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| ID | Type | Description | Link |
|---|---|---|---|
| 133512-RSG-19-014-01-CPPB | Other Grant/Funding Number | American Cancer Society |
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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
| Melanoma Research Alliance | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shade and application with UV message activated | Experimental | wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging activated |
|
| Shade and application without UV messaging | Active Comparator | wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging not activated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shade + app with messaging | Behavioral | Shade wearable device and application with UV messaging activated |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks (post intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36763627 | Derived | 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. | |
| 33228807 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Shade and Application Without UV Messaging |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks (post intervention) |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Vogel | University of Minnesota | 612-624-6928 | isak0023@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 19, 2021 | Feb 24, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 1, 2020 | Feb 24, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D013471 | Sunburn |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000682 | Amyloid |
| ID | Term |
|---|---|
| D046912 | Multiprotein Complexes |
| D046911 | Macromolecular Substances |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Shape + app without messaging | Behavioral | Shade wearable device and application without UV messaging activated |
|
| 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. |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 |
|
|
| 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. | Posted | Count of Participants | Participants | 12 weeks (post intervention) |
|
|
|
| 0 |
| 166 |
| 0 |
| 166 |
| 0 |
| 166 |
| EG001 | 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 | 0 | 174 | 0 | 174 | 0 | 174 |
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010787 | Photosensitivity Disorders |
| D002056 | Burns |
| D014947 | Wounds and Injuries |