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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Young Adult-Mediated Intervention to Increase Colorectal Cancer Screening Among Rural Screening Age-Eligible Adults
- ClinicalTrials.gov ID
- NCT05936931
- Acronym / sponsor ID
- IRB202300089
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aim 3: Single arm, open-label, pre-test/post-test design pilot trial | Other | Behavioral: Changes in CRC screening awareness and intentionsSingle arm, open-label, pre-test/post-test design pilot trial |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- Participants in Aims 1 or 2 will be ineligible for Aim 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Changes in CRC screening awareness and intentionsUsing 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. | Behavioural | Aim 3: Single arm, open-label, pre-test/post-test design pilot trial |
Primary outcome
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
CRC screeningintentions
Time frame: 2-months post-intervention
A single item, based on previous CRC screening research
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. There are no plans to share individual patient data.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carrie A Miller, PhD, MPH principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carrie A Miller, PhD, MPH ((804) 628-8188, carrie.a.miller@vcuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRC screening knowledge and awareness (time frame: 2-months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.