Background: Individuals who have been diagnosed with melanoma have more than a 9-fold increased risk of developing another melanoma. Ultraviolet radiation (UVR) exposure following a melanoma diagnosis can be modified to reduce risk of a new melanoma diagnosis. Yet research shows that many melanoma survivors do not report optimal sun protection practices. The objective of this study is to evaluate the effectiveness of a UVR-sensor wearable device to improve sun protection behaviors and reduce sunburns in a randomized controlled trial (RCT) in melanoma survivors. Methods: We will conduct an RCT among 368 melanoma survivors in two waves (Summer 2020, Summer 2021). This approach allows for adequate recruitment of the required sample and potential improvements to recruitment, compliance, and retention strategies between waves. The intervention includes an informational brochure about sun protection behaviors and a commercially available UVR-sensor wearable device (Shade), which accurately measures UVR. The device, along with its associated mobile application, measures and stores UVR exposure. As UVR exposure accumulates, the device provides notifications to increase sun protection action. Survivors in the control group receive the device and a separate mobile application that does not provide notifications or summary UVR exposure data. Participants will be asked to wear the device for 12 weeks. They will complete surveys about their sun behaviors at study entry, every 4 weeks during the intervention, and 1 year later. At the end of the intervention period, intervention and control groups will be compared for differences in a summary measure of sun protection habits and experience of a sunburn. We will also measure self-reported physical activity, depression, and anxiety to examine potential unintended negative consequences of the intervention. Discussion: The study intervention will be completed Fall 2021, with anticipated results available in 2022. If this intervention improves sun protection behaviors in melanoma survivors, these findings would support expanding the use of this technology with other populations at high risk for melanoma. Trial registration: ClinicalTrials.gov NCT03927742. Registered on April 15, 2019.
Bibliographical noteFunding Information:
This study is funded by the Melanoma Research Alliance: The Wayne Stinchcomb Big Orange Foundation – MRA Young Investigator Award (568166) and the American Cancer Society Research Scholar Award (133512-RSG-19-014-01-CPPB). Preliminary studies for this protocol were supported the Masonic Cancer Center of the University of Minnesota grant NIH P30 CA77598. Use of data collection and management tools is supported by the National Institutes of Health’s National Center for Advancing Translational Sciences, grant UL1TR002494.
RIV is the Principal Investigator; she conceived the study, led the proposal and protocol development, and secured funding. RHN, RA, BCM, and DL contributed to the study design and development of the protocol. KB was involved in the development of the protocol and study implementation. XL contributed to study design and is the lead statistician. All authors read and approved the final manuscript. All authors on this protocol will be offered authorship on all trial publications, with order determined by group consensus with the PI having the final decision. No professional writers will be used. This study is funded by the Melanoma Research Alliance: The Wayne Stinchcomb Big Orange Foundation ? MRA Young Investigator Award (568166) and the American Cancer Society Research Scholar Award (133512-RSG-19-014-01-CPPB). Preliminary studies for this protocol were supported the Masonic Cancer Center of the University of Minnesota grant NIH P30 CA77598. Use of data collection and management tools is supported by the National Institutes of Health?s National Center for Advancing Translational Sciences, grant UL1TR002494. The principal investigator and study coordinator will have access to the full dataset. The statistician and other study team members will have access to the de-identified trial dataset. The individual-level data will not be shared outside of the study group. University of Minnesota Institutional Review Board, FWA number 00000312 and HealthPartners Institute Institutional Review Board, FWA 00000106. Written/electronic, informed consent to participate will be obtained from all participants. The informed consent document has been included as a supplemental file. The authors declare that they have no competing interests.
- Cancer survivors
- Ecological momentary intervention
- Sun protection
- Ultraviolet exposure