Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions

NCT07556380 | Not Yet Recruiting

• 2 other identifiers: IRB_001745381R34CA283480-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate 5 different smartphone administered sun protection interventions that aim to reduce unprotected sun exposure in melanoma survivors. Participants are asked to wear an ultraviolet (UV) device and an activity monitor (Actigraph) to measure their daily UV exposure and track their physical activity for three separate assessment weeks and complete daily surveys. After the first assessment week, eligible participants are assigned up to 5 different sun protection interventions that are administered through a smartphone application for 8 weeks. Following 8-week use of the sun protection interventions, participants complete another assessment week. At the end of the assessment week, participants provide feedback on the design and usability of the UV device, smartphone application and each of the sun protection interventions that they experienced. One year later, participants are contacted again to complete a final assessment week.

Conditions

Melanoma (Skin Cancer)

Keywords

Wearable; Smartphone; Device; Melanoma; Physical activity; Cancer; Actigraph; Sun protection; Sunscreen; Goals; Health; Ultraviolet radiation

Outcome Measures

Primary Outcomes (5)

• Feasibility: Retention Rates

  Retention rates will be calculated for the overall study and separately for each component. Feasibility target: \<=30% treatment drop-out (or lost to follow-up) in at-least one treatment component. Investigators will report feasibility in aggregate and by site.

  Intervention period (weeks 2-9)

• Feasibility: Completion of Daily Assessment Week Surveys

  Assessment completion will be calculated for daily surveys (a combination of MUSE and device logging) completed during each assessment week. Feasibility target: \>=80% completion. Investigators will report feasibility in aggregate and by site.

  1-week bursts at baseline, post-intervention (2 months later) and 12 months post baseline.

• Feasibility: Completion of Pre-Assessment Week Surveys

  Assessment completion will be calculated for the Pre-Assessment Week Survey (a combination of the Sun Habits Survey, Social Cognitive Theory Questions and Godin Leisure-Time Questionnaire) completed once at the start of each assessment week. Feasibility target: \>=80% completion. Investigators will report feasibility in aggregate and by site.

  1-week bursts at baseline, post-intervention (2 months later) and 12 months post baseline.

• Feasibility: Weekly Device Wear

  Device wear will be calculated for the UVR sensor and Actigraph (number of days worn more than 8 hours at each assessment week). Feasibility target: \>=80% completion. Investigators will report feasibility in aggregate and by site.

  1-week bursts at baseline, post-intervention (2 months later) and 12 months post baseline.

• Unprotected Sun Exposure

  Unprotected Sun Exposure is calculated based on a combination of self-report and sensor data. The Daily MUSE Inventory, will be used to assess sun exposure based on the outdoor activities that a participant completes. On this measure, participants first select the type, timing, and clothing worn by activity performed. Participants then report on applications of sunscreen, including time applied (or reapplied), body sites covered, and SPF. The UVR sensor will continually assess UVR dose during assessment weeks. The information from the Daily MUSE Inventory will be aligned with data from UVR sensors to generate, unprotected sun exposure, which is the UVR dose weighted by the proportion of body surface area exposed.

  1-week bursts at baseline, post-intervention (2 months later), and 12 months post baseline.

Secondary Outcomes (3)

• Feasibility: Response Rates to Intervention Components

  Intervention period (weeks 2-9)

• Sunburns

  1-week bursts at baseline, post-intervention (2 months later), and 12 months post baseline.

