Cancer Prevention for Young Rural Adults

Sponsor
Klein Buendel, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05618158
Collaborator
National Cancer Institute (NCI) (NIH), University of Arizona (Other), University of Utah (Other), Colorado State University (Other), University of Colorado, Denver (Other), University of New Mexico (Other)
1,000
5
1
48
200
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: 4 Corners Rural Health Cancer Prevention
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Randomized stepped-wedge with four cohortsRandomized stepped-wedge with four cohorts
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
#4Corners4Health: A Social Media Cancer Prevention Program for Rural Emerging Adults
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Nov 30, 2026
Anticipated Study Completion Date :
Feb 28, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: 4 Corners Rural Cancer Prevention

Four separate Facebook groups, which provide information via posts within the private groups about cancer risk factors (e.g. reducing alcohol consumption, tobacco use cessation, increasing physical activity), behavioral skills to reduce them, benefits of, social support for, and ways to reduce social/financial costs of cancer prevention, and advice from health care providers to decrease barriers. Posts will seek to improve self- and response-efficacy and perceived risk, and link cancer prevention to personal goals.

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.

Outcome Measures

Primary Outcome Measures

  1. Physical Activity [Baseline]

    Participants will self-report minutes per week of moderate to vigorous physical activity.

  2. Physical Activity [3 months]

    Participants will self-report minutes per week of moderate to vigorous physical activity.

  3. Physical Activity [12 months]

    Participants will self-report minutes per week of moderate to vigorous physical activity.

  4. Physical Activity [24 months]

    Participants will self-report minutes per week of moderate to vigorous physical activity.

  5. Diet [Baseline]

    Participants will self-report intake per day of fruits, vegetables, whole grains/fiber, added sugars (from sugar-sweetened beverages), and red/processed meats.

  6. Diet [3 months]

    Participants will self-report intake per day of fruits, vegetables, whole grains/fiber, added sugars (from sugar-sweetened beverages), and red/processed meats.

  7. Diet [12 months]

    Participants will self-report intake per day of fruits, vegetables, whole grains/fiber, added sugars (from sugar-sweetened beverages), and red/processed meats.

  8. Diet [24 months]

    Participants will self-report intake per day of fruits, vegetables, whole grains/fiber, added sugars (from sugar-sweetened beverages), and red/processed meats.

  9. Nicotine Product Use [Baseline]

    Participants will self-report tobacco/nicotine use in the past 30 days (every day, some days, not at all).

  10. Nicotine Product Use [3 months]

    Participants will self-report tobacco/nicotine use in the past 30 days (every day, some days, not at all).

  11. Nicotine Product Use [12 months]

    Participants will self-report tobacco/nicotine use in the past 30 days (every day, some days, not at all).

  12. Nicotine Product Use [24 months]

    Participants will self-report tobacco/nicotine use in the past 30 days (every day, some days, not at all).

  13. Alcohol Intake [Baseline]

    Participants self-report consumption of number of alcoholic drinks in the past 30 days.

  14. Alcohol Intake [3 months]

    Participants self-report consumption of number of alcoholic drinks in the past 30 days.

  15. Alcohol Intake [12 months]

    Participants self-report consumption of number of alcoholic drinks in the past 30 days.

  16. Alcohol Intake [24 months]

    Participants self-report consumption of number of alcoholic drinks in the past 30 days.

  17. Uv Exposure [Baseline]

    Participants will self-report number of sunburns.

  18. Uv Exposure [3 months]

    Participants will self-report number of sunburns.

  19. Uv Exposure [12 months]

    Participants will self-report number of sunburns.

  20. Uv Exposure [24 months]

    Participants will self-report number of sunburns.

  21. HPV Vaccination [Baseline]

    Participants will self-report whether or not they have received one or more doses of the HPV vaccine.

  22. HPV Vaccination [3 months]

    Participants will self-report whether or not they have received one or more doses of the HPV vaccine.

  23. HPV Vaccination [12 months]

    Participants will self-report whether or not they have received one or more doses of the HPV vaccine.

  24. HPV Vaccination [24 months]

    Participants will self-report whether or not they have received one or more doses of the HPV vaccine.

Secondary Outcome Measures

  1. Physical Activity [Baseline]

    Participants will self-report number of minutes per week engaging in physical activity to determine if they meet the 150 minutes per week recommendation.

