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Completed

NCT Number: NCT02046811

Reducing Skin Cancer Risk in Childhood Cancer Survivors

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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient activation and education (PAE)

Behavioral

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

PAE plus physician activation (PAE + MD)

Behavioral

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

PAE physician activation, plus teledermoscopy (PAE +MD +TD)

Behavioral

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • Dana-Farber Cancer Institute
  • Emory University
  • Memorial Sloan Kettering Cancer Center
  • National Cancer Institute (NCI)
  • St. Jude Children's Research Hospital

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 28, 2014
Registry last updated
Jun 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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