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Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure
NA trial testing SHADE Ultraviolet Sensor in Skin Cancer in 111 participants. Completed in 31 March 2019.
| Lead sponsor | Weill Medical College of Cornell University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 111 |
| Start date | 11 October 2017 |
| Primary completion | 31 January 2019 |
| Estimated completion | 31 March 2019 |
| Sites | 1 location across United States |
Weill Medical College of Cornell University
Adults 18 to 80, any sex, with Skin Cancer or Actinic Keratoses. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Clinical counting of new actinic keratosis at 3 month intervals for a total duration of 6 months. Patient's actinic keratosis were counted at baseline (0 months), 3 months and 6 months. The average number of actinic keratosis at 6 months is only reported.
| Group | Value | 95% CI |
|---|---|---|
| Device: SHADE Ultraviolet Sensor | 4.53 | 0 – 14 |
| Standard of Care Counseling | 4.74 | 0 – 22 |
Clinical counting of new non melanoma skin cancers at 3 month intervals for a total duration of 6 months. Patient's non melanoma skin cancers were counted at baseline (0 months), 3 months and 6 months. The average number of non melanoma skin cancers at 6 months is only reported.
| Group | Value | 95% CI |
|---|---|---|
| Device: SHADE Ultraviolet Sensor | 0.04 | 0 – 1 |
| Standard of Care Counseling | 0.232 | 0 – 2 |
PROMIS (Patient-Reported Outcomes Measurement Information System) surveys will be given to patients at at baseline (0 months), 3 months and 6 month . Specifically we will include questions about anxiety, depression, and ability to participate in social roles and activities. The surveys will be scored on a scale of 1 to 5. 1 indicates never, 5 indicates always. An example of a question would be "I felt fearful" and the patient would score this question on a scale of 1-5 as indicated above. The results are scored using item-level calibrations via HealthMeasures.net Scoring Service. The total raw
| Group | Value | 95% CI |
|---|---|---|
| Device: SHADE Ultraviolet Sensor | 44.2 | 38 – 62 |
| Standard of Care Counseling | 43.6 | 38 – 55 |
| Group | Value | 95% CI |
|---|---|---|
| Device: SHADE Ultraviolet Sensor | 45.3 | 38 – 62 |
| Standard of Care Counseling | 43.7 | 38 – 59 |
PROMIS (Patient-Reported Outcomes Measurement Information System) surveys will be given to patients at at baseline (0 months), 3 months and 6 month . Specifically we will include questions about anxiety, depression, and ability to participate in social roles and activities. The surveys will be scored on a scale of 1 to 5. 1 indicates never, 5 indicates always. An example of a question would be "I felt fearful" and the patient would score this question on a scale of 1-5 as indicated above. The results are scored using item-level calibrations via HealthMeasures.net Scoring Service. The total raw
| Group | Value | 95% CI |
|---|---|---|
| Device: SHADE Ultraviolet Sensor | 46.2 | 37 – 63 |
| Standard of Care Counseling | 44.1 | 37 – 65 |
| Group | Value | 95% CI |
|---|---|---|
| Device: SHADE Ultraviolet Sensor | 46.3 | 37 – 66 |
| Standard of Care Counseling | 44.7 | 37 – 63 |
PROMIS (Patient-Reported Outcomes Measurement Information System) surveys will be given to patients at at baseline (0 months), 3 months and 6 month . Specifically we will include questions about anxiety, depression, and ability to participate in social roles and activities. The surveys will be scored on a scale of 1 to 5. 1 indicates never, 5 indicates always. An example of a question would be "I felt fearful" and the patient would score this question on a scale of 1-5 as indicated above. The results are scored using item-level calibrations via HealthMeasures.net Scoring Service. The total raw
| Group | Value | 95% CI |
|---|---|---|
| Device: SHADE Ultraviolet Sensor | 57 | 34 – 65 |
| Standard of Care Counseling | 60 | 44 – 65 |
| Group | Value | 95% CI |
|---|---|---|
| Device: SHADE Ultraviolet Sensor | 55.8 | 36 – 65 |
| Standard of Care Counseling | 62.1 | 47 – 65 |
Clinical counting of new non melanoma skin cancers at 3 month intervals for a total duration of 6 months. Patient's melanoma skin cancers were counted at baseline (0 months), 3 months and 6 months. The number of melanoma skin cancers at each time point is reported.
| Group | Value | 95% CI |
|---|---|---|
| Device: SHADE Ultraviolet Sensor | 0 | |
| Standard of Care Counseling | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Device: SHADE Ultraviolet Sensor | 0 | |
| Standard of Care Counseling | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Device: SHADE Ultraviolet Sensor | 0 | |
| Standard of Care Counseling | 1 |
This study will evaluate the safety and effectiveness of Shade for the management of UV-induced skin complications and data collected from this study will be used to support the proposed indications for use.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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