NCT04977700

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 27, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
4 months until next milestone

Results Posted

Study results publicly available

October 18, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

2.8 years

First QC Date

July 2, 2021

Results QC Date

September 21, 2023

Last Update Submit

November 8, 2023

Conditions

Keywords

skin cancerphysical activity

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (6)

  • Physical Activity (Godin Leisure-Time Exercise Questionnaire)

    Baseline

  • Physical Activity (Godin Leisure-Time Exercise Questionnaire)

    four-weeks post intervention

  • Recall of Sun Protection Messages

    four weeks post intervention

  • Self-Efficacy for Sun Protection When Exercising

    baseline and four-weeks post intervention

  • Range of Physical Activity (Godin Leisure-Time Exercise Questionnaire)

    baseline

  • +1 more secondary outcomes

Study Arms (2)

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.

Behavioral: Intervention Group

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.

Interventions

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.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klein Buendel, Inc.

Golden, Colorado, 80401, United States

Location

MeSH Terms

Conditions

Skin NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Results Point of Contact

Title
Julia Berteletti
Organization
Klein Buendel, Inc.

Study Officials

  • Julia Berteletti, MSW

    Klein Buendel, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2021

First Posted

July 27, 2021

Study Start

September 1, 2020

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

November 13, 2023

Results First Posted

October 18, 2023

Record last verified: 2023-11

Locations