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Reducing Skin Cancer Risk in Childhood Cancer Survivors

Reducing Skin Cancer Risk in Childhood Cancer Survivors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02046811
Enrollment
726
Registered
2014-01-28
Start date
2015-03-31
Completion date
2018-01-01
Last updated
2018-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Neoplasms

Keywords

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

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.

Interventions

BEHAVIORALPatient activation and education (PAE)

Text messaging and web-based tutorials for a 12-month duration (a website and smartphone interface)

BEHAVIORALPAE 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

BEHAVIORALPAE 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

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
St. Jude Children's Research Hospital
CollaboratorOTHER
Dana-Farber Cancer Institute
CollaboratorOTHER
Memorial Sloan Kettering Cancer Center
CollaboratorOTHER
Emory University
CollaboratorOTHER
Harvard School of Public Health (HSPH)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient thorough skin self-examination (TSSE)18 monthsSelf-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

MeasureTime frameDescription
Completion of a physician skin exam18 monthsCompletion of a physician skin exam will be assessed by participant report and chart review.
Shorter time interval to diagnostic visit18 monthsA 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026