• Usability, Burden, and Acceptability Self-Reports

  Post-assessment week 2 (2.5 months later)

Study Arms (32)

Experimental Condition 1

EXPERIMENTAL

Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Health Coaching + Action Planning

Behavioral: UV Real-Time Alerts; Behavioral: Track Your Sun Protection; Behavioral: Current Conditions; Behavioral: Health Coaching; Behavioral: Action Planning; Behavioral: Core Components

Experimental Condition 2

EXPERIMENTAL

Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Health Coaching

Behavioral: UV Real-Time Alerts; Behavioral: Track Your Sun Protection; Behavioral: Current Conditions; Behavioral: Health Coaching; Behavioral: Core Components

Experimental Condition 3

EXPERIMENTAL

Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Action Planning

Behavioral: UV Real-Time Alerts; Behavioral: Track Your Sun Protection; Behavioral: Current Conditions; Behavioral: Action Planning; Behavioral: Core Components

Experimental Condition 4

EXPERIMENTAL

Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions

Behavioral: UV Real-Time Alerts; Behavioral: Track Your Sun Protection; Behavioral: Current Conditions; Behavioral: Core Components

Experimental Condition 5

EXPERIMENTAL

Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Health Coaching + Action Planning

Behavioral: UV Real-Time Alerts; Behavioral: Track Your Sun Protection; Behavioral: Health Coaching; Behavioral: Action Planning; Behavioral: Core Components

Experimental Condition 6

EXPERIMENTAL

Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Health Coaching

Behavioral: UV Real-Time Alerts; Behavioral: Track Your Sun Protection; Behavioral: Health Coaching; Behavioral: Core Components

Experimental Condition 7

EXPERIMENTAL

Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Action Planning

Behavioral: UV Real-Time Alerts; Behavioral: Track Your Sun Protection; Behavioral: Action Planning; Behavioral: Core Components

Experimental Condition 8

EXPERIMENTAL

Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection

Behavioral: UV Real-Time Alerts; Behavioral: Track Your Sun Protection; Behavioral: Core Components

Experimental Condition 9

EXPERIMENTAL

Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Health Coaching + Action Planning

Behavioral: UV Real-Time Alerts; Behavioral: Current Conditions; Behavioral: Health Coaching; Behavioral: Action Planning; Behavioral: Core Components

Experimental Condition 10

EXPERIMENTAL

Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Health Coaching

Behavioral: UV Real-Time Alerts; Behavioral: Current Conditions; Behavioral: Health Coaching; Behavioral: Core Components

Experimental Condition 11

EXPERIMENTAL

Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Action Planning

Behavioral: UV Real-Time Alerts; Behavioral: Current Conditions; Behavioral: Action Planning; Behavioral: Core Components

Experimental Condition 12

EXPERIMENTAL

Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions

Behavioral: UV Real-Time Alerts; Behavioral: Current Conditions; Behavioral: Core Components

Experimental Condition 13

EXPERIMENTAL

Research participant receives the Core Components + UV Real-Time Alerts + Health Coaching + Action Planning

Behavioral: UV Real-Time Alerts; Behavioral: Health Coaching; Behavioral: Action Planning; Behavioral: Core Components

Experimental Condition 14

EXPERIMENTAL

Research participant receives the Core Components + UV Real-Time Alerts + Health Coaching

Behavioral: UV Real-Time Alerts; Behavioral: Health Coaching; Behavioral: Core Components

Experimental Condition 15

EXPERIMENTAL

Research participant receives the Core Components + UV Real-Time Alerts + Action Planning

Behavioral: UV Real-Time Alerts; Behavioral: Action Planning; Behavioral: Core Components

Experimental Condition 16

EXPERIMENTAL

Research participant receives the Core Components + UV Real-Time Alerts

Behavioral: UV Real-Time Alerts; Behavioral: Core Components

Experimental Condition 17

EXPERIMENTAL

Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Health Coaching + Action Planning

Behavioral: Track Your Sun Protection; Behavioral: Current Conditions; Behavioral: Health Coaching; Behavioral: Action Planning; Behavioral: Core Components

Experimental Condition 18

EXPERIMENTAL

Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Health Coaching

Behavioral: Track Your Sun Protection; Behavioral: Current Conditions; Behavioral: Health Coaching; Behavioral: Core Components

Experimental Condition 19

EXPERIMENTAL

Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Action Planning

Behavioral: Track Your Sun Protection; Behavioral: Current Conditions; Behavioral: Action Planning; Behavioral: Core Components

