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Trial Title: Cancer Prevention for Young Rural Adults

NCT ID: NCT05618158

Condition: Cancer

Conditions: Keywords:
social media
cancer prevention
nicotine use
physical activity
nutrition
sun protection
alcohol use
HPV vaccine
media literacy

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Randomized stepped-wedge with four cohorts

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: 4 Corners Rural Health Cancer Prevention
Description: Participants, aged 18-26, will join a private Facebook group to participate in the intervention. The group is not viewable to the public, including other Facebook users. Content that focuses on cancer prevention behaviors will be posted twice per day for up to 12 months. Each group will be hosted by a moderator who is responsible for managing the intervention goals and participants' engagement.
Arm group label: 4 Corners Rural Cancer Prevention

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 26 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: University of Arizona

Address:
City: Tucson
Zip: 85719
Country: United States

Facility:
Name: University of Colorado Denver

Address:
City: Aurora
Zip: 80045-2570
Country: United States

Facility:
Name: Colorado State University

Address:
City: Fort Collins
Zip: 80521-4593
Country: United States

Facility:
Name: University of New Mexico

Address:
City: Albuquerque
Zip: 87131-0001
Country: United States

Facility:
Name: University of Utah

Address:
City: Salt Lake City
Zip: 84112-5550
Country: United States

Start date: April 20, 2024

Completion date: August 31, 2027

Lead sponsor:
Agency: Klein Buendel, Inc.
Agency class: Industry

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Collaborator:
Agency: University of Arizona
Agency class: Other

Collaborator:
Agency: University of Utah
Agency class: Other

Collaborator:
Agency: Colorado State University
Agency class: Other

Collaborator:
Agency: University of Colorado, Denver
Agency class: Other

Collaborator:
Agency: University of New Mexico
Agency class: Other

Source: Klein Buendel, Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05618158

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