Reducing Skin Cancer Risk in Childhood Cancer Survivors

Not Applicable

Completed

• Conditions: Skin Neoplasms
• Interventions: Behavioral: PAE plus physician activation (PAE + MD); Behavioral: PAE physician activation, plus teledermoscopy (PAE +MD +TD); Behavioral: Patient activation and education (PAE)

• Registration Number: NCT02046811
• Lead Sponsor: Harvard School of Public Health (HSPH)

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.

Study Timeline

• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-24
• Study First Posted: 2014-01-28
• Study Start: 2015-03
• Primary Completion: 2018-01-01
• Study Completion: 2018-01-01
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-19
• Last Update Posted: 2018-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 726

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PAE plus physician activation	PAE plus physician activation (PAE + MD)	PAE plus physician activation (PAE + MD)
PAE, MD, plus teledermoscopy	PAE physician activation, plus teledermoscopy (PAE +MD +TD)	PAE physician activation, plus teledermoscopy (PAE +MD +TD)
Patient activation and education	Patient activation and education (PAE)	Patient activation and education (PAE)

Primary Outcome Measures

Name	Time	Method
Patient thorough skin self-examination (TSSE)	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

Name	Time	Method
Completion of a physician skin exam	18 months	Completion of a physician skin exam will be assessed by participant report and chart review.
Shorter time interval to diagnostic visit	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.

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States