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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
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Young Adult-Mediated Intervention to Increase Colorectal Cancer Screening

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    June 23, 2023
    Last Updated
    June 30, 2023
    Sponsor
    University of Florida
    Collaborators
    National Cancer Institute (NCI)
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    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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