An interventional study of Intervention Group in Prevention, sponsored by Klein Buendel, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by Klein Buendel, Inc. · Not applicable, Interventional, and Prevention
Among 379 studies in Skin Neoplasms with a site in United States — 62 open to participants now, 96 under way, 7 of them phase 3. Skin Neoplasms · United States.
Among the 379 studies in Skin Neoplasms with a site in United States, this one is the 147th largest by enrollment of the 288 interventional ones that give a count, is one of 26 that started in 2020, is one of 96 with no phase, and was the 279th registered.
604 studies on the registry are indexed under Skin Neoplasms; 126 are open to participants now.
Browse Skin Neoplasms studies →62 of the 379 studies in Skin Neoplasms with a site in United States are open now. Recruiting first, the newest first:
Vanderbilt-Ingram Cancer Center · Sites in United States
Ages 18+
Rutgers, The State University of New Jersey · Sites in United States
Ages 13+ · Healthy volunteers
University of Utah · Sites in United States
Ages 18–29 · Healthy volunteers
Marissa Lobl · Sites in United States
Ages 18+
Dana-Farber Cancer Institute · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 104 Skin Neoplasms studies recruiting now, 84 (81%) set no upper age limit and 9 (9%) stop at 75 or younger; 15 take children under 18; 25 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
379 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 84 · Phase 2 114 · Phase 3 26 · Phase 4 11
First in 1977; this study’s year is marked. 26 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 41 is below the median of 55 across 408 interventional studies indexed under Skin Neoplasms.
Median enrollment 44 across the 288 interventional studies, 149 across the 80 observational. Of the 258 that completed or were terminated, 92 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
107 of 379 have an industry lead sponsor. The 10 most frequent:
Klein Buendel, Inc. is the lead sponsor of 35 studies on the registry; 2 are open to participants now.
Klein Buendel, Inc. has 9 studies filed under Skin Neoplasms — fewer than ten, so there is no comparison to draw.
33 of the studies in Skin Neoplasms with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05608291Phase 3Regeneron PharmaceuticalsA Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery | 2027-01-15 |
| NCT06947928Phase 3TuHURA Biosciences, Inc.Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma | 2027-03-31 |
| NCT05634252Phase 3University of UtahUndergraduate Skin Cancer Prevention Trial | 2027-09-04 |
| NCT07201376Dartmouth-Hitchcock Medical CenterAssessment of Skin Lesions Using a Tissue Oxygen Imager Based on Protoporphyrin IX (PPIX) Fluorescence. This is an Open-label, Non-randomized, Feasibility Study That Includes a One-time Application of an FDA Approved Medication Followed by Local Imaging for Benign Skin Growth and Lesions Clinically | 2026-11 |
| NCT06608511University of Wisconsin, MadisonLiquid Biomarker Study in Melanoma and Non-Melanoma Skin Cancers | 2026-12 |
Among the 379 studies in Skin Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Intervention 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 weeks from randomization.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: four-weeks post intervention
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.
Time frame: Baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: four weeks post-intervention
| Milestone | Intervention Group | Control Group |
|---|---|---|
| Started | 31 | 10 |
| Completed | 31 | 10 |
| Not completed | 0 | 0 |
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.
| proportion of practices/day | Intervention Group | Control Group |
|---|---|---|
| baseline | 0.30 ± 0.35 | 0.43 ± 0.43 |
| four week posttest | 0.35 ± 0.37 | 0.41 ± 0.45 |
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.
| sunburn | Intervention Group | Control Group |
|---|---|---|
| Prevalence of Sunburn | 1.0 ± 2.7 | 0.2 ± 0.6 |
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.
| sunburn | Intervention Group | Control Group |
|---|---|---|
| Prevalence of Sunburn | 0.3 ± 0.6 | 0.3 ± 0.7 |
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.
| minutes | Intervention Group | Control Group |
|---|---|---|
| Physical Activity (Godin Leisure-Time Exercise Questionnaire) | 578.1 ± 603.3 | 465.8 ± 250.4 |
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.
| minutes | Intervention Group | Control Group |
|---|---|---|
| Physical Activity (Godin Leisure-Time Exercise Questionnaire) | 474.6 ± 238.4 | 657.5 ± 578.0 |
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.
| units on a scale | Intervention Group | Control Group |
|---|---|---|
| Recall of Sun Protection Messages | 1.9 ± 1.0 | — |
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.
| units on a scale | Intervention Group | Control Group |
|---|---|---|
| baseline | 3.1 ± 0.9 | 3.4 ± 0.8 |
| four-week follow-up | 3.4 ± 0.8 | 3.3 ± 0.5 |
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.
| minutes | Intervention Group | Control Group |
|---|---|---|
| Range of Physical Activity (Godin Leisure-Time Exercise Questionnaire) | 578.1 (36 to 2580) | 465.8 (138 to 960) |
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.
| minutes | Intervention Group | Control Group |
|---|---|---|
| Range of Physical Activity (Godin Leisure-Time Exercise Questionnaire) | 474.6 (0 to 1020) | 657.5 (285 to 2220) |
Collected over 4 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Control Group | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
Participants are adults in the United States who exercise outdoor and use the Strava platform to log activity data.
| Age, Categorical(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 28 | 7 | 35 |
| >=65 years | 3 | 3 | 6 |
| Age, Continuous(years) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Mean | 42.2 ± 14.8 | 48.9 ± 17.9 | 43.9 ± 15.7 |
| Sex: Female, Male(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Female | 22 | 7 | 29 |
| Male | 9 | 3 | 12 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 31 | 9 | 40 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 0 | 0 | 0 |
| White | 26 | 10 | 36 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2020 to primary completion in Jun 2023, 33 months.
Results were first posted in Oct 2023, 3 months after primary completion.
Of 116 interventional studies with no phase under Skin Neoplasms, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 66. This study's 33 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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