Young Adult-Mediated Intervention to Increase Colorectal Cancer Screening
Primary Purpose
Young Adult-Mediated Intervention to Increase Colorectal Cancer Screening
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Changes in CRC screening awareness and intentions
Sponsored by
About this trial
This is an interventional screening trial for Young Adult-Mediated Intervention to Increase Colorectal Cancer Screening
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Aim 3: Single arm, open-label, pre-test/post-test design pilot trial
Arm Description
Single arm, open-label, pre-test/post-test design pilot trial
Outcomes
Primary Outcome Measures
CRC screening knowledge and awareness
A composite index score on four awareness items and 14 knowledge items adopted from prior research
CRC screeningintentions
A single item, based on previous CRC screening research
Secondary Outcome Measures
Full Information
NCT ID
NCT05936931
First Posted
June 23, 2023
Last Updated
June 30, 2023
Sponsor
University of Florida
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05936931
Brief Title
Young Adult-Mediated Intervention to Increase Colorectal Cancer Screening
Official Title
Developing a Young Adult-Mediated Intervention to Increase Colorectal Cancer Screening Among Rural Screening Age-Eligible Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will garner preliminary data to develop a young adult-mediated intervention whereby a younger family member encourages their older family member to get colorectal cancer (CRC) screening. In Aim 1, survey data from n=150 younger (25-44 years old) and n=150 older (45-75 years old) adults living in rural communities will be collected. In Aim 2, intervention components will be evaluated using n=9 focus groups. The novel intervention will be assessed via a pilot trial (n=15 adult child/parent dyads) in Aim 3.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Young Adult-Mediated Intervention to Increase Colorectal Cancer Screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aim 3: Single arm, open-label, pre-test/post-test design pilot trial
Arm Type
Other
Arm Description
Single arm, open-label, pre-test/post-test design pilot trial
Intervention Type
Behavioral
Intervention Name(s)
Changes in CRC screening awareness and intentions
Intervention Description
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.
Primary Outcome Measure Information:
Title
CRC screening knowledge and awareness
Description
A composite index score on four awareness items and 14 knowledge items adopted from prior research
Time Frame
2-months post-intervention
Title
CRC screeningintentions
Description
A single item, based on previous CRC screening research
Time Frame
2-months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carrie A Miller, PhD, MPH
Phone
(352) 392-0466
Email
carriemiller@ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Max Williams, MBA
Phone
(352) 392-0466
Email
mandomax@ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carrie A Miller, PhD, MPH
Organizational Affiliation
Univerisy of Florida
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Young Adult-Mediated Intervention to Increase Colorectal Cancer Screening
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