- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05956353
Stories for Change: Early Detection Can Save Lives
April 9, 2024 updated by: Mark L Wieland, Mayo Clinic
The purpose of this study is to evaluate the Stories for Change (S4C) Cancer Prevention digital storytelling intervention for acceptability and socio-behavioral constructs to increase cancer screening among Hispanic or Latino individuals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85012
- Moutain Park Health Center
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55415
- Hennepin Healthcare
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic Minnesota
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Self-identify as Hispanic, Latino/a/x/e, or Chicano/a/x;
- For breast cancer screening: age 40-74 years; for cervical cancer screening: age 21-65 years; for colorectal cancer screening: age 45-75 year
- Receive primary care at either Hennepin Healthcare (HH) or Mountain Park Health Center (MPHC), or Mayo Clinic.
- At least one office visit within the previous 12 months to the primary care site.
- Eligibility for breast, cervical, or colorectal cancer screening documented in the electronic medical record (EMR).
- Intention to continue to receive medical care at HH, MPHC or Mayo Clinic for the next three months.
If a potential participant is eligible for more than one screening, they will be given the option of participating in multiple versions of the intervention.
Exclusion Criteria:
- Individuals with previous breast, cervical, or colorectal cancer diagnoses.
- For the participants in the colorectal cancer screening intervention, those under surveillance (i.e., did not have a cancer diagnosis but did have polyps) will also be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
Experimental: Stories for Change: Prevention (S4C) intervention
Participants who are due or overdue for cancer screening will receive the digital storytelling intervention and complete a cross-sectional survey to assess intervention acceptability, socio-behavioral constructs, and theory-based constructs.
|
Culturally tailored narrative-based videos created by individuals to promote colorectal, breast and cervical cancer screening among eligible participants in a primary care practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants screened and recruited
Time Frame: 1 year
|
Our primary measure is the number of participants screened and recruited.
We need this information to calculate the number needed to screen in order to recruit one participant from each site in our future randomized controlled trial.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Constructs associated with effective implementation research
Time Frame: 1 year
|
Our secondary measure will utilize the Consolidated Framework for Implementation Research.
We need this information to identify recruitment successes and opportunities for change in our future randomized controlled trial.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mark Weiland, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2023
Primary Completion (Actual)
March 31, 2024
Study Completion (Actual)
March 31, 2024
Study Registration Dates
First Submitted
June 27, 2023
First Submitted That Met QC Criteria
July 13, 2023
First Posted (Actual)
July 21, 2023
Study Record Updates
Last Update Posted (Actual)
April 11, 2024
Last Update Submitted That Met QC Criteria
April 9, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 23-001860
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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 Prevention
-
University of Puerto Rico Comprehensive Cancer...CompletedBreast Cancer Prevention | Colorectal Cancer Prevention | Cervical Cancer PreventionPuerto Rico
-
Brown UniversityNot yet recruitingFall | Fall Prevention | Fall Injury Prevention
-
Children's Hospital of PhiladelphiaUniversity of Pennsylvania; National Institute of Nursing Research (NINR); Pennsylvania...CompletedPrevention Harmful Effects | Accidents, Traffic | Accident PreventionUnited States
-
Duke UniversityGilead SciencesRecruitingHIV Prevention | HIV Pre-exposure Prophylaxis | HIV Prevention Program | HIV Prevention and Care | HIV Pre-exposure Prophylaxis UseUnited States
-
University of California, San DiegoNational Center for Advancing Translational Sciences (NCATS); Sanford Burnham...Active, not recruitingFall Prevention | Fall Prevention in Healthy AgingUnited States
-
Prof Mags BeksinskaCompletedHIV Prevention | Pregnancy PreventionSouth Africa
-
Yale UniversityCompletedHIV Prevention | STI PreventionUnited States
-
Centers for Disease Control and PreventionUniversity of Minnesota; The Fenway Institute; AIDS Action Committee of Massachusetts and other collaboratorsCompletedHIV Prevention | STD PreventionUnited States
-
University of WashingtonNational Institute of Nursing Research (NINR)RecruitingFruit and Vegetable Consumption | Hispanic Americans | Cancer Prevention | Chronic Disease PreventionUnited States
-
University of St.GallenRecruiting
Clinical Trials on Digital Storytelling Intervention
-
Mayo ClinicCompletedType2 DiabetesUnited States
-
Mayo ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Hennepin... and other collaboratorsCompletedType2 DiabetesUnited States
-
Mayo ClinicHennepin Healthcare Research Institute; Mountain Park Health CenterCompleted
-
Arizona State UniversityNational Cancer Institute (NCI); Mayo ClinicCompletedDepression | Stress | Anxiety | Hematopoietic Stem Cell Transplantation | Bone Marrow Transplant | Information Disclosure | Psychosocial Health | NarrativeUnited States
-
Arizona State UniversityNational Institute on Minority Health and Health Disparities (NIMHD)CompletedHealth Knowledge, Attitudes, Practice | Human Papilloma Virus | Preventable Disease, Vaccine | NarrativeUnited States
-
Vanderbilt UniversityRita & Alex Hillman FoundationCompleted
-
The Hong Kong Polytechnic UniversityHong Kong Children's Hospital; Research Grants Council, Hong KongRecruiting
-
Kocaeli UniversityGazi UniversityCompletedCancer | Child, Only | Symptoms and Signs | NarrationTurkey (Türkiye)
-
Michigan State UniversityRecruiting