Pilot Study of Intervention to Reduce Sunburns in Melanoma Survivors

NCT03518229 | Withdrawn

• 1 other identifier: STUDY00002107
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This project will pilot test whether a wearable device that tracks sun exposure and provides alerts regarding sun exposure and protection behaviors will reduce sunburns in melanoma survivors. The use of wearable technology devices has grown quickly over the last decade and studies using these devices to promote physical activity and weight loss have been promising. The investigators will pilot test the technology device versus a similar control device in 80 melanoma survivors and compare sunburns between the two groups after the three month intervention.

Conditions

Melanoma (Skin)

Keywords

cancer prevention; sunburn

Outcome Measures

Primary Outcomes (1)

• Sunburn

  Self-report of a sunburn during study period

  3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Microsoft Band 2 application with UV messaging activated

Device: Microsoft Band 2 + UV messaging

Control

ACTIVE COMPARATOR

Microsoft Band 2 application (UV messaging not active)

Device: Microsoft Band 2

Interventions

Microsoft Band 2 + UV messaging DEVICE

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

Intervention

Microsoft Band 2 DEVICE

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

Control

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 stage I-III cutaneous invasive melanoma between 2009 and 2017 and treated at the University of Minnesota
• Able to read/write in English
• Own a smartphone
• Able to provide voluntary informed consent

You may not qualify if:

• Patients currently undergoing adjuvant therapy.

Sponsors & Collaborators

• University of Minnesota: lead
• Melanoma Research Alliance: collaborator

MeSH Terms

Conditions

Melanoma; Sunburn

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

Study Design

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

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: May 8, 2018
• Study Start: February 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: May 1, 2021
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share