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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34CA283480-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Huntsman Cancer Institute/ University of Utah | UNKNOWN |
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to evaluate 5 different smartphone administered sun protection interventions that aim to reduce unprotected sun exposure in melanoma survivors. Participants are asked to wear an ultraviolet (UV) device and an activity monitor (Actigraph) to measure their daily UV exposure and track their physical activity for three separate assessment weeks and complete daily surveys. After the first assessment week, eligible participants are assigned up to 5 different sun protection interventions that are administered through a smartphone application for 8 weeks. Following 8-week use of the sun protection interventions, participants complete another assessment week. At the end of the assessment week, participants provide feedback on the design and usability of the UV device, smartphone application and each of the sun protection interventions that they experienced. One year later, participants are contacted again to complete a final assessment week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Condition 1 | Experimental | Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Health Coaching + Action Planning |
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| Experimental Condition 2 | Experimental | Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Health Coaching |
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| Experimental Condition 3 | Experimental | Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Action Planning |
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| Experimental Condition 4 | Experimental | Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UV Real-Time Alerts | Behavioral | Participants will receive text-based alerts about high-risk sun exposure as assessed by their UV device. If they are assigned this intervention, they will use a UV device. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Retention Rates | Retention rates will be calculated for the overall study and separately for each component. Feasibility target: <=30% treatment drop-out (or lost to follow-up) in at-least one treatment component. Investigators will report feasibility in aggregate and by site. | Intervention period (weeks 2-9) |
| Feasibility: Completion of Daily Assessment Week Surveys | Assessment completion will be calculated for daily surveys (a combination of MUSE and device logging) completed during each assessment week. Feasibility target: >=80% completion. Investigators will report feasibility in aggregate and by site. | 1-week bursts at baseline, post-intervention (2 months later) and 12 months post baseline. |
| Feasibility: Completion of Pre-Assessment Week Surveys | Assessment completion will be calculated for the Pre-Assessment Week Survey (a combination of the Sun Habits Survey, Social Cognitive Theory Questions and Godin Leisure-Time Questionnaire) completed once at the start of each assessment week. Feasibility target: >=80% completion. Investigators will report feasibility in aggregate and by site. | 1-week bursts at baseline, post-intervention (2 months later) and 12 months post baseline. |
| Feasibility: Weekly Device Wear | Device wear will be calculated for the UVR sensor and Actigraph (number of days worn more than 8 hours at each assessment week). Feasibility target: >=80% completion. Investigators will report feasibility in aggregate and by site. | 1-week bursts at baseline, post-intervention (2 months later) and 12 months post baseline. |
| Unprotected Sun Exposure | Unprotected Sun Exposure is calculated based on a combination of self-report and sensor data. The Daily MUSE Inventory, will be used to assess sun exposure based on the outdoor activities that a participant completes. On this measure, participants first select the type, timing, and clothing worn by activity performed. Participants then report on applications of sunscreen, including time applied (or reapplied), body sites covered, and SPF. The UVR sensor will continually assess UVR dose during assessment weeks. The information from the Daily MUSE Inventory will be aligned with data from UVR sensors to generate, unprotected sun exposure, which is the UVR dose weighted by the proportion of body surface area exposed. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Response Rates to Intervention Components | Response (engagement) rates will be calculated separately for each intervention type, with denominator varying by intervention, based on number of engagement opportunities. | Intervention period (weeks 2-9) |
| Sunburns |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nabil Alshurafa, PhD | Contact | 312-503-4517 | nabil@northwestern.edu | |
| Bonnie Nolan | Contact | 312-503-1216 | bonnie.nolan@northwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nabil Alshurafa, PhD | Northwestern University | Principal Investigator |
| Tammy Stump, PhD | Huntsman Cancer Institute at The University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D009043 | Motor Activity |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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Full-factorial 2 (ON/OFF) ^ 5 (Intervention Component) design. Participants are randomly assigned to 1 of 32 experimental conditions, thereby experiencing up to 5 sun protection interventions.