Experimental Condition 20

EXPERIMENTAL

Research participant receives the Core Components + Track Your Sun Protection + Current Conditions

Behavioral: Track Your Sun Protection; Behavioral: Current Conditions; Behavioral: Core Components

Experimental Condition 21

EXPERIMENTAL

Research participant receives the Core Components + Track Your Sun Protection + Health Coaching + Action Planning

Behavioral: Track Your Sun Protection; Behavioral: Health Coaching; Behavioral: Action Planning; Behavioral: Core Components

Experimental Condition 22

EXPERIMENTAL

Research participant receives the Core Components + Track Your Sun Protection + Health Coaching

Behavioral: Track Your Sun Protection; Behavioral: Health Coaching; Behavioral: Core Components

Experimental Condition 23

EXPERIMENTAL

Research participant receives the Core Components + Track Your Sun Protection + Action Planning

Behavioral: Track Your Sun Protection; Behavioral: Action Planning; Behavioral: Core Components

Experimental Condition 24

EXPERIMENTAL

Research participant receives the Core Components + Track Your Sun Protection

Behavioral: Track Your Sun Protection; Behavioral: Core Components

Experimental Condition 25

EXPERIMENTAL

Research participant receives the Core Components + Current Conditions + Health Coaching + Action Planning

Behavioral: Current Conditions; Behavioral: Health Coaching; Behavioral: Action Planning; Behavioral: Core Components

Experimental Condition 26

EXPERIMENTAL

Research participant receives the Core Components + Current Conditions + Health Coaching

Behavioral: Current Conditions; Behavioral: Health Coaching; Behavioral: Core Components

Experimental Condition 27

EXPERIMENTAL

Research participant receives the Core Components + Current Conditions + Action Planning

Behavioral: Current Conditions; Behavioral: Action Planning; Behavioral: Core Components

Experimental Condition 28

EXPERIMENTAL

Research participant receives the Core Components + Current Conditions

Behavioral: Current Conditions; Behavioral: Core Components

Experimental Condition 29

EXPERIMENTAL

Research participant receives the Core Components + Health Coaching + Action Planning

Behavioral: Health Coaching; Behavioral: Action Planning; Behavioral: Core Components

Experimental Condition 30

EXPERIMENTAL

Research participant receives the Core Components + Health Coaching

Behavioral: Health Coaching; Behavioral: Core Components

Experimental Condition 31

EXPERIMENTAL

Research participant receives the Core Components + Action Planning

Behavioral: Action Planning; Behavioral: Core Components

Experimental Condition 32

EXPERIMENTAL

Research participant receives the Core Components only

Behavioral: Core Components

Interventions

UV Real-Time Alerts BEHAVIORAL

Participants will receive text-based alerts about high-risk sun exposure as assessed by their UV device. If they are assigned this intervention, they will use a UV device.

Experimental Condition 1; Experimental Condition 10; Experimental Condition 11; Experimental Condition 12; Experimental Condition 13; Experimental Condition 14; Experimental Condition 15; Experimental Condition 16; Experimental Condition 2; Experimental Condition 3; Experimental Condition 4; Experimental Condition 5; Experimental Condition 6; Experimental Condition 7; Experimental Condition 8; Experimental Condition 9

Track Your Sun Protection BEHAVIORAL

Participants report their clothing and sunscreen use on a digital avatar each time they go outdoors. If they are assigned this intervention, they will use a UV device.

Experimental Condition 1; Experimental Condition 17; Experimental Condition 18; Experimental Condition 19; Experimental Condition 2; Experimental Condition 20; Experimental Condition 21; Experimental Condition 22; Experimental Condition 23; Experimental Condition 24; Experimental Condition 3; Experimental Condition 4; Experimental Condition 5; Experimental Condition 6; Experimental Condition 7; Experimental Condition 8

Current Conditions BEHAVIORAL

This displays a participant's location's UVR index and notifies them of ultraviolet radiation forecasts for different times throughout the day.

Experimental Condition 1; Experimental Condition 10; Experimental Condition 11; Experimental Condition 12; Experimental Condition 17; Experimental Condition 18; Experimental Condition 19; Experimental Condition 2; Experimental Condition 20; Experimental Condition 25; Experimental Condition 26; Experimental Condition 27; Experimental Condition 28; Experimental Condition 3; Experimental Condition 4; Experimental Condition 9

Health Coaching BEHAVIORAL

Bi-weekly (four times total) a trained health coach will individually call participants to discuss progress towards sun protection goals and provide support and advice. Scheduled calls, pre-interview questions, and goals will be displayed in the app.

Experimental Condition 1; Experimental Condition 10; Experimental Condition 13; Experimental Condition 14; Experimental Condition 17; Experimental Condition 18; Experimental Condition 2; Experimental Condition 21; Experimental Condition 22; Experimental Condition 25; Experimental Condition 26; Experimental Condition 29; Experimental Condition 30; Experimental Condition 5; Experimental Condition 6; Experimental Condition 9

Action Planning BEHAVIORAL

Participants will be instructed on how to set action plans for sun protection and will receive information from a mobile app about setting plans for enacting health behaviors and counteracting barriers.

Experimental Condition 1; Experimental Condition 11; Experimental Condition 13; Experimental Condition 15; Experimental Condition 17; Experimental Condition 19; Experimental Condition 21; Experimental Condition 23; Experimental Condition 25; Experimental Condition 27; Experimental Condition 29; Experimental Condition 3; Experimental Condition 31; Experimental Condition 5; Experimental Condition 7; Experimental Condition 9

Core Components BEHAVIORAL

All participants receive two core components, messages and lessons. Messages delivers two helpful UV protection tips per week and lessons contains 5 UV education courses for participants to read.

Experimental Condition 1; Experimental Condition 10; Experimental Condition 11; Experimental Condition 12; Experimental Condition 13; Experimental Condition 14; Experimental Condition 15; Experimental Condition 16; Experimental Condition 17; Experimental Condition 18; Experimental Condition 19; Experimental Condition 2; Experimental Condition 20; Experimental Condition 21; Experimental Condition 22; Experimental Condition 23; Experimental Condition 24; Experimental Condition 25; Experimental Condition 26; Experimental Condition 27; Experimental Condition 28; Experimental Condition 29; Experimental Condition 3; Experimental Condition 30; Experimental Condition 31; Experimental Condition 32; Experimental Condition 4; Experimental Condition 5; Experimental Condition 6; Experimental Condition 7; Experimental Condition 8; Experimental Condition 9

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is able to speak, read and write in English
• Had previous melanoma diagnosis with no melanoma treatment in the last three months
• Has no current Melanomas or untreated skin cancer
• Reports spending at least 15 minutes outside per day during Spring/ Summer on both weekdays and weekends
• Owns a smartphone with access to both Bluetooth and WIFI
• Is willing to use the UV device and Actigraph during waking hours
• Is willing to download and use a study app
• Is willing to actively participate in the study for up to 1 year

You may not qualify if:

• Has a medical condition preventing moderate-to-vigorous physical activity (MVPA) or a doctor recommendation to avoid MVPA
• Is currently enrolled in another study on MVPA

Sponsors & Collaborators

• Northwestern University: lead
• National Institutes of Health (NIH): collaborator
• Huntsman Cancer Institute/ University of Utah: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Huntsman Cancer Institute at The University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Melanoma; Motor Activity; Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Nabil Alshurafa, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Tammy Stump, PhD

  Huntsman Cancer Institute at The University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nabil Alshurafa, PhD

CONTACT

312-503-4517; nabil@northwestern.edu

Bonnie Nolan

CONTACT

312-503-1216; bonnie.nolan@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Full-factorial 2 (ON/OFF) \^ 5 (Intervention Component) design. Participants are randomly assigned to 1 of 32 experimental conditions, thereby experiencing up to 5 sun protection interventions.

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 29, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)