NCT05936931

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
17mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
3.1 years until next milestone

Study Start

First participant enrolled

July 31, 2026

Expected
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

June 23, 2023

Last Update Submit

April 14, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • CRC screening knowledge and awareness

    A composite index score on four awareness items and 14 knowledge items adopted from prior research

    2-months post-intervention

  • CRC screeningintentions

    A single item, based on previous CRC screening research

    2-months post-intervention

Study Arms (1)

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

Behavioral: Changes in CRC screening awareness and intentions

Interventions

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.

Aim 3: Single arm, open-label, pre-test/post-test design pilot trial

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Residents of counties in the Virginia/North Carolina CRC hotspot
  • 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)

You may not qualify if:

  • Participants in Aims 1 or 2 will be ineligible for Aim 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23289, United States

Location

Study Officials

  • Carrie A Miller, PhD, MPH

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carrie A Miller, PhD, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2023

First Posted

July 10, 2023

Study Start (Estimated)

July 31, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

There are no plans to share individual patient data.

Locations