Reducing Skin Cancer Risk in Childhood Cancer Survivors

Skin Neoplasms Clinical Trial

Official title:

Reducing Skin Cancer Risk in Childhood Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046811
• Other study ID #: 1R01CA175231
• Secondary ID: R01CA175231
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: January 1, 2018

Study information

• Verified date: June 2018
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 726
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Neoplasms

Intervention

Behavioral:
• Patient activation and education (PAE)
Text messaging and web-based tutorials for a 12-month duration (a website and smartphone interface)
• 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
• 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

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (6)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient thorough skin self-examination (TSSE)	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.	18 months
Secondary	Completion of a physician skin exam	Completion of a physician skin exam will be assessed by participant report and chart review.	18 months
Secondary	Shorter time interval to diagnostic visit	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.	18 months