- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06696534
Exploring Participant Preference for Screening Methods and Experience Into Colorectal Cancer Screening Programme (MS-Care)
The goal of this low-risk interventional study is to analyze participants' assessment of colorectal cancer screening program through screening method preference and experience after FOBT analysis in screaned participant population for colorectal cancer; could include any of the following: both sexes, age 50-69 years, asympthomatic volunteers. The main aims to answer are:
- Values of experience of participants into screening programme.
- Values of preferences of participants for screening methods.
Participants will answer two questionnaires and they'll be given their information and clinical data to investigator or health personnel.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marta Jimenez, PhD
- Phone Number: +34 637899149
- Email: mjimenez@amadix.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants ages from 50 to 69 years (both included) at the time of informed consent signed.
- Participants invited to participate in population-based screening programme who are eligible to undertake FOBT at the Primary Health Care Center.
- Participants should sign an informed consent. They must understand the nature, significance, implications, and risks of the clinical study before signing the informed consent form.
Exclusion Criteria:
- Participants who have not delivery a stool sample in the Primary Health Care Center before signing the informed consent form.
- Participants with a previous colonoscopy in consequence of a FOBT positive result.
- Participants who are in a dependent personal or non-medical relationship with the Sponsor or the Investigators.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: FIT/FOBT population
Average-risk population undergoing FIT/FOBT within the colorectal cancer screening programme.
|
Preference questionnaire for colorectal cancer screening methods
Experience questionnaire into colorectal cancer screening programme
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Value of questionnaires into screening programme
Time Frame: 12 months
|
The percentage of number of answers from each experience and preference questions
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maria A Perez, MD, Primary Health Care Centre Mar Báltico
- Principal Investigator: Ana Rita, MD, Unidade Local de Saúde de Santa Maria
Publications and helpful links
General Publications
- Adler A, Geiger S, Keil A, Bias H, Schatz P, deVos T, Dhein J, Zimmermann M, Tauber R, Wiedenmann B. Improving compliance to colorectal cancer screening using blood and stool based tests in patients refusing screening colonoscopy in Germany. BMC Gastroenterol. 2014 Oct 17;14:183. doi: 10.1186/1471-230X-14-183.
- Siegel RL, Wagle NS, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2023. CA Cancer J Clin. 2023 May-Jun;73(3):233-254. doi: 10.3322/caac.21772. Epub 2023 Mar 1.
- De Angelis R, Demuru E, Baili P, Troussard X, Katalinic A, Chirlaque Lopez MD, Innos K, Santaquilani M, Blum M, Ventura L, Paapsi K, Galasso R, Guevara M, Randi G, Bettio M, Botta L, Guzzinati S, Dal Maso L, Rossi S; EUROCARE-6 Working Group. Complete cancer prevalence in Europe in 2020 by disease duration and country (EUROCARE-6): a population-based study. Lancet Oncol. 2024 Mar;25(3):293-307. doi: 10.1016/S1470-2045(23)00646-0. Epub 2024 Jan 30.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMD-CCR-2024-01
- 2024-NDMH-5101_240046 (Other Grant/Funding Number: EIT-Health)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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