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| Experimental Condition 5 | Experimental | Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Health Coaching + Action Planning |
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| Experimental Condition 6 | Experimental | Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Health Coaching |
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| Experimental Condition 7 | Experimental | Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Action Planning |
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| Experimental Condition 8 | Experimental | Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection |
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| Experimental Condition 9 | Experimental | Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Health Coaching + Action Planning |
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| Experimental Condition 10 | Experimental | Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Health Coaching |
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| Experimental Condition 11 | Experimental | Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Action Planning |
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| Experimental Condition 12 | Experimental | Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions |
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| Experimental Condition 13 | Experimental | Research participant receives the Core Components + UV Real-Time Alerts + Health Coaching + Action Planning |
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| Experimental Condition 14 | Experimental | Research participant receives the Core Components + UV Real-Time Alerts + Health Coaching |
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| Experimental Condition 15 | Experimental | Research participant receives the Core Components + UV Real-Time Alerts + Action Planning |
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| Experimental Condition 16 | Experimental | Research participant receives the Core Components + UV Real-Time Alerts |
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| Experimental Condition 17 | Experimental | Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Health Coaching + Action Planning |
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| Experimental Condition 18 | Experimental | Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Health Coaching |
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| Experimental Condition 19 | Experimental | Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Action Planning |
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| Experimental Condition 20 | Experimental | Research participant receives the Core Components + Track Your Sun Protection + Current Conditions |
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| Experimental Condition 21 | Experimental | Research participant receives the Core Components + Track Your Sun Protection + Health Coaching + Action Planning |
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| Experimental Condition 22 | Experimental | Research participant receives the Core Components + Track Your Sun Protection + Health Coaching |
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| Experimental Condition 23 | Experimental | Research participant receives the Core Components + Track Your Sun Protection + Action Planning |
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| Experimental Condition 24 | Experimental | Research participant receives the Core Components + Track Your Sun Protection |
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| Experimental Condition 25 | Experimental | Research participant receives the Core Components + Current Conditions + Health Coaching + Action Planning |
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| Experimental Condition 26 | Experimental | Research participant receives the Core Components + Current Conditions + Health Coaching |
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| Experimental Condition 27 | Experimental | Research participant receives the Core Components + Current Conditions + Action Planning |
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| Experimental Condition 28 | Experimental | Research participant receives the Core Components + Current Conditions |
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| Experimental Condition 29 | Experimental | Research participant receives the Core Components + Health Coaching + Action Planning |
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| Experimental Condition 30 | Experimental | Research participant receives the Core Components + Health Coaching |
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| Experimental Condition 31 | Experimental | Research participant receives the Core Components + Action Planning |
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| Experimental Condition 32 | Experimental | Research participant receives the Core Components only |
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| Track Your Sun Protection | Behavioral | Participants report their clothing and sunscreen use on a digital avatar each time they go outdoors. If they are assigned this intervention, they will use a UV device. |
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| Current Conditions | Behavioral | This displays a participant's location's UVR index and notifies them of ultraviolet radiation forecasts for different times throughout the day. |
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| Health Coaching | Behavioral | Bi-weekly (four times total) a trained health coach will individually call participants to discuss progress towards sun protection goals and provide support and advice. Scheduled calls, pre-interview questions, and goals will be displayed in the app. |
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| Action Planning | Behavioral | Participants will be instructed on how to set action plans for sun protection and will receive information from a mobile app about setting plans for enacting health behaviors and counteracting barriers. |
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| Core Components | Behavioral | All participants receive two core components, messages and lessons. Messages delivers two helpful UV protection tips per week and lessons contains 5 UV education courses for participants to read. |
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| 1-week bursts at baseline, post-intervention (2 months later), and 12 months post baseline. |
Sunburns will be assessed using questions from the well-validated Sun Habits Survey including: "In the past month, how many times did you have a red or painful sunburn that lasted a day or more?" at the start of each of the three assessment windows. |
| 1-week bursts at baseline, post-intervention (2 months later), and 12 months post baseline. |
| Usability, Burden, and Acceptability Self-Reports | At the end of the study, participants will complete a User Burden Scale to assess difficulty of use, physical burden, time and social burden, mental and emotional burden, and privacy burden. The System Usability Scale will also be used to assess perceptions of the overall usability of the SESAME app and interventions. At the end of the intervention, participants will be asked to complete a one-on-one interview with the research team to assess acceptability of each of the five intervention components, comfort, and wearability concerns. | Post-assessment week 2 (2.5 months later) |
| Huntsman Cancer Institute at The University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
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| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001519 | Behavior |