Clinical trial NCT05618158: Cancer Prevention for Young Rural Adults
Official title: #4Corners4Health: A Social Media Cancer Prevention Program for Rural Emerging Adults
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cancer
Keywords: social media
cancer prevention
nicotine use
physical activity
nutrition
sun protection
alcohol use
HPV vaccine
media literacy
Lead sponsor: Klein Buendel, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
name: University of Arizona
name: University of Utah
name: Colorado State University
name: University of Colorado, Denver
name: University of New Mexico
First posted: 2022-11-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Randomized stepped-wedge with four cohorts
Primary purpose: PREVENTION

Brief summary: Young adults aged 18-26 engage in a number of behaviors that increase their risk of developing cancer later in life including sedentary lifestyles, unhealthy eating, nicotine produce us, heavy drinking of alcohol, increased UV exposure, and incomplete uptake of HPV vaccination. A multi-risk factor campaign will be developed to reduce these cancer risk behaviors and delivered to young adults over social media, a popular channel that can reach nearly all young adults. The campaign will be evaluated for effectiveness in a rigorous randomized trial with measures of moderate to vigorous physical activity, healthy eating patterns, nicotine product use, alcohol intake, sunburn prevalence, and HPV vaccination uptake.

Detailed description: Several risk factors are prevalent during early adulthood that can lead to cancer later in life. Emerging adults (EAs) aged 18-26 residing in rural areas of the United States engage in many cancer risk behaviors, especially sedentary lifestyles, poor eating patterns, nicotine product use, excess alcohol intake, infrequent sun protection, and inadequate uptake of the HPV vaccine. This application responds to RFA-CA-20-051, "Social and Behavioral Intervention Research to Address Modifiable Risk Factors for Cancer in Rural Populations." The goal is to improve cancer risk behavioral factors among diverse EAs aged 18-26 living in rural counties in the Four Corners states, a unique, underserved region, using a social media campaign designed with community advisors. EAs, including in rural communities, are heavy consumers of online content, especially over social media, and social media provide responsive, engaging, and low-cost platforms for distributing cancer prevention information with high dissemination potential. But, social media also circulate inaccurate, misleading, and harmful information. The specific aims of this research are to: 1) Develop a social media intervention for diverse EAs in rural communities via a community-engaged process that combines expert advice, user-generated content, and online instruction to communicate about behavioral cancer risks, cancer misinformation, counter marketing, digital and media literacy, and family communication; 2) evaluate the effect of a theory-based social media intervention on moderate to vigorous physical activity (MVPA), healthy eating patterns, nicotine product use, alcohol intake, sunburn prevalence, and HPV vaccination with the diverse population of EAs aged 18-26 in rural counties in AZ, CO, NM, and UT (Four Corners states) recruited from Qualtrics' survey panel and enrolled in a pragmatic randomized trial using a stepped-wedge design in which individual EAs will be randomized to 1 of 4 cohorts and receive the social media feed for varying durations in separate Facebook private groups; 3) test if improvements in EAs' cancer risk knowledge and beliefs, digital and media literacy skills, accurate cancer prevention information, and family communication mediate impact of the social media campaign; and 4) explore whether the impact of the social media campaign differs according to: a) level of EAs' engagement with campaign, b) cancer risk factors, and c) biological sex of the participants (as required by NIH). The research is innovative because it tests a theory-based, multi-risk factor approach to cancer prevention with diverse EAs in rural counties, an under-studied population, in a very popular new media. Social media may reach EAs more than interventions through other community channels (e.g., clinics, schools, and workplaces) and for lower cost in the geographically-dispersed, underserved rural communities in the Mountain West. The overall impact is extremely high because it will aid rural EAs in making informed decisions that reduce cancer risk factors and prevent cancer later in life and help EAs critically evaluate and resist misinformation and marketing that promote cancer risk behaviors.

Eligibility criteria: Inclusion Criteria:

* Aged 18-26 years old
* Resides in a county coded as RUCC 4-9 in Arizona, Colorado, New Mexico, or Utah
* Able to speak and read English
* Has regular social media engagement
* Accepts screening call from study staff
* Consents to participate

Exclusion Criteria:

* Participated in community engagement activities
* Cannot speak and read English
* Has low or no social media engagement
* Does not accept a screening call from study staff
* Does not consent to participate
* Does not give permission for engagement data to be extracted from Facebook private group
* If biologically female, currently pregnant

Primary outcomes:
measure: Physical Activity
timeFrame: Baseline
measure: Physical Activity
timeFrame: 3 months
measure: Physical Activity
timeFrame: 12 months
measure: Physical Activity
timeFrame: 24 months
measure: Diet
timeFrame: Baseline
measure: Diet
timeFrame: 3 months
measure: Diet
timeFrame: 12 months
measure: Diet
timeFrame: 24 months
measure: Nicotine Product Use
timeFrame: Baseline
measure: Nicotine Product Use
timeFrame: 3 months
measure: Nicotine Product Use
timeFrame: 12 months
measure: Nicotine Product Use
timeFrame: 24 months
measure: Alcohol Intake
timeFrame: Baseline
measure: Alcohol Intake
timeFrame: 3 months
measure: Alcohol Intake
timeFrame: 12 months
measure: Alcohol Intake
timeFrame: 24 months
measure: Uv Exposure
timeFrame: Baseline
measure: Uv Exposure
timeFrame: 3 months
measure: Uv Exposure
timeFrame: 12 months
measure: Uv Exposure
timeFrame: 24 months
measure: HPV Vaccination
timeFrame: Baseline
measure: HPV Vaccination
timeFrame: 3 months
measure: HPV Vaccination
timeFrame: 12 months
measure: HPV Vaccination
timeFrame: 24 months
Secondary outcomes:
measure: Physical Activity
timeFrame: Baseline
measure: Physical Activity
timeFrame: 3 months
measure: Physical Activity
timeFrame: 12 months
measure: Physical Activity
timeFrame: 24 months
measure: Diet
timeFrame: Baseline
measure: Diet
timeFrame: 3 months
measure: Diet
timeFrame: 12 months
measure: Diet
timeFrame: 24 months
measure: Nicotine Product Use
timeFrame: Baseline
measure: Nicotine Product Use
timeFrame: 3 months
measure: Nicotine Product Use
timeFrame: 12 months
measure: Nicotine Product Use
timeFrame: 24 months
measure: Nicotine Product Use
timeFrame: Baseline
measure: Nicotine Product Use
timeFrame: 3 months
measure: Nicotine Product Use
timeFrame: 12 months
measure: Nicotine Product Use
timeFrame: 24 months
measure: Alcohol Intake
timeFrame: Baseline
measure: Alcohol Intake
timeFrame: 3 months
measure: Alcohol Intake
timeFrame: 12 months
measure: Alcohol Intake
timeFrame: 24 months
measure: UV Exposure
timeFrame: Baseline
measure: UV Exposure
timeFrame: 3 months
measure: UV Exposure
timeFrame: 12 months
measure: UV Exposure
timeFrame: 24 months
measure: HPV Vaccination
timeFrame: Baseline
measure: HPV Vaccination
timeFrame: 3 months
measure: HPV Vaccination
timeFrame: 12 months
measure: HPV Vaccination
timeFrame: 24 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Klein Buendel, Inc.
name: David Buller, PhD
role: PRINCIPAL_INVESTIGATOR
References: