- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05936931
Young Adult-Mediated Intervention to Increase Colorectal Cancer Screening
Developing a Young Adult-Mediated Intervention to Increase Colorectal Cancer Screening Among Rural Screening Age-Eligible Adults
Study Overview
Status
Intervention / Treatment
Detailed Description
Aim 1. Environmental Scan of Health Communications Landscape. Using quantitative methods, examine the health communications landscape of younger (25-44 years old) and older (45-75 years old) adults living in rural communities. N=300 survey responses (n=150 from each age group) will be analyzed to determine the primary channels and sources of health-related information, quantify the extent to which these residents engage in family communications about cancer screening, and identify potential strategies for upward communications. Individual factors (i.e., CRC screening knowledge, health literacy, and numeracy) and specific facilitators of and barriers to upward communication about CRC screening will be also assessed.
Aim 2. Message Development and Refinement. Using qualitative methods, develop and evaluate intervention components to facilitate effective upward communications about CRC prevention and screening. To accomplish this aim, we will: 1) use findings from Aim 1 to design intervention content and materials that leverage relevant communication channels and strategies, and address barriers to upward communication and 2) conduct n=9 focus groups with adult children 25-44 years of age (n=3), CRC screening age-eligible adults, 45-75 years old (n=3), and adult child/parent dyads (n=3), to assess message acceptability and refine key content areas. We will iterate and modify intervention components based on feedback.
Aim 3. Preliminary Testing. Using a single arm, open-label, pre-test post-test design (n=15 adult child/parent dyads), assess the impact of a young adult-mediated intervention to increase CRC screening among a paired age-eligible family member (e.g., parent/grandparent). The focus of the intervention will be on changes in CRC screening awareness and intentions among the age-eligible adult, but we hypothesize that the young adult could benefit as well. Thus, in addition to assessing feasibility and acceptability, we will assess changes in 1) CRC screening intentions among the age-eligible adults and 2) CRC health literacy and awareness of screening guidelines among the younger adult participant.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Carrie A Miller, PhD, MPH
- Phone Number: (804) 628-8188
- Email: carrie.a.miller@vcuhealth.org
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23289
- Virginia Commonwealth University
-
Contact:
- Carrie Miller, Ph.D
- Phone Number: 804-347-9054
- Email: glassmanca@vcu.edu
-
Principal Investigator:
- Carrie Miller, Ph.D
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Residents of counties in the Virginia/North Carolina CRC hotspot
- 25-75 years old
- Able to speak, write, and comprehend English
- Younger adult participants in Aims 3 must have an older, screening age-eligible relative with whom they speak with regularly (i.e., ≥ once every two weeks)
Exclusion Criteria:
• Participants in Aims 1 or 2 will be ineligible for Aim 3
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: Aim 3: Single arm, open-label, pre-test/post-test design pilot trial
Single arm, open-label, pre-test/post-test design pilot trial
|
Using a single arm, open-label, pre-test post-test design (n=15 adult child/parent dyads), assess the impact of a young adult-mediated intervention to increase CRC screening among a paired age-eligible family member (e.g., parent/grandparent).
The focus of the intervention will be on changes in CRC screening awareness and intentions among the age-eligible adult, but we hypothesize that the young adult could benefit as well.
Thus, in addition to assessing feasibility and acceptability, we will assess changes in 1) CRC screening intentions among the age-eligible adults and 2) CRC health literacy and awareness of screening guidelines among the younger adult participant.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CRC screening knowledge and awareness
Time Frame: 2-months post-intervention
|
A composite index score on four awareness items and 14 knowledge items adopted from prior research
|
2-months post-intervention
|
|
CRC screeningintentions
Time Frame: 2-months post-intervention
|
A single item, based on previous CRC screening research
|
2-months post-intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Carrie A Miller, PhD, MPH, Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start (Estimated)
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB202300089
- R03CA270837-01A1 (U.S. NIH Grant/Contract)
- HM20026698 (Other Identifier: Virginia Commonwealth University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
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