_UCC_202001
Secondary ID PI19/00226
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 15, 2020
Est. completion date December 31, 2022

Study information

Verified date April 2020
Source Institut Català d'Oncologia
Contact Montse Garcia, PhD
Phone +34932607205
Email mgarcia@iconcologia.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this project is to assess the impact on health and economics of the implementation of text messaging (SMS) in cancer screening programs. Three interventions with SMS will be evaluated through community trials. In the colorectal cancer screening program the following interventions will be tested: a) Participation reminder: six weeks after sending the invitation letter of the colorectal cancer program if there has not been a response, a reminder SMS will be sent in front of the usual method by letter; b) Reminder to return the fecal occult blood test: SMS reminder of test delivery versus no intervention. This reminder will be sent to the individuals who have gone to the pharmacy to pick up a fecal occult blood test and they have not returned it after 14 days. The impact on participation will be analyzed and, if applicable, the proportion of advanced neoplasms will be calculated by increase in participation. In the breast cancer screening program, the invitation by SMS versus the usual invitation by letter will be studied in women who had participated in the previous screening round. The impact on participation will be analyzed. A cost-effectiveness analysis of the three interventions will be carried out. The incremental cost ratio of the interventions between cost variation and effectiveness variation will be calculated.


Description:

Main Hypothesis:

The implementation of SMS in population-based cancer screening programs will improve participation, especially in colorectal cancer screening, will allow a better resource management and reduce costs in both programs.

Specific Hypothesis:

Sending the reminder SMS will have an impact on participation greater than that obtained with the standard reminder (letter) in the colorectal cancer screening program.

The effect of the colorectal cancer screening reminder SMS will be greater among the individuals who have been invited for the first time and not previous participants.

Participation after receiving the invitation by SMS in breast cancer screening will be equal to or better than the letter invitation.

The alternative that includes sending SMS will be cost-effective in relation to the current alternative that you use postal shipping.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20000
Est. completion date December 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 69 Years
Eligibility Inclusion Criteria:

- Eligible individuals for colorectal cancer screening (intervention 1 and 2)

- Eligible women for breast cancer screening (intervention 3)

- Registered at the HealthCare Database (RCA)

Exclusion Criteria:

- Individuals without a mobile phone number registered at the RCA

- Opt out from breast cancer screening and/or colorectal cancer screening

Study Design


Intervention

Behavioral:
SMS reminders to enhance colorectal cancer screening
Cluster randomization instead of individual randomization will be used. The cluster will be "invitation week". Individuals assigned to the experimental arm with a wrong phone number will get a reminder letter (protocol analysis).
SMS reminders to return the fecal immunochemical test at the pharmacy in CRC screening:
Cluster randomization instead of individual randomization will be used. The cluster will be "invitation week". Individuals with a wrong phone number assigned to the experimental arm will not get any reminder (protocol analysis).
Invitation by SMS to previous participants in breast cancer screening:
Individual randomization. Women assigned to the experimental arm and with a wrong phone number will get an invitation letter (protocol analysis).

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Institut Català d'Oncologia University of Barcelona, University of Dundee, University Rovira i Virgili

Outcome

Type Measure Description Time frame Safety issue
Primary Intervention 1: Participation in colorectal cancer screening program Participation (no/yes) will be gathered prospectively 18 weeks after sending the screening invitation letter (week 0). 18 weeks
Primary Intervention 2: Participation in colorectal cancer screening program among individuals who pick the test at the pharmacy Participation (no/yes) among those individuals who pick the screening test for colorectal cancer at the pharmacy 18 weeks after sending the screening invitation letter (week 0). 18 weeks
Primary Intervention 3: Participation in breast cancer screening program Participation (no/yes) will be gathered prospectively 8 weeks after sending the screening invitation letter (week 0). 8 weeks
Secondary Incremental cost ratio A cost-effectiveness analysis of the three interventions will be carried out. The incremental cost ratio of the interventions between cost variation and effectiveness variation will be calculated. 18 weeks
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