  2. Physical Activity [3 months]

    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. Physical Activity [12 months]

    Participants will self-report number of minutes per week engaging in physical activity to determine if they meet the 150 minutes per week recommendation.

  4. Physical Activity [24 months]

    Participants will self-report number of minutes per week engaging in physical activity to determine if they meet the 150 minutes per week recommendation.

  5. Diet [Baseline]

    Participants will self-report frequency of eating meals away from home/fast food.

  6. Diet [3 months]

    Participants will self-report frequency of eating meals away from home/fast food.

  7. Diet [12 months]

    Participants will self-report frequency of eating meals away from home/fast food.

  8. Diet [24 months]

    Participants will self-report frequency of eating meals away from home/fast food.

  9. Nicotine Product Use [Baseline]

    Participants will self-report tobacco/nicotine use in the past 7 days (every day, some days, not at all).

  10. Nicotine Product Use [3 months]

    Participants will self-report tobacco/nicotine use in the past 7 days (every day, some days, not at all).

  11. Nicotine Product Use [12 months]

    Participants will self-report tobacco/nicotine use in the past 7 days (every day, some days, not at all).

  12. Nicotine Product Use [24 months]

    Participants will self-report tobacco/nicotine use in the past 7 days (every day, some days, not at all).

  13. Nicotine Product Use [Baseline]

    Participants will self-report readiness to quit using a 10 point rating scale (1=no thought of quitting; 10=taking action to quit).

  14. Nicotine Product Use [3 months]

    Participants will self-report readiness to quit using a 10 point rating scale (1=no thought of quitting; 10=taking action to quit).

  15. Nicotine Product Use [12 months]

    Participants will self-report readiness to quit using a 10 point rating scale (1=no thought of quitting; 10=taking action to quit).

  16. Nicotine Product Use [24 months]

    Participants will self-report readiness to quit using a 10 point rating scale (1=no thought of quitting; 10=taking action to quit).

  17. Alcohol Intake [Baseline]

    Participants will self-report number of times binge drinking in the past 30 days.

  18. Alcohol Intake [3 months]

    Participants will self-report number of times binge drinking in the past 30 days.

  19. Alcohol Intake [12 months]

    Participants will self-report number of times binge drinking in the past 30 days.

  20. Alcohol Intake [24 months]

    Participants will self-report number of times binge drinking in the past 30 days.

  21. UV Exposure [Baseline]

    Participants will self-report sun protection behaviors with percent of sun exposure hours using sun protection.

  22. UV Exposure [3 months]

    Participants will self-report sun protection behaviors with percent of sun exposure hours using sun protection.

  23. UV Exposure [12 months]

    Participants will self-report sun protection behaviors with percent of sun exposure hours using sun protection.

  24. UV Exposure [24 months]

    Participants will self-report sun protection behaviors with percent of sun exposure hours using sun protection.

  25. HPV Vaccination [Baseline]

    Participants will self-report if they have completed the series of HPV vaccination by receiving 3 doses of the vaccine.

  26. HPV Vaccination [3 months]

    Participants will self-report if they have completed the series of HPV vaccination by receiving 3 doses of the vaccine.

  27. HPV Vaccination [12 months]

    Participants will self-report if they have completed the series of HPV vaccination by receiving 3 doses of the vaccine.

  28. HPV Vaccination [24 months]

    Participants will self-report if they have completed the series of HPV vaccination by receiving 3 doses of the vaccine.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 26 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Arizona Tucson Arizona United States 85719
2 University of Colorado Denver Aurora Colorado United States 80045-2570
3 Colorado State University Fort Collins Colorado United States 80521-4593
4 University of New Mexico Albuquerque New Mexico United States 87131-0001
5 University of Utah Salt Lake City Utah United States 84112-5550

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: David Buller, PhD, Klein Buendel, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Klein Buendel, Inc.
ClinicalTrials.gov Identifier:
NCT05618158
Other Study ID Numbers:
  • 0341
  • 1R01CA268037-01A1
First Posted:
Nov 16, 2022
Last Update Posted:
Nov 16, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Klein Buendel, Inc.

Study Results

No Results Posted as of Nov 16, 2022