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Using Physical Tracking to Predict Sunburn

Primary Purpose

Prevention

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention Group
Sponsored by
Klein Buendel, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention focused on measuring skin cancer, physical activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 or older; reside in the United States; read/write in English; upload outdoor activity to Strava ≥3 times per week

Exclusion Criteria:

  • Younger than 18; reside outside of the United States; read/write in a language other than English; uploads Strava activity less than 3 times per week OR does not use Strava; having a cognitive or visual impairment that would interfere with participating; having another family member participating in the research; having participated in the focus group and usability testing

Sites / Locations

  • Klein Buendel, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Participants will be enrolled on a rolling basis and participate in SS for 4 months in the intervention condition. After pretesting, participants will receive sun protection messages from SS through emails/comments based on algorithm results from their profile and activity data. All participants will complete posttest survey 4 months from randomization.

A small control group will be included to see if a no-treatment control condition is acceptable to users and estimate follow-up rates for planning a randomized trial. Participants will be enrolled on a rolling basis and will complete a pretest at randomization. All participants will complete a posttest survey 4 months from randomization.

Outcomes

Primary Outcome Measures

Frequency of Using Sun Protection Practices
What proportion of 8 sun protection practices did participants do on reported days of exercise. Results were calculated by summing sun protection practices done and dividing by the number of days they reported exercise times the total number of potential practices assessed. Range = 0-100%
Prevalence of Sunburn
Participants were asked if their skin was sunburned (described as being red and/or painful from exposure to the sun) in the past three months, and if so, how many times.
Prevalence of Sunburn
Participants were asked if their skin was sunburned (described as being red and/or painful from exposure to the sun) in the past four weeks, and if so, how many times.

Secondary Outcome Measures

Physical Activity (Godin Leisure-Time Exercise Questionnaire)
Duration in minutes of exercise multiplied by number of times per week, in the past 7 days. Total minutes per week calculated; mean per treatment group reported. Range = 36-2580 minutes.
Physical Activity (Godin Leisure-Time Exercise Questionnaire)
Duration in minutes of exercise multiplied by number of times per week, in the past 7 days. Total minutes per week calculated; mean per treatment group reported. Range = 0-2220 minutes.
Recall of Sun Protection Messages
Participants in intervention only were asked about how many messages they read. Scale ranges from 0 - 3. 0 = none of the messages; 1 = some of the messages; 2 = most of the messages; 3 = all of the messages. Higher score indicates higher message recall.
Self-Efficacy for Sun Protection When Exercising
Participants were asked: how confident are you that you can practice sun safety next time that you exercise. 1 = not confident; 2 = a little confident; 3 = somewhat confident; 4 = very confident. Higher scores indicates more self-efficacy for sun safety.

Full Information

First Posted
July 2, 2021
Last Updated
September 21, 2023
Sponsor
Klein Buendel, Inc.
Collaborators
National Cancer Institute (NCI), Colorado State University
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1. Study Identification

