Melanoma (Skin)
Conditions
Keywords
sun protection, sunburn
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.
Interventions
BEHAVIORALShade + app with messaging
Shade wearable device and application with UV messaging activated
BEHAVIORALShape + app without messaging
Shade wearable device and application without UV messaging activated
Sponsors
American Cancer Society, Inc.
Melanoma Research Alliance
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18-75 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
Exclusion criteria
* Patients who have opted out of their records being used for research purposes * Inability to provide informed written consent * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sun Protection Habits Index | 12 weeks (post intervention) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Sunburn in the Past 12 Weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 182 |
| 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 | 186 |
| Total | 368 |
Baseline characteristics
| Characteristic | Shade and Application With UV Message Activated | Total | Shade and Application Without UV Messaging |
|---|---|---|---|
| Age, Continuous | 56.5 years STANDARD_DEVIATION 11.9 | 56 years STANDARD_DEVIATION 11.7 | 55.3 years STANDARD_DEVIATION 11.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 21 Participants | 15 Participants |
| Race (NIH/OMB) White | 174 Participants | 345 Participants | 171 Participants |
| Sex: Female, Male Female | 111 Participants | 221 Participants | 110 Participants |
| Sex: Female, Male Male | 71 Participants | 147 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 166 | 0 / 174 |
| other Total, other adverse events | 0 / 166 | 0 / 174 |
| serious Total, serious adverse events | 0 / 166 | 0 / 174 |
Outcome results
Primary
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
Time frame: 12 weeks (post intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Shade and Application With UV Message Activated | Sun Protection Habits Index | 2.9 scores on a scale | Standard Deviation 0.5 |
| Shade and Application Without UV Messaging | Sun Protection Habits Index | 3 scores on a scale | Standard Deviation 0.5 |
Secondary
Number of Participants With Sunburn in the Past 12 Weeks
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.
Time frame: 12 weeks (post intervention)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Shade and Application With UV Message Activated | Number of Participants With Sunburn in the Past 12 Weeks | 55 Participants |
| Shade and Application Without UV Messaging | Number of Participants With Sunburn in the Past 12 Weeks | 54 Participants |