Clinical trial NCT06696534: Exploring Participant Preference for Screening Methods and Experience Into Colorectal Cancer Screening Programme
Official title: Exploring Participant Preference for Screening Methods and Experience Into Colorectal Cancer Screening Programme
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Screening for Colon Cancer
Survey and Questionnaire
Keywords: colorectal cancer
screening programme
experience
preference
questionnaire
Lead sponsor: ADVANCED MARKER DISCOVERY S.L.
Sponsor class: INDUSTRY
Collaborators: name: SERMAS
name: ULS de Santa Maria
First posted: 2024-11-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Value of questionnaires into screening programme
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: UCSP Sete Rios
city: Madrid
country: Spain
facility: CS Mar Báltico
Study officials:
affiliation: Primary Health Care Centre Mar Báltico
name: Maria A Perez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unidade Local de Saúde de Santa Maria
name: Ana Rita, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.