Unique Protocol Identification Number
NCT04977700
Brief Title
Using Physical Tracking to Predict Sunburn
Official Title
Using Retrospective and Real-Time Physical Activity Tracking to Predict Risk of Sunburn in Outdoor Exercisers on Strava
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 6, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Klein Buendel, Inc.
Collaborators
National Cancer Institute (NCI), Colorado State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Recreational UV exposure is associated with every form of skin cancer and individuals who engage in more physical activity have a higher prevalence of sunburn, a proximal biomarker of melanoma risk, perhaps explaining why melanoma is the only cancer with which physical activity is positively correlated. Mobile technology for tracking physical activity has become increasingly prevalent and Strava, an activity tracking app and social networking site for athletes, is one of the most popular of these technologies. This research will test the feasibility of delivering location-based, ecologically-valid sun safety advice to Strava users at times when they are predicted to be engaged in outdoor physical activity, by utilizing Strava's public open-source Applications Programming Interface.
Detailed Description
Skin cancer is the most common cancer in the United States. Over 5.4 million cases of keratinocyte cancers (basal and squamous cell) are diagnosed annually and incidence of melanoma has increased 3% each year for the past 30 years. In the 2014 Call to Action to Prevent Skin Cancer, the U. S. Surgeon General included strategies for coordinating messages on sun safety and physical activity, recognizing the need for sun safety among populations that engage in physical activity outdoors. Recreational UV exposure is associated with every form of skin cancer; individuals who engage in more physical activity have a higher prevalence of sunburn. Melanoma is the only cancer with which physical activity is positively correlated. Strava, a tracking app and social networking site for athletes, is one of the most popular of mobile technologies for logging physical activity and providing social feedback on activities by other Strava users. The goal of this R21 research is to test the feasibility of interfacing with the Strava website and its mobile app to develop an algorithm that a) predicts when individuals are likely to be engaged in physical activity outdoors in the sun when ultraviolet radiation is high and b) delivers sun safety advice tailored to the time, location, and personal risk (e.g., skin sun sensitivity) of the Strava users. Concept focus groups with Strava users (n=16) and non-users (n=16) will provide input on the feasibility, content, and functions in the Strava Sun (SS) intervention. The algorithm that predicts future outdoor exercise will be developed using machine learning modeling on activity data provided by Strava users (n=1000). The SS intervention will be programmed to deliver ecologically-valid sun safety advice through Strava's open-source Applications Programming Interface (API) via email and comments in the Strava interface. The sun safety advice will be tailored to location, time, season and user's personal risk, employing advice algorithms we developed for a sun safety mobile app, sunZapp, and a social media message library in our Go Sun Smart intervention for outdoor recreation resorts. SS will be tested for usability (n=30 Strava users) prior to conducting a pilot field trial to establish feasibility of SS in practice (n=226 Strava users). The project is significant and innovative. A sun protection interface for the Strava platform will provide individuals who engage in regular physical activity personalized, ecologically-valid advice to help them practice sun safety during outdoor activities. It will contain a novel machine learning algorithm that predicts future high-risk behavior, i.e., outdoor physical activity, to provide precision prevention advice. The intervention will be delivered over an established and popular technology platform with over 42 million registered users.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention
Keywords
skin cancer, physical activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Participants will be enrolled on a rolling basis and participate in SS for 4 months in the intervention condition. After pretesting, participants will receive sun protection messages from SS through emails/comments based on algorithm results from their profile and activity data. All participants will complete posttest survey 4 months from randomization.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
A small control group will be included to see if a no-treatment control condition is acceptable to users and estimate follow-up rates for planning a randomized trial. Participants will be enrolled on a rolling basis and will complete a pretest at randomization. All participants will complete a posttest survey 4 months from randomization.
Intervention Type
Behavioral
Intervention Name(s)
Intervention Group
Intervention Description
Test the developed algorithm that delivers location-based, tailored sun safety advice to Strava users through Strava comments for acceptability, ways of interacting with it, and barriers/willingness to allowing access.
Primary Outcome Measure Information:
Title
Frequency of Using Sun Protection Practices
Description
What proportion of 8 sun protection practices did participants do on reported days of exercise. Results were calculated by summing sun protection practices done and dividing by the number of days they reported exercise times the total number of potential practices assessed. Range = 0-100%
Time Frame
baseline and four-weeks post intervention
Title
Prevalence of Sunburn
Description
Participants were asked if their skin was sunburned (described as being red and/or painful from exposure to the sun) in the past three months, and if so, how many times.
Time Frame
Baseline
Title
Prevalence of Sunburn
Description
Participants were asked if their skin was sunburned (described as being red and/or painful from exposure to the sun) in the past four weeks, and if so, how many times.
Time Frame
four-weeks post intervention
Secondary Outcome Measure Information:
Title
Physical Activity (Godin Leisure-Time Exercise Questionnaire)
Description
Duration in minutes of exercise multiplied by number of times per week, in the past 7 days. Total minutes per week calculated; mean per treatment group reported. Range = 36-2580 minutes.
Time Frame
Baseline
Title
Physical Activity (Godin Leisure-Time Exercise Questionnaire)
Description
Duration in minutes of exercise multiplied by number of times per week, in the past 7 days. Total minutes per week calculated; mean per treatment group reported. Range = 0-2220 minutes.
Time Frame
four-weeks post intervention
Title
Recall of Sun Protection Messages
Description
Participants in intervention only were asked about how many messages they read. Scale ranges from 0 - 3. 0 = none of the messages; 1 = some of the messages; 2 = most of the messages; 3 = all of the messages. Higher score indicates higher message recall.
Time Frame
4 weeks post intervention
Title
Self-Efficacy for Sun Protection When Exercising
Description
Participants were asked: how confident are you that you can practice sun safety next time that you exercise. 1 = not confident; 2 = a little confident; 3 = somewhat confident; 4 = very confident. Higher scores indicates more self-efficacy for sun safety.
Time Frame
baseline and four-weeks post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 or older; reside in the United States; read/write in English; upload outdoor activity to Strava ≥3 times per week Exclusion Criteria: Younger than 18; reside outside of the United States; read/write in a language other than English; uploads Strava activity less than 3 times per week OR does not use Strava; having a cognitive or visual impairment that would interfere with participating; having another family member participating in the research; having participated in the focus group and usability testing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Berteletti, MSW
Organizational Affiliation
Klein Buendel, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klein Buendel, Inc.
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States

12. IPD Sharing Statement

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Using Physical Tracking to Predict Sunburn

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