Randomized controlled trial of the mySmartSkin web-based intervention to promote skin self-examination and sun protection behaviors among individuals diagnosed with melanoma: study design and baseline characteristics

doi:10.1016/j.cct.2019.06.014

. 2019 Aug:83:117-127.

doi: 10.1016/j.cct.2019.06.014. Epub 2019 Jun 27.

Randomized controlled trial of the mySmartSkin web-based intervention to promote skin self-examination and sun protection behaviors among individuals diagnosed with melanoma: study design and baseline characteristics

Affiliations

¹ Rutgers Cancer Institute of New Jersey, Rutgers, The State University of New Jersey, New Brunswick, NJ, United States; Department of Medicine, Rutgers Robert Johnson Medical School, Rutgers, The State University of New Jersey, New Brunswick, NJ, United States; Department of Health Behavior, Systems & Policy, Rutgers School of Public Health, Rutgers, The State University of New Jersey, Piscataway, NJ, United States. Electronic address: elliot.coups@rutgers.edu.
² Rutgers Cancer Institute of New Jersey, Rutgers, The State University of New Jersey, New Brunswick, NJ, United States; Department of Medicine, Rutgers Robert Johnson Medical School, Rutgers, The State University of New Jersey, New Brunswick, NJ, United States; Department of Health Behavior, Systems & Policy, Rutgers School of Public Health, Rutgers, The State University of New Jersey, Piscataway, NJ, United States.
³ Department of Biostatistics and Epidemiology, Rutgers School of Public Health, Rutgers, The State University of New Jersey, New Brunswick, NJ, United States.
⁴ Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine, Charlottesville, VA, United States.
⁵ East Brunswick, NJ, United States.
⁶ Department of Dermatology, Rutgers Robert Wood Johnson Medical School, Rutgers, The State University of New Jersey, New Brunswick, NJ, United States.
⁷ Department of Surgery, Saint Barnabas Medical Center, Livingston, NJ, United States.
⁸ Pear Therapeutics, Boston, MA, United States.

PMID: 31255801
PMCID: PMC6690854
DOI: 10.1016/j.cct.2019.06.014

Randomized controlled trial of the mySmartSkin web-based intervention to promote skin self-examination and sun protection behaviors among individuals diagnosed with melanoma: study design and baseline characteristics

Elliot J Coups et al. Contemp Clin Trials. 2019 Aug.

. 2019 Aug:83:117-127.

doi: 10.1016/j.cct.2019.06.014. Epub 2019 Jun 27.

Authors

Affiliations

¹ Rutgers Cancer Institute of New Jersey, Rutgers, The State University of New Jersey, New Brunswick, NJ, United States; Department of Medicine, Rutgers Robert Johnson Medical School, Rutgers, The State University of New Jersey, New Brunswick, NJ, United States; Department of Health Behavior, Systems & Policy, Rutgers School of Public Health, Rutgers, The State University of New Jersey, Piscataway, NJ, United States. Electronic address: elliot.coups@rutgers.edu.
² Rutgers Cancer Institute of New Jersey, Rutgers, The State University of New Jersey, New Brunswick, NJ, United States; Department of Medicine, Rutgers Robert Johnson Medical School, Rutgers, The State University of New Jersey, New Brunswick, NJ, United States; Department of Health Behavior, Systems & Policy, Rutgers School of Public Health, Rutgers, The State University of New Jersey, Piscataway, NJ, United States.
³ Department of Biostatistics and Epidemiology, Rutgers School of Public Health, Rutgers, The State University of New Jersey, New Brunswick, NJ, United States.
⁴ Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine, Charlottesville, VA, United States.
⁵ East Brunswick, NJ, United States.
⁶ Department of Dermatology, Rutgers Robert Wood Johnson Medical School, Rutgers, The State University of New Jersey, New Brunswick, NJ, United States.
⁷ Department of Surgery, Saint Barnabas Medical Center, Livingston, NJ, United States.
⁸ Pear Therapeutics, Boston, MA, United States.

PMID: 31255801
PMCID: PMC6690854
DOI: 10.1016/j.cct.2019.06.014

Abstract

>1.2 million people in the United States have a personal history of melanoma skin cancer and are at increased risk for disease recurrence and second primary melanomas. Many of these individuals do not follow recommendations to conduct regular, thorough skin self-examinations that facilitate early disease detection and do not sufficiently engage in sun protection behaviors. In this project, we are conducting a randomized controlled trial of an innovative, tailored, theory-driven Internet intervention-called mySmartSkin-to promote these behaviors among melanoma patients. This paper outlines the study design and characteristics of the study sample. A total of 441 patients were recruited (40.9% response rate) and randomized to the mySmartSkin or a Usual Care condition. Participants complete surveys at baseline and 8 weeks, 24 weeks, and 48 weeks later. The primary aim of the project is to examine the impact of mySmartSkin versus Usual Care on skin self-examination and sun protection behaviors. The secondary aim focuses on identifying mediators of the intervention's effects. In an exploratory aim, we will examine potential moderators of the impact of the intervention. At baseline, the recruited participants had a mean age of 61 years, 49% were female, 7.5% met criteria for having conducted a recent, thorough skin self-examination, and the mean score on the index of sun protection behaviors was 3.3 (on a scale from 1 to 5). The results of the project will determine whether the mySmartSkin intervention is efficacious in promoting skin self-examination and sun protection behaviors among individuals diagnosed with melanoma. Trial registration: ClinicalTrials.govNCT03028948.

