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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21CA241637-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Colorado State University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Participants will be enrolled on a rolling basis and participate in SS for 4 weeks in the intervention condition. After pretesting, participants will receive sun protection messages from SS through emails/comments based on results from their activity data. All participants will complete posttest survey 4 weeks from randomization. |
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| Control Group | No Intervention | 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 weeks from randomization. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Physical Activity (Godin Leisure-Time Exercise Questionnaire) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Berteletti, MSW | Klein Buendel, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klein Buendel, Inc. | Golden | Colorado | 80401 | United States |
n=123 participants were recruited and screened for participation in formative research prior to the pilot study detailed, including focus groups, usability testing, and collection of activity data. None of those participants were randomized. n=41 participants participated in the randomized pilot as described in this entry.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | 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. 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. |
| FG001 | Control Group | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants are adults in the United States who exercise outdoor and use the Strava platform to log activity data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | proportion of practices/day | baseline and four-weeks post intervention |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julia Berteletti | Klein Buendel, Inc. | 303-565-4321 | jberteletti@kleinbuendel.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 22, 2020 | Sep 21, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 22, 2020 | Sep 21, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| BG001 | Control Group | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
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.
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.
| OG001 | Control Group | 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. |
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|
| 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. | Posted | Mean | Standard Deviation | sunburn | Baseline |
|
|
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| 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. | Posted | Mean | Standard Deviation | sunburn | four-weeks post intervention |
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| 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. | Posted | Mean | Standard Deviation | minutes | Baseline |
|
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| 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. | Posted | Mean | Standard Deviation | minutes | four-weeks post intervention |
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| 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. | Control group participants were not given this item. | Posted | Mean | Standard Deviation | units on a scale | four weeks post intervention |
|
|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and four-weeks post intervention |
|
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| 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. | Posted | Mean | Full Range | minutes | baseline |
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| 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. | Posted | Mean | Full Range | minutes | four weeks post-intervention |
|
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| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Control Group | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D001519 |
| Behavior |