Advancing Survivors' Knowledge (ASK) about skin cancer study: study protocol for a randomized controlled trial

doi:10.1186/s13063-015-0637-x

Randomized Controlled Trial

. 2015 Mar 24:16:109.

doi: 10.1186/s13063-015-0637-x.

Advancing Survivors' Knowledge (ASK) about skin cancer study: study protocol for a randomized controlled trial

Affiliations

¹ Department of Social and Behavioral Sciences, Harvard TH Chan School of Public Health, 677 Huntington Avenue, Kresge 718, 02115-6028, Boston, MA, USA. casey_daniel@dfci.harvard.edu.
² Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, 262 Danny Thomas Place, MS 735, 38105-3678, Memphis, TN, USA. greg.armstrong@stjude.org.
³ Department of Social and Behavioral Sciences, Harvard TH Chan School of Public Health, 677 Huntington Avenue, Kresge 718, 02115-6028, Boston, MA, USA. rkeske@hsph.harvard.edu.
⁴ Department of Social and Behavioral Sciences, Harvard TH Chan School of Public Health, 677 Huntington Avenue, Kresge 718, 02115-6028, Boston, MA, USA. jdavine@hsph.harvard.edu.
⁵ Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, 262 Danny Thomas Place, MS 735, 38105-3678, Memphis, TN, USA. aaron.mcdonald@stjude.org.
⁶ Department of Medical Oncology, Dana-Farber Cancer Institute, 450 Brookline Ave, LW601, 02215-5450, Boston, MA, USA. kim_sprunckharrild@dfci.harvard.edu.
⁷ Department of Population Sciences, Dana-Farber Cancer Institute, 450 Brookline Avenue, 02215-5450, Boston, MA, USA. catherine_coleman@dfci.harvard.edu.
⁸ Department of Biostatistics, Harvard TH Chan School of Public Health, 655 Huntington Avenue, Bldg 2, Rm 451, 02115-6009, Boston, MA, USA. shaneuse@hsph.harvard.edu.
⁹ Department of Pediatrics, Emory University, Emory Children's Center, 2015 Uppergate Drive, 4th floor, 30322-1014, Atlanta, GA, USA. ann.mertens@choa.org.
¹⁰ Kaiser Permanente, 1800 Harrison Street, 16th Floor, #161R03, 94612-3463, Oakland, CA, USA. karen.m.emmons@kp.org.
¹¹ Memorial-Sloan Kettering Cancer Center, 1275 York Ave, 10065-6007, New York, NY, USA. marghooa@mskcc.org.
¹² Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, Box 44, 10065-6007, New York, NY, USA. elkine@mskcc.org.
¹³ Department of Medicine, Memorial Sloan-Kettering Cancer Center, 160 East 53rd St, 2nd Floor, 10022-5243, New York, NY, USA. duszas@mskcc.org.
¹⁴ Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, 262 Danny Thomas Place, MS 735, 38105-3678, Memphis, TN, USA. les.robison@stjude.org.
¹⁵ Department of Social and Behavioral Sciences, Harvard TH Chan School of Public Health, 677 Huntington Avenue, Kresge 718, 02115-6028, Boston, MA, USA. ageller@hsph.harvard.edu.

PMID: 25873142
PMCID: PMC4392639
DOI: 10.1186/s13063-015-0637-x

Randomized Controlled Trial

Advancing Survivors' Knowledge (ASK) about skin cancer study: study protocol for a randomized controlled trial

Casey L Daniel et al. Trials. 2015.

. 2015 Mar 24:16:109.

doi: 10.1186/s13063-015-0637-x.

