Trial Outcomes & Findings for Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors (NCT NCT03927742)

Last Updated: 2024-05-13

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

368 participants

Primary outcome timeframe

12 weeks (post intervention)

Results posted on

2024-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	Shade and Application With UV Message Activated wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging activated Shade + app with messaging: Shade wearable device and application with UV messaging activated	Shade and Application Without UV Messaging wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging not activated Shape + app without messaging: Shade wearable device and application without UV messaging activated
Overall Study STARTED	182	186
Overall Study COMPLETED	166	174
Overall Study NOT COMPLETED	16	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Shade and Application With UV Message Activated n=182 Participants wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging activated Shade + app with messaging: Shade wearable device and application with UV messaging activated	Shade and Application Without UV Messaging n=186 Participants wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging not activated Shape + app without messaging: Shade wearable device and application without UV messaging activated	Total n=368 Participants Total of all reporting groups
Age, Continuous	56.5 years STANDARD_DEVIATION 11.9 • n=99 Participants	55.3 years STANDARD_DEVIATION 11.5 • n=107 Participants	56 years STANDARD_DEVIATION 11.7 • n=206 Participants
Sex: Female, Male Female	111 Participants n=99 Participants	110 Participants n=107 Participants	221 Participants n=206 Participants
Sex: Female, Male Male	71 Participants n=99 Participants	76 Participants n=107 Participants	147 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	174 Participants n=99 Participants	171 Participants n=107 Participants	345 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=99 Participants	15 Participants n=107 Participants	21 Participants n=206 Participants

PRIMARY outcome

Timeframe: 12 weeks (post intervention)

Outcome measures

Outcome measures
Measure	Shade and Application With UV Message Activated n=166 Participants wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging activated Shade + app with messaging: Shade wearable device and application with UV messaging activated	Shade and Application Without UV Messaging n=174 Participants wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging not activated Shape + app without messaging: Shade wearable device and application without UV messaging activated
Sun Protection Habits Index	2.9 scores on a scale Standard Deviation 0.5	3 scores on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 12 weeks (post intervention)

Glanz et al. (2007) validated question: In the past 12 months, how many times did you have a red OR painful sunburn that lasted a day or more? Self-reported options include 0, 1, 2, 3, 4, 5 or more.

Outcome measures

Outcome measures
Measure	Shade and Application With UV Message Activated n=166 Participants wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging activated Shade + app with messaging: Shade wearable device and application with UV messaging activated	Shade and Application Without UV Messaging n=174 Participants wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging not activated Shape + app without messaging: Shade wearable device and application without UV messaging activated
Number of Participants With Sunburn in the Past 12 Weeks	55 Participants	54 Participants

Adverse Events

Shade and Application With UV Message Activated

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Shade and Application Without UV Messaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rachel Vogel

University of Minnesota

Phone: 612-624-6928

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place