Young Adult-Mediated Intervention to Increase Colorectal Cancer ScreeningNCT05936931
Young Adult-Mediated Intervention to Increase Colorectal Cancer Screening
A study testing Changes in CRC screening awareness and intentions in people with Young Adult-Mediated Intervention to Increase Colorectal Cancer Screening, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Young Adult-Mediated Intervention to Increase Colorectal Cancer Screening
- What is being tested?
- Changes in CRC screening awareness and intentions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to 31 Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Participants in Aims 1 or 2 will be ineligible for Aim 3
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23289
Carrie Miller, Ph.D, 804-347-9054, glassmanca@vcu.edu
Carrie Miller, Ph.D
About this study
Official title: Developing a Young Adult-Mediated Intervention to Increase Colorectal Cancer Screening Among Rural Screening Age-Eligible Adults
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.
Read the 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.
- Being tested
- Changes in CRC screening awareness and intentions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changes in CRC screening awareness and intentionsBehavioural
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 group | Role | What they receive |
|---|---|---|
| Aim 3: Single arm, open-label, pre-test/post-test design pilot trial | Other | Single arm, open-label, pre-test/post-test design pilot trial Receives: Behavioral: Changes in CRC screening awareness and intentions |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRC screening knowledge and awareness
A composite index score on four awareness items and 14 knowledge items adopted from prior research
Measured: 2-months post-intervention
CRC screeningintentions
A single item, based on previous CRC screening research
Measured: 2-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start30 Nov 2026 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Young Adult-Mediated Intervention to Increase Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Carrie A Miller, PhD, MPH, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936931
- Sponsor's protocol ID
- IRB202300089
- Other IDs
- R03CA270837-01A1, HM20026698
- Status last verified
- Oct 2026
- First submitted
- 23 Jun 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual patient data.