Reducing Skin Cancer Risk in Childhood Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 726
- 试验地点
- 2
- 主要终点
- Patient thorough skin self-examination (TSSE)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •personal history of a skin cancer diagnosis
研究组 & 干预措施
Patient activation and education
Patient activation and education (PAE)
干预措施: Patient activation and education (PAE) (Behavioral)
PAE plus physician activation
PAE plus physician activation (PAE + MD)
干预措施: PAE plus physician activation (PAE + MD) (Behavioral)
PAE, MD, plus teledermoscopy
PAE physician activation, plus teledermoscopy (PAE +MD +TD)
干预措施: PAE physician activation, plus teledermoscopy (PAE +MD +TD) (Behavioral)
结局指标
主要结局
Patient thorough skin self-examination (TSSE)
时间窗: 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.
次要结局
- Completion of a physician skin exam(18 months)
- Shorter time interval to diagnostic visit(18 months)
研究者
Alan Geller
RN, MPH
Harvard School of Public Health (HSPH)