Keywords: Intervention; Melanoma; Prevention; Skin cancer; Skin self-examination; Sun protection.

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**Figure 1.**
CONSORT diagram of study enrollment and allocation.

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References

1. American Cancer Society. Cancer Facts & Figures 2019. Atlanta, GA: American Cancer Society; 2019.
1. Noone AM, Howlader N, Krapcho M, Miller D, Brest A, Yu M, Ruhl J, Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA (eds). SEER Cancer Statistics Review, 1975-2015, National Cancer Institute; Bethesda, MD,https://seer.cancer.gov/csr/1975_2015/, based on November 2017 SEER data submission, posted to the SEER web site, April 2018.
1. Linos E, Swetter SM, Cockburn MG, Colditz GA, Clarke CA. Increasing burden of melanoma in the united states. J Invest Dermatol 2009;129(7):1666–1674. PMID:19131946 - PMC - PubMed
1. Francken AB, Bastiaannet E, Hoekstra HJ. Follow-up in patients with localised primary cutaneous melanoma. Lancet Oncol 2005;6(8):608–621. PMID:16054572 - PubMed
1. Leiter U, Buettner PG, Eigentler TK, Brocker EB, Voit C, Gollnick H, Marsch W, Wollina U, Meier F, Garbe C. Hazard rates for recurrent and secondary cutaneous melanoma: An analysis of 33,384 patients in the german central malignant melanoma registry. J Am Acad Dermatol 2012;66:37–45. PMID:21700361 - PubMed

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[1] American Cancer Society. Cancer Facts & Figures 2019. Atlanta, GA: American Cancer Society; 2019.

[2] American Cancer Society. Cancer Facts & Figures 2019. Atlanta, GA: American Cancer Society; 2019.

[3] Noone AM, Howlader N, Krapcho M, Miller D, Brest A, Yu M, Ruhl J, Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA (eds). SEER Cancer Statistics Review, 1975-2015, National Cancer Institute; Bethesda, MD,https://seer.cancer.gov/csr/1975_2015/, based on November 2017 SEER data submission, posted to the SEER web site, April 2018.

[4] Noone AM, Howlader N, Krapcho M, Miller D, Brest A, Yu M, Ruhl J, Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA (eds). SEER Cancer Statistics Review, 1975-2015, National Cancer Institute; Bethesda, MD,https://seer.cancer.gov/csr/1975_2015/, based on November 2017 SEER data submission, posted to the SEER web site, April 2018.

[5] Linos E, Swetter SM, Cockburn MG, Colditz GA, Clarke CA. Increasing burden of melanoma in the united states. J Invest Dermatol 2009;129(7):1666–1674. PMID:19131946 - PMC - PubMed

[6] Linos E, Swetter SM, Cockburn MG, Colditz GA, Clarke CA. Increasing burden of melanoma in the united states. J Invest Dermatol 2009;129(7):1666–1674. PMID:19131946 - PMC - PubMed

[7] Francken AB, Bastiaannet E, Hoekstra HJ. Follow-up in patients with localised primary cutaneous melanoma. Lancet Oncol 2005;6(8):608–621. PMID:16054572 - PubMed

[8] Francken AB, Bastiaannet E, Hoekstra HJ. Follow-up in patients with localised primary cutaneous melanoma. Lancet Oncol 2005;6(8):608–621. PMID:16054572 - PubMed

[9] Leiter U, Buettner PG, Eigentler TK, Brocker EB, Voit C, Gollnick H, Marsch W, Wollina U, Meier F, Garbe C. Hazard rates for recurrent and secondary cutaneous melanoma: An analysis of 33,384 patients in the german central malignant melanoma registry. J Am Acad Dermatol 2012;66:37–45. PMID:21700361 - PubMed

[10] Leiter U, Buettner PG, Eigentler TK, Brocker EB, Voit C, Gollnick H, Marsch W, Wollina U, Meier F, Garbe C. Hazard rates for recurrent and secondary cutaneous melanoma: An analysis of 33,384 patients in the german central malignant melanoma registry. J Am Acad Dermatol 2012;66:37–45. PMID:21700361 - PubMed

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Randomized controlled trial of the mySmartSkin web-based intervention to promote skin self-examination and sun protection behaviors among individuals diagnosed with melanoma: study design and baseline characteristics

Affiliations

Randomized controlled trial of the mySmartSkin web-based intervention to promote skin self-examination and sun protection behaviors among individuals diagnosed with melanoma: study design and baseline characteristics

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