To hear about similar clinical trials, please enter your email below
Trial Title:
Rural Adult and Youth Sun Protection Study
NCT ID:
NCT06439979
Condition:
Melanoma (Skin)
Skin Cancer
Conditions: Official terms:
Melanoma
Skin Neoplasms
Conditions: Keywords:
Rural
Melanoma, Skin cancer
Prevention
Underserved communities
Youth
Sports
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
RAYS uses a 2-arm cluster-randomized trial in 2 rural US states (Utah and West Virginia)
matched for high skin cancer burden and rurality. This parallel model includes an
intervention arm, which will include sun-safety education and skin cancer prevention, and
the control arm which will focus on general sports-related injury prevention. Leagues
enrolled in the study will be randomized to one of the two arms.
Primary purpose:
Prevention
Masking:
Single (Participant)
Masking description:
Masking will only be used for participants in the study. Investigators will know which
arm of the study each participant has been randomized to.
Intervention:
Intervention type:
Behavioral
Intervention name:
RAYS Intervention
Description:
Developmental baseball leagues will be randomly assigned to RAYS vs. control. Outcomes
include directly-observed child sun safety behaviors after controlling for environmental
ultra-violet radiation (UVR), with parent-reported child sun protection and other related
endpoints at 1 year.
Arm group label:
RAYS Intervention
Summary:
The purpose of this study is to help prevent skin cancer by improving the use of sun
protective behaviors among youths living in rural communities in Utah and West Virginia.
Detailed description:
Children living in rural and under-served communities are at high risk for skin cancer;
however, there are no evidence-based sun safety interventions showing durable effects for
this vulnerable pediatric population. The objective of this proposal is to rigorously
test a novel, multi-level approach to skin cancer prevention among young rural children
that is delivered through developmental baseball leagues. To attain this objective, the
investigators will conduct a two-arm cluster-randomized trial with the primary outcome
being multi-behavior sun protection change among children.
Criteria for eligibility:
Criteria:
Parent inclusion criteria:
i. Adults who currently have children ages 3 and older years of age playing on
participating sports teams in leagues serving rural areas in Utah or West Virginia (rural
is defined as ≥4 by the RUCA or RUCC systems)
ii. Live and/or work in rural communities in Utah or West Virginia (≥4 as defined by the
RUCA or RUCC systems)
Coach/leader inclusion criteria:
i. Adults who serve as coaches or leaders of recreational sports (i.e. baseball/softball,
soccer, flag football, etc.) teams or developmental programs serving children ages 3 and
older
ii. Live and/or work in rural areas of Utah or West Virginia (rural is defined as ≥4 by
the RUCA or RUCC systems)
Participant inclusion criteria for minor participants (ages 3 and older) are as follows:
i. Live in rural communities and/or participate in sports leagues serving rural
communities in Utah or West Virginia (≥4 as defined by the RUCA or RUCC systems).
Participant inclusion criteria for key informant interviews are as follows:
i. Adults who serve as leaders or who are affiliated with sports leagues or community
groups serving rural youths and/or adults who currently have minor children 3 years of
age or older playing on participating sports teams and/or adults who live and/or work in
rural communities in Utah or West Virginia ((≥4 as defined by the RUCA or RUCC systems)
Local sports leagues will be eligible to participate if they convene recreational sports
(i.e. baseball/softball) teams or developmental programs (i.e. T-ball and coach pitch)
for children ages 3 and older.
Exclusion Criteria:
- Adults and children who do not speak or read English will be excluded.
- For individuals asked to complete surveys, individuals who have a medical or other
condition (e.g., developmental delay) that would preclude their completion of these
surveys will be excluded.
Gender:
All
Minimum age:
3 Years
Maximum age:
7 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University of Utah
Address:
City:
Salt Lake City
Zip:
84132
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yelena P Wu, PhD
Phone:
801-585-0303
Email:
yelena.wu@utah.edu
Contact backup:
Last name:
Kate M Welch, BS
Phone:
8015850303
Email:
kate.welch@hci.utah.edu
Investigator:
Last name:
Yelena P Wu, PhD
Email:
Principal Investigator
Facility:
Name:
West Virginia University
Address:
City:
Morgantown
Zip:
26501
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Dannell Boatman, MS
Phone:
304-293-8409
Email:
dboatman@hsc.wvu.edu
Contact backup:
Last name:
Zack Jarrett, MS
Phone:
304-293-8409
Email:
rays-wv@hsc.wvu.edu
Investigator:
Last name:
Dannell Boatman, MS
Email:
Principal Investigator
Investigator:
Last name:
Zack Jarrett, MS
Email:
Sub-Investigator
Start date:
April 8, 2024
Completion date:
April 2030
Lead sponsor:
Agency:
University of Utah
Agency class:
Other
Collaborator:
Agency:
Georgetown University
Agency class:
Other
Collaborator:
Agency:
West Virginia University
Agency class:
Other
Source:
University of Utah
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06439979
