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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04977700
Other study ID # 0328
Secondary ID 1R21CA241637-01A
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date June 30, 2023

Study information

Verified date November 2023
Source Klein Buendel, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 and non-users 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. 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 prior to conducting a pilot field trial to establish feasibility of SS in practice. 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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Intervention Group
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.

Locations

Country Name City State
United States Klein Buendel, Inc. Golden Colorado

Sponsors (3)

Lead Sponsor Collaborator
Klein Buendel, Inc. Colorado State University, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of Sun Protection Practices What proportion of 8 sun protection practices did participants do on reported days of exercise. Participants responded to 8 potential sun protection practices and provided the number of days they did each practice within the timeframe provided (3 months at baseline; 4 weeks at posttest). Participants also provided number of days of outdoor exercises within timeframe. Proportion was calculated by dividing the frequency of each sun protection practice by the number of days of outdoor exercise within the timeframe. Mean score of all sun protection practices per day of outdoor exercise is reported. Range = 0-1, where a higher number indicates more sun safety practices performed. A proportion was used to account for different timeframes at baseline and posttest. baseline and four-weeks post intervention
Primary 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. Baseline
Primary 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. four-weeks post intervention
Secondary 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. Baseline
Secondary 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. four-weeks post intervention
Secondary 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. four weeks post intervention
Secondary 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. baseline and four-weeks post intervention
Secondary Range of 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. baseline
Secondary Range of 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. four weeks post-intervention
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