NCT05956353

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

June 27, 2023

Last Update Submit

April 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants screened and recruited

    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 Outcomes (1)

  • Constructs associated with effective implementation research

    1 year

Study Arms (1)

Stories for Change: Prevention (S4C) intervention

EXPERIMENTAL

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.

Behavioral: Digital Storytelling Intervention

Interventions

Culturally tailored narrative-based videos created by individuals to promote colorectal, breast and cervical cancer screening among eligible participants in a primary care practice.

Stories for Change: Prevention (S4C) intervention

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Moutain Park Health Center

Phoenix, Arizona, 85012, United States

Location

Hennepin Healthcare

Minneapolis, Minnesota, 55415, United States

Location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Links

Study Officials

  • Mark Weiland, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 27, 2023

First Posted

July 21, 2023

Study Start

August 1, 2023

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

April 11, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations