Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors

NCT03927742 | Completed Results

• 2 other identifiers: 2019NTLS079133512-RSG-19-014-01-CPPB
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 1

Brief Summary

Over 5 million new cases of skin cancer are diagnosed in the United States each year, more than all other cancers combined. Most of these cases are caused by excess exposure to ultraviolet radiation from the sun and artificial sources such as indoor tanning. Melanoma, approximately 87,000 of the annual skin cancer cases and one of the more deadly skin cancers, is on the rise. Previous research on these individuals suggests that while some change how much time they spend in the sun and adopt ways to protect themselves when in the sun, many do not. In our previous study, we found that 20% of melanoma survivors reported a sunburn in the past year and 10% intentionally went outside for a tan, both strong indicators of inappropriate sun exposure. Melanoma survivors are at high risk of second melanomas, making it critical that they spend less time in the sun or take actions to protect themselves when they are in the sun. No studies to date have investigated technology-based strategies in melanoma survivors to improve sun exposure and protection behaviors. This project will test whether a wearable device that tracks sun exposure and provides alerts regarding sun exposure and protection behaviors will increase sun protection behaviors in melanoma survivors. The use of wearable technology devices (e.g., Fitbit) has grown quickly over the last decade and studies using these devices to promote physical activity and weight loss have been promising. We will test the technology device versus a similar control device in 368 melanoma survivors and compare sun protection behaviors between the two groups. This project has the potential to identify a strategy that could significantly lower the number of melanoma survivors who go on to have a second melanoma diagnosis. Importantly, this easy to use technology could also be utilized by survivors' family members, who are also at higher risk for melanoma, and the general population as a means to reduce risk of all forms of skin cancer.

Conditions

Melanoma (Skin)

Keywords

sun protection; sunburn

Outcome Measures

Primary Outcomes (1)

• Sun Protection Habits Index

  Sun protection habits measured using Glanz et al., 2008 questionnaire and scored by taking the averaging of 6 protective behaviors (wearing a shirt with sleeves, wearing sunglasses, staying in the shade, using sunscreen, limiting time in the sun, and wearing a hat) on a 4-point ordinal scale ranging from 1 = rarely or never to 4 = always. (Glanz et al. 2010). Higher score indicates better sun protection behaviors

  12 weeks (post intervention)

Secondary Outcomes (1)

• Number of Participants With Sunburn in the Past 12 Weeks

  12 weeks (post intervention)

Study Arms (2)

Shade and application with UV message activated

EXPERIMENTAL

wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging activated

Behavioral: Shade + app with messaging

Shade and application without UV messaging

ACTIVE COMPARATOR

wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging not activated

Behavioral: Shape + app without messaging

Interventions

Shade + app with messaging BEHAVIORAL

Shade wearable device and application with UV messaging activated

Shade and application with UV message activated

Shape + app without messaging BEHAVIORAL

Shade wearable device and application without UV messaging activated

Shade and application without UV messaging

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Diagnosed with cutaneous invasive melanoma within HealthPartners system
• Able to read/write in English
• Own a smartphone
• Able to provide voluntary informed consent

You may not qualify if:

• Patients who have opted out of their records being used for research purposes
• Inability to provide informed written consent
• Pregnancy

Sponsors & Collaborators

• University of Minnesota: lead
• American Cancer Society, Inc.: collaborator
• Melanoma Research Alliance: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (2)

• Vogel RI, Luo X, Brown K, Jewett P, Dona AC, Nagler RH, Ahmed RL, Martinson BC, Lazovich D. A UVR-sensor wearable device intervention to reduce sun exposure in melanoma survivors: Results from a randomized controlled trial. PLoS One. 2023 Feb 10;18(2):e0281480. doi: 10.1371/journal.pone.0281480. eCollection 2023.

  PMID: 36763627 DERIVED

• Vogel RI, Nagler RH, Ahmed RL, Brown K, Luo X, Martinson BC, Lazovich D. UVR-sensor wearable device intervention to improve sun behaviors and reduce sunburns in melanoma survivors: study protocol of a parallel-group randomized controlled trial. Trials. 2020 Nov 23;21(1):959. doi: 10.1186/s13063-020-04881-3.

  PMID: 33228807 DERIVED

MeSH Terms

Conditions

Melanoma; Sunburn

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Photosensitivity Disorders; Burns; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Rachel Vogel
• Organization: University of Minnesota

isak0023@umn.edu

612-624-6928

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 25, 2019
• Study Start: June 9, 2020
• Primary Completion: November 1, 2021
• Study Completion: October 31, 2022
• Last Updated: May 13, 2024
• Results First Posted: May 13, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)