Reducing Skin Cancer Risk in Childhood Cancer Survivors

• ClinicalTrials.gov Identifier: NCT02046811
• Recruitment Status: Completed
• First Posted: January 28, 2014
• Last Update Posted: June 20, 2018
• Sponsor: Harvard School of Public Health (HSPH)
• Collaborators: National Cancer Institute (NCI); St. Jude Children's Research Hospital; Dana-Farber Cancer Institute; Memorial Sloan Kettering Cancer Center; Emory University
• Information provided by (Responsible Party): Alan Geller, Harvard School of Public Health (HSPH)

Study Description

Brief Summary:

The objective of this study is to determine the impact of a 12-month patient activation and education intervention on skin cancer early detection practices among childhood cancer survivors treated with radiation. This randomized controlled trial uses a three-group design.

Our specific aims are to: (1) Determine the impact of a Patient Activation and Education intervention with and without physician activation and teledermatology on skin cancer early detection practices, (2) Determine the impact of the intervention on time to diagnosis, and (3) Estimate the cost and cost-effectiveness of the intervention as a secondary outcome.

Condition or disease	Intervention/treatment	Phase
Skin Neoplasms	Behavioral: Patient activation and education (PAE); Behavioral: PAE plus physician activation (PAE + MD); Behavioral: PAE physician activation, plus teledermoscopy (PAE +MD +TD)	Not Applicable

Detailed Description:

There are currently more than 420,000 Americans who are long-term survivors of childhood and adolescent cancer. While these groups have greatly benefited from recent medical advances, primarily increasing overall survival rates, treatment advances have come at a cost. It is now clear that childhood radiation therapy has caused survivors to be at extremely high risk for non-melanoma skin cancer (NMSC) and increased risk of melanoma. Early detection is crucial to reduce the morbidity caused by NMSCs and the morbidity and mortality incurred due to melanoma. Both patient and provider action are needed to detect and treat early skin cancers and to find new solutions to ensure expedited follow-up care and treatment, especially among those who live where they have little access to dermatologists.

The objective of this study is to determine the impact of a 12-month patient activation and education intervention on skin cancer early detection practices among childhood cancer survivors treated with radiation. All participants will receive text messages encouraging them to examine their skin and request physician examinations while concurrently driving them to a study website that provides education related to the associated skills, and reinforces and expands the text messages. To reduce skin cancers among this young and dispersed patient population, this study will address several key issues: (1) how to provide patients with the skills needed to conduct effective skin self-examinations; 2) how to prompt action from patient's physicians when worrisome moles and lesions are found; and 3) how to ensure rapid access to dermatologic exams, which in some parts of the US can take weeks or months to schedule.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 726 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Screening
• Official Title: Reducing Skin Cancer Risk in Childhood Cancer Survivors
• Actual Study Start Date: March 2015
• Actual Primary Completion Date: January 1, 2018
• Actual Study Completion Date: January 1, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Patient activation and education; Patient activation and education (PAE)	Behavioral: Patient activation and education (PAE); Text messaging and web-based tutorials for a 12-month duration (a website and smartphone interface)
Experimental: PAE plus physician activation; PAE plus physician activation (PAE + MD)	Behavioral: PAE plus physician activation (PAE + MD); Text messaging and web-based tutorials for a 12-month duration (a website and smartphone interface), physician activation/educational materials about: (1) survivors' increased skin cancer risk; (2) the benefits of and the skills needed to conduct full-body skin exams; and (3) the importance of recommending routine SSE to patients
Experimental: PAE, MD, plus teledermoscopy; PAE physician activation, plus teledermoscopy (PAE +MD +TD)	Behavioral: PAE physician activation, plus teledermoscopy (PAE +MD +TD); Text messaging and web-based tutorials for a 12-month duration (a website and smartphone interface), physician activation/educational materials about: (1) survivors' increased skin cancer risk; (2) the benefits of and the skills needed to conduct full-body skin exams; and (3) the importance of recommending routine SSE to patients, and participant receipt of a dermoscopic lens

Outcome Measures

Primary Outcome Measures :

1. Patient thorough skin self-examination (TSSE) [ Time Frame: 18 months ]
   Self-report of patient thorough skin self-examination (TSSE) will be defined as performing at least one TSSE during the 2 months prior to the 18-month follow-up assessment.

Secondary Outcome Measures :

1. Completion of a physician skin exam [ Time Frame: 18 months ]
   Completion of a physician skin exam will be assessed by participant report and chart review.
2. Shorter time interval to diagnostic visit [ Time Frame: 18 months ]
   A shorter time interval between the first finding of a suspect lesion after randomization and a diagnostic visit will be assessed by participant report and chart review.

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• treated with radiation for a childhood cancer
• have a regular healthcare provider whom he/she has seen in the previous 2 years, or plans to see in the next year
• have a phone that can receive text messages
• have access to a dermlite compatible smartphone or tablet

Exclusion Criteria:

• personal history of a skin cancer diagnosis

Contacts and Locations

Locations

United States, Tennessee

St. Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Sponsors and Collaborators

Harvard School of Public Health (HSPH)

National Cancer Institute (NCI)

St. Jude Children's Research Hospital

Dana-Farber Cancer Institute

Memorial Sloan Kettering Cancer Center

Emory University

Investigators

• Principal Investigator: Alan Geller, RN, MPH; Harvard School of Public Health (HSPH)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Daniel CL, Armstrong GT, Keske RR, Davine JA, McDonald AJ, Sprunck-Harrild KM, Coleman C, Haneuse SJ, Mertens AC, Emmons KM, Marghoob AA, Elkin EB, Dusza SW, Robison LL, Geller AC. Advancing Survivors' Knowledge (ASK) about skin cancer study: study protocol for a randomized controlled trial. Trials. 2015 Mar 24;16:109. doi: 10.1186/s13063-015-0637-x.

• Responsible Party: Alan Geller, RN, MPH, Harvard School of Public Health (HSPH)
• ClinicalTrials.gov Identifier: NCT02046811
• Other Study ID Numbers: 1R01CA175231 ( U.S. NIH Grant/Contract ); R01CA175231 ( U.S. NIH Grant/Contract )
• First Posted: January 28, 2014
• Last Update Posted: June 20, 2018
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Alan Geller, Harvard School of Public Health (HSPH):

Skin neoplasms; Radiation; Screening; Self-examination; Comparative effectiveness research; Dermoscopy

Additional relevant MeSH terms:

Skin Neoplasms; Neoplasms; Neoplasms by Site; Skin Diseases