Authors

Affiliations

¹ Department of Social and Behavioral Sciences, Harvard TH Chan School of Public Health, 677 Huntington Avenue, Kresge 718, 02115-6028, Boston, MA, USA. casey_daniel@dfci.harvard.edu.
² Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, 262 Danny Thomas Place, MS 735, 38105-3678, Memphis, TN, USA. greg.armstrong@stjude.org.
³ Department of Social and Behavioral Sciences, Harvard TH Chan School of Public Health, 677 Huntington Avenue, Kresge 718, 02115-6028, Boston, MA, USA. rkeske@hsph.harvard.edu.
⁴ Department of Social and Behavioral Sciences, Harvard TH Chan School of Public Health, 677 Huntington Avenue, Kresge 718, 02115-6028, Boston, MA, USA. jdavine@hsph.harvard.edu.
⁵ Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, 262 Danny Thomas Place, MS 735, 38105-3678, Memphis, TN, USA. aaron.mcdonald@stjude.org.
⁶ Department of Medical Oncology, Dana-Farber Cancer Institute, 450 Brookline Ave, LW601, 02215-5450, Boston, MA, USA. kim_sprunckharrild@dfci.harvard.edu.
⁷ Department of Population Sciences, Dana-Farber Cancer Institute, 450 Brookline Avenue, 02215-5450, Boston, MA, USA. catherine_coleman@dfci.harvard.edu.
⁸ Department of Biostatistics, Harvard TH Chan School of Public Health, 655 Huntington Avenue, Bldg 2, Rm 451, 02115-6009, Boston, MA, USA. shaneuse@hsph.harvard.edu.
⁹ Department of Pediatrics, Emory University, Emory Children's Center, 2015 Uppergate Drive, 4th floor, 30322-1014, Atlanta, GA, USA. ann.mertens@choa.org.
¹⁰ Kaiser Permanente, 1800 Harrison Street, 16th Floor, #161R03, 94612-3463, Oakland, CA, USA. karen.m.emmons@kp.org.
¹¹ Memorial-Sloan Kettering Cancer Center, 1275 York Ave, 10065-6007, New York, NY, USA. marghooa@mskcc.org.
¹² Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, Box 44, 10065-6007, New York, NY, USA. elkine@mskcc.org.
¹³ Department of Medicine, Memorial Sloan-Kettering Cancer Center, 160 East 53rd St, 2nd Floor, 10022-5243, New York, NY, USA. duszas@mskcc.org.
¹⁴ Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, 262 Danny Thomas Place, MS 735, 38105-3678, Memphis, TN, USA. les.robison@stjude.org.
¹⁵ Department of Social and Behavioral Sciences, Harvard TH Chan School of Public Health, 677 Huntington Avenue, Kresge 718, 02115-6028, Boston, MA, USA. ageller@hsph.harvard.edu.

PMID: 25873142
PMCID: PMC4392639
DOI: 10.1186/s13063-015-0637-x

Abstract

Background: Advances in treatment have increased childhood cancer 5-year survival rates to greater than 80%. However, children previously treated with radiation are at significantly increased risk of developing subsequent neoplasms, the most common of which are skin cancers. The National Cancer Institute and Children's Oncology Group have issued recommendations for survivors treated with radiation to perform monthly skin self-examinations and receive a physician skin examination at least annually, as early detection has demonstrated markedly improved outcomes in the diagnosis and treatment of skin cancers. The goal of the present study is to increase rates of skin self-examinations and clinical skin examinations among adult survivors of childhood cancer treated with radiation.

Methods/design: This randomized controlled trial uses a 3-group comparative effectiveness design comparing: (1) Patient Activation and Education (PAE) including text messaging, print and web-based tutorials over 12 months; (2) PAE plus physician activation (PAE + MD) adding physician activation/educational materials about survivors' increased skin cancer risk and conducting full-body skin exams; and (3) PAE plus physician activation, plus teledermoscopy (PAE + MD + TD) adding participant receipt of a dermatoscope intended to empower them to photograph suspect moles or lesions for review by the study dermatologist.

Discussion: The current study addresses barriers to screening in this population by providing educational and motivational information for both survivors and physicians regarding the value of periodic skin examinations. It also utilizes innovative mobile health technology to encourage and motivate (that is activate) survivors to conduct skin self-examinations, request physician exams, and obtain treatment when worrisome lesions are found. Finally, as a comparative effectiveness trial, this study isolates the effects of adding specific components to the patient activation intervention to test the most effective intervention for enhancing skin examination vigilance among this high-risk group.

Trial registration: Clinicaltrials.gov: NCT02046811 ; Registration date: 22 January 2014.

