- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04293315
Screening of Colorectal Cancer in the Public Healthcare Sector in Argentina
Evaluation of the Effectiveness of a Collaborative Strategy to Increase the Screening of Colorectal Cancer in the Public Healthcare Sector in Argentina
Introduction: Early detection of certain types of cancer significantly increases the likelihood of successful treatment and reduces mortality from these causes. However, the use of screening and the early detection of selected tumors such as colorectal cancer (CRC) are lower than those expected in our country. The objective of this project is to evaluate the effectiveness of a multicomponent strategy that improves the screening and early detection of CRC in the population at risk of Primary Health Care Clinics (PCCs) of the public health system.
Population: people leaving in the catchment area of 10 selected primary care clinics from the public health system in the province of Mendoza, Argentina.
Design and methods: a Randomized clinical study by clusters. 10 PCCs will be included: 5 will be randomly assigned to receive an intervention to increase the CRC screening rates (improvement cycles) and 5 to the control arm (usual care). 150 participants will be included in each PCCs, in total, 1500 participants.
Intervention: An innovative vision is proposed, which combines a participatory and dynamic methodology based on improvement cycles. This approach includes the implementation of participatory learning sessions for health providers, involving the effectors of the design of the intervention. In the intervention branch at least 3 workshops (sessions) will be held with the members of the care system, in order to identify opportunities for improvement oriented to the design and application of an innovative intervention based on best practices. Each one of the sessions will constitute an analysis of the improvement cycle, following the following steps: 1) Selection of participants of the initial workshop; 2) Development of work model based on bibliographic review and initial qualitative phase; 3) Initial workshop with effectors for training in continuous improvement, objectives, interventions and data collection; 4) Learning workshops to discuss results, applicability of interventions and modifications to the work plan; 5) Closing session to evaluate preliminary results and discuss continuity of interventions beyond the project.
Outcomes: 1) Percentage of the population at risk that completes the screening; 2) Percentage of the population classified as at habitual risk or increased by risk factors.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Mendoza, Argentina
- Ministry of Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects who have public health coverage
- Age between 50 and 75 years old
- Residence in the catchment area of the PCCs
- With an indication to perform screening for CRC with FOBT
- People who consent to participate
Exclusion Criteria:
- People who are bedridden.
- People who plan to move in the next 3 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
This is the usual care arm.
Healthcare workers will provide people with the Fecal Occult Blood Test (FOBT) and information about risk to develop CRC and the importance of early detection.
|
|
Experimental: Intervention
The same as the Control Arm plus the primary care team of the PCCs will be trained and participate in 8 improvement cycles.
|
This is a multi-component intervention following the Institute for Healthcare Improvement (IHI)'s Collaborative Model for Achieving Breakthrough Improvement by implementing "plan-do-study-act" (PDSA) improvement cycles.
The investigators will conduct 8 participative learning sessions for the primary care team.
These sessions will be aimed at identifying opportunities for improvement oriented to the design and application of innovative approaches based on best practices.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effective Screening
Time Frame: 3 months
|
Proportion of participants who with known result of the FOBT within 90 days from recruitment.
The investigators will review National Information System Registry to count the number of participants in each arm with a known result for their FOBT.
The investigators will calculate the proportion of participants with known result (Effective Screening) in each arm of the study.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants with inadequate FOBT
Time Frame: 3 months
|
The investigators will register the number of cases in each arm where the result of the FOBT is unknown because the test was inadequate, that is, the test could not be read.
|
3 months
|
Proportion of positive FOBT referred for colonoscopy
Time Frame: 3 months
|
The investigators will calculate the proportion of participants with a positive result in the FOBT that were referred to receive colonoscopy.
|
3 months
|
Implementation outcomes according to the RE-AIM framework
Time Frame: 3 months
|
Implementation outcomes are: Reach, Effective implementation, adoption, implementation fidelity and maintenance
|
3 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Vilma Irazola, Institute for Clinical Effectiveness and Health Policy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BID CCR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Colorectal Neoplasms
-
City of Hope Medical CenterRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Adenocarcinoma | Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Neoplasms Malignant | Colorectal Cancer Stage IUnited States, Japan, Italy, Spain
-
NuCana plcCompletedColorectal Neoplasms | Colorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalUnited States, France, United Kingdom
-
Emory UniversityBristol-Myers Squibb; National Cancer Institute (NCI); National Institutes of...Active, not recruitingColorectal Cancer Metastatic | Colorectal Adenocarcinoma | Stage IV Colorectal Cancer | Stage IVA Colorectal Cancer | Stage IVB Colorectal Cancer | Refractory Colorectal Carcinoma | Metastatic Microsatellite Stable Colorectal Carcinoma | Stage IVC Colorectal CancerUnited States
-
The Queen Elizabeth HospitalNovartis; AmgenCompletedColorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalAustralia
-
Novartis PharmaceuticalsCompletedColorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalUnited States
-
Pawel KalinskiNational Cancer Institute (NCI)CompletedColorectal Neoplasms | Colorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalUnited States
-
Jeremy MeyerUniversity Hospital, Geneva; Hôpital Fribourgeois; Spital Biel, SwitzerlandNot yet recruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Adenoma | Colorectal Adenocarcinoma | Colorectal Polyp | Colorectal Neoplasms Malignant | Colorectal Neoplasms, Benign
-
ProgenaBiomeRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Cancer Metastatic | Colorectal Carcinoma | Colorectal Adenocarcinoma | Colorectal SarcomaUnited States
-
Bristol-Myers SquibbNovartisActive, not recruitingColorectal Cancer | Colorectal Neoplasm | Colorectal Tumors | Colorectal CarcinomaItaly, United States, Canada, Spain, Argentina, Australia, Belgium, Chile, Czechia, Germany
-
City of Hope Medical CenterRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Disorders | Colorectal Adenocarcinoma | Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Polyp | Colorectal Neoplasms Malignant | Colorectal Adenomatous Polyp | Colorectal Cancer Stage I | Colorectal Adenoma... and other conditionsUnited States, Italy, China, Spain, Japan
Clinical Trials on Improvement Cycles
-
Nationwide Children's HospitalChildren's Hospital of Philadelphia; Boston Children's Hospital; Emory University and other collaboratorsNot yet recruiting
-
North Eastern German Society of Gynaecological...Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestNot yet recruitingOvarian Cancer | Fallopian Tube Cancer | Primary Peritoneal Carcinoma | Clear Cell Carcinoma
-
Women's Hospital School Of Medicine Zhejiang UniversityNot yet recruiting
-
Istituto Scientifico Romagnolo per lo Studio e...CompletedGastric Cancer | Locally Advanced Malignant NeoplasmItaly
-
Ruijin HospitalRecruiting
-
Fonds de la Recherche en Santé du QuébecUniversité de MontréalCompletedHypertension | Diabetes Mellitus, Type 2 | Dyslipidemias | Cholesterol, LDL | ComorbitdityCanada
-
Institute for Clinical Effectiveness and Health...Ministry of Public Health, ArgentinaUnknownCardiovascular Diseases | Quality ImprovementArgentina
-
Washington University School of MedicineEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedHealthy, Young AdultsUnited States
-
G. d'Annunzio UniversityA.O. Ospedale Papa Giovanni XXIIINot yet recruitingPPH - Postpartum HemorrhageItaly