Clinical trial NCT02046811: Reducing Skin Cancer Risk in Childhood Cancer Survivors
Official title: Reducing Skin Cancer Risk in Childhood Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Neoplasms
Keywords: Skin neoplasms
Radiation
Screening
Self-examination
Comparative effectiveness research
Dermoscopy
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: St. Jude Children's Research Hospital
name: Dana-Farber Cancer Institute
name: Memorial Sloan Kettering Cancer Center
name: Emory University
First posted: 2014-01-28
Enrollment: 726
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Eligibility 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

Primary outcomes:
measure: Patient thorough skin self-examination (TSSE)
timeFrame: 18 months
Secondary outcomes:
measure: Completion of a physician skin exam
timeFrame: 18 months
measure: Shorter time interval to diagnostic visit
timeFrame: 18 months
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Alan Geller, RN, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.