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Figures

**Figure 1**
**Study design overview for the three intervention arms.**

**Figure 2**
**DermLite lens attachment by 3Gen.**

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References

1. SEER Cancer Statistics Review. 1975–2010. http://seer.cancer.gov/csr/1975_2010/. Accessed 10 November 2014.
1. Robison LL, Hudson MM. Survivors of childhood and adolescent cancer: life-long risks and responsibilities. Nat Rev Cancer. 2014;14:61–70. doi: 10.1038/nrc3634. - DOI - PMC - PubMed
1. Oeffinger KC, Mertens AC, Sklar CA, Kawashima T, Hudson MM, Meadows AT, et al. Chronic health conditions in adult survivors of childhood cancer. N Engl J Med. 2006;355:1572–82. doi: 10.1056/NEJMsa060185. - DOI - PubMed
1. Hudson MM, Ness KK, Gurney JG, Mulrooney DA, Chemaitilly W, Krull KR, et al. Clinical ascertainment of health outcomes among adults treated for childhood cancer. JAMA. 2013;309:2371–81. doi: 10.1001/jama.2013.6296. - DOI - PMC - PubMed
1. Landier W, Bhatia S, Eshelman DA, Forte KJ, Sweeney T, Hester AL, et al. Development of risk-based guidelines for pediatric cancer survivors: the Children’s Oncology Group Long-Term Follow-Up Guidelines from the Children’s Oncology Group Late Effects Committee and Nursing Discipline. J Clin Oncol. 2004;22:4979–90. doi: 10.1200/JCO.2004.11.032. - DOI - PubMed

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[1] SEER Cancer Statistics Review. 1975–2010. http://seer.cancer.gov/csr/1975_2010/. Accessed 10 November 2014.

[2] SEER Cancer Statistics Review. 1975–2010. http://seer.cancer.gov/csr/1975_2010/. Accessed 10 November 2014.

[3] Robison LL, Hudson MM. Survivors of childhood and adolescent cancer: life-long risks and responsibilities. Nat Rev Cancer. 2014;14:61–70. doi: 10.1038/nrc3634. - DOI - PMC - PubMed

[4] Robison LL, Hudson MM. Survivors of childhood and adolescent cancer: life-long risks and responsibilities. Nat Rev Cancer. 2014;14:61–70. doi: 10.1038/nrc3634. - DOI - PMC - PubMed

[5] Oeffinger KC, Mertens AC, Sklar CA, Kawashima T, Hudson MM, Meadows AT, et al. Chronic health conditions in adult survivors of childhood cancer. N Engl J Med. 2006;355:1572–82. doi: 10.1056/NEJMsa060185. - DOI - PubMed

[6] Oeffinger KC, Mertens AC, Sklar CA, Kawashima T, Hudson MM, Meadows AT, et al. Chronic health conditions in adult survivors of childhood cancer. N Engl J Med. 2006;355:1572–82. doi: 10.1056/NEJMsa060185. - DOI - PubMed

[7] Hudson MM, Ness KK, Gurney JG, Mulrooney DA, Chemaitilly W, Krull KR, et al. Clinical ascertainment of health outcomes among adults treated for childhood cancer. JAMA. 2013;309:2371–81. doi: 10.1001/jama.2013.6296. - DOI - PMC - PubMed

[8] Hudson MM, Ness KK, Gurney JG, Mulrooney DA, Chemaitilly W, Krull KR, et al. Clinical ascertainment of health outcomes among adults treated for childhood cancer. JAMA. 2013;309:2371–81. doi: 10.1001/jama.2013.6296. - DOI - PMC - PubMed

[9] Landier W, Bhatia S, Eshelman DA, Forte KJ, Sweeney T, Hester AL, et al. Development of risk-based guidelines for pediatric cancer survivors: the Children’s Oncology Group Long-Term Follow-Up Guidelines from the Children’s Oncology Group Late Effects Committee and Nursing Discipline. J Clin Oncol. 2004;22:4979–90. doi: 10.1200/JCO.2004.11.032. - DOI - PubMed

[10] Landier W, Bhatia S, Eshelman DA, Forte KJ, Sweeney T, Hester AL, et al. Development of risk-based guidelines for pediatric cancer survivors: the Children’s Oncology Group Long-Term Follow-Up Guidelines from the Children’s Oncology Group Late Effects Committee and Nursing Discipline. J Clin Oncol. 2004;22:4979–90. doi: 10.1200/JCO.2004.11.032. - DOI - PubMed

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Advancing Survivors' Knowledge (ASK) about skin cancer study: study protocol for a randomized controlled trial

Affiliations

Advancing Survivors' Knowledge (ASK) about skin cancer study: study protocol for a randomized controlled trial

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