Cancer Prevention for Young Rural Adults

Cancer Clinical Trial

Official title:

#4Corners4Health: A Social Media Cancer Prevention Program for Rural Emerging Adults

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05618158
• Other study ID #: 0341
• Secondary ID: 1R01CA268037-01A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 20, 2024
• Est. completion date: February 28, 2027

Study information

• Verified date: May 2024
• Source: Klein Buendel, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: February 28, 2027
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• 4 Corners Rural Health Cancer Prevention
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.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	University of Colorado Denver	Aurora	Colorado
United States	Colorado State University	Fort Collins	Colorado
United States	University of Utah	Salt Lake City	Utah
United States	University of Arizona	Tucson	Arizona

Sponsors (7)

Lead Sponsor	Collaborator
Klein Buendel, Inc.	Colorado State University, National Cancer Institute (NCI), University of Arizona, University of Colorado, Denver, University of New Mexico, University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity	Participants will self-report minutes per week of moderate to vigorous physical activity.	Baseline
Primary	Physical Activity	Participants will self-report minutes per week of moderate to vigorous physical activity.	3 months
Primary	Physical Activity	Participants will self-report minutes per week of moderate to vigorous physical activity.	12 months
Primary	Physical Activity	Participants will self-report minutes per week of moderate to vigorous physical activity.	24 months
Primary	Diet	Participants will self-report intake per day of fruits, vegetables, whole grains/fiber, added sugars (from sugar-sweetened beverages), and red/processed meats.	Baseline
Primary	Diet	Participants will self-report intake per day of fruits, vegetables, whole grains/fiber, added sugars (from sugar-sweetened beverages), and red/processed meats.	3 months
Primary	Diet	Participants will self-report intake per day of fruits, vegetables, whole grains/fiber, added sugars (from sugar-sweetened beverages), and red/processed meats.	12 months
Primary	Diet	Participants will self-report intake per day of fruits, vegetables, whole grains/fiber, added sugars (from sugar-sweetened beverages), and red/processed meats.	24 months
Primary	Nicotine Product Use	Participants will self-report tobacco/nicotine use in the past 30 days (every day, some days, not at all).	Baseline
Primary	Nicotine Product Use	Participants will self-report tobacco/nicotine use in the past 30 days (every day, some days, not at all).	3 months
Primary	Nicotine Product Use	Participants will self-report tobacco/nicotine use in the past 30 days (every day, some days, not at all).	12 months
Primary	Nicotine Product Use	Participants will self-report tobacco/nicotine use in the past 30 days (every day, some days, not at all).	24 months
Primary	Alcohol Intake	Participants self-report consumption of number of alcoholic drinks in the past 30 days.	Baseline
Primary	Alcohol Intake	Participants self-report consumption of number of alcoholic drinks in the past 30 days.	3 months
Primary	Alcohol Intake	Participants self-report consumption of number of alcoholic drinks in the past 30 days.	12 months
Primary	Alcohol Intake	Participants self-report consumption of number of alcoholic drinks in the past 30 days.	24 months
Primary	Uv Exposure	Participants will self-report number of sunburns.	Baseline
Primary	Uv Exposure	Participants will self-report number of sunburns.	3 months
Primary	Uv Exposure	Participants will self-report number of sunburns.	12 months
Primary	Uv Exposure	Participants will self-report number of sunburns.	24 months
Primary	HPV Vaccination	Participants will self-report whether or not they have received one or more doses of the HPV vaccine.	Baseline
Primary	HPV Vaccination	Participants will self-report whether or not they have received one or more doses of the HPV vaccine.	3 months
Primary	HPV Vaccination	Participants will self-report whether or not they have received one or more doses of the HPV vaccine.	12 months
Primary	HPV Vaccination	Participants will self-report whether or not they have received one or more doses of the HPV vaccine.	24 months
Secondary	Physical Activity	Participants will self-report number of minutes per week engaging in physical activity to determine if they meet the 150 minutes per week recommendation.	Baseline
Secondary	Physical Activity	Participants will self-report number of minutes per week engaging in physical activity to determine if they meet the 150 minutes per week recommendation.	3 months
Secondary	Physical Activity	Participants will self-report number of minutes per week engaging in physical activity to determine if they meet the 150 minutes per week recommendation.	12 months
Secondary	Physical Activity	Participants will self-report number of minutes per week engaging in physical activity to determine if they meet the 150 minutes per week recommendation.	24 months
Secondary	Diet	Participants will self-report frequency of eating meals away from home/fast food.	Baseline
Secondary	Diet	Participants will self-report frequency of eating meals away from home/fast food.	3 months
Secondary	Diet	Participants will self-report frequency of eating meals away from home/fast food.	12 months
Secondary	Diet	Participants will self-report frequency of eating meals away from home/fast food.	24 months
Secondary	Nicotine Product Use	Participants will self-report tobacco/nicotine use in the past 7 days (every day, some days, not at all).	Baseline
Secondary	Nicotine Product Use	Participants will self-report tobacco/nicotine use in the past 7 days (every day, some days, not at all).	3 months
Secondary	Nicotine Product Use	Participants will self-report tobacco/nicotine use in the past 7 days (every day, some days, not at all).	12 months
Secondary	Nicotine Product Use	Participants will self-report tobacco/nicotine use in the past 7 days (every day, some days, not at all).	24 months
Secondary	Nicotine Product Use	Participants will self-report readiness to quit using a 10 point rating scale (1=no thought of quitting; 10=taking action to quit).	Baseline
Secondary	Nicotine Product Use	Participants will self-report readiness to quit using a 10 point rating scale (1=no thought of quitting; 10=taking action to quit).	3 months
Secondary	Nicotine Product Use	Participants will self-report readiness to quit using a 10 point rating scale (1=no thought of quitting; 10=taking action to quit).	12 months
Secondary	Nicotine Product Use	Participants will self-report readiness to quit using a 10 point rating scale (1=no thought of quitting; 10=taking action to quit).	24 months
Secondary	Alcohol Intake	Participants will self-report number of times binge drinking in the past 30 days.	Baseline
Secondary	Alcohol Intake	Participants will self-report number of times binge drinking in the past 30 days.	3 months
Secondary	Alcohol Intake	Participants will self-report number of times binge drinking in the past 30 days.	12 months
Secondary	Alcohol Intake	Participants will self-report number of times binge drinking in the past 30 days.	24 months
Secondary	UV Exposure	Participants will self-report sun protection behaviors with percent of sun exposure hours using sun protection.	Baseline
Secondary	UV Exposure	Participants will self-report sun protection behaviors with percent of sun exposure hours using sun protection.	3 months
Secondary	UV Exposure	Participants will self-report sun protection behaviors with percent of sun exposure hours using sun protection.	12 months
Secondary	UV Exposure	Participants will self-report sun protection behaviors with percent of sun exposure hours using sun protection.	24 months
Secondary	HPV Vaccination	Participants will self-report if they have completed the series of HPV vaccination by receiving 3 doses of the vaccine.	Baseline
Secondary	HPV Vaccination	Participants will self-report if they have completed the series of HPV vaccination by receiving 3 doses of the vaccine.	3 months
Secondary	HPV Vaccination	Participants will self-report if they have completed the series of HPV vaccination by receiving 3 doses of the vaccine.	12 months
Secondary	HPV Vaccination	Participants will self-report if they have completed the series of HPV vaccination by receiving 3 doses of the vaccine.	24 months