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Evaluation Study of SPOTme® Skin Cancer Screenings

2019年8月12日 更新者:Alan Geller、Harvard School of Public Health (HSPH)
This study evaluates the impact of the AAD SPOTme® skin cancer screening events on attendees' skin cancer prevention and detection behaviors. This study will also evaluate whether an educational intervention will improve post-screening engagement of attendees with dermatologists.

研究概览

详细说明

Despite tremendous growth in both the interest and volume of skin cancer screenings at the national level, the actual utility and impact of the AAD SPOT me™ skin cancer screening programs have not been fully evaluated. This study will address this knowledge gap. Early detection is vital in the fight against skin cancer, the most common cancer in the United States. While the effects of skin cancer can be devastating, this disease is highly treatable when detected early.

This study evaluates the impact of the AAD SPOTme® skin cancer screening events on attendees' skin cancer prevention and detection behaviors. This study will also evaluate whether an educational intervention will improve post-screening engagement of attendees with dermatologists.

研究类型

介入性

注册 (实际的)

431

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Harvard TH Chan School of Public Health

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Participated in the American Academy of Dermatology national screening program in 2016 or 2017
  • Have a presumptive diagnosis (screening, non-confirmed) of melanoma
  • Have provided the AAD with permission to be re-contacted
  • Have provided the AAD with an email address
  • Aged 18 years or older
  • Able to read English

Exclusion Criteria:

  • None

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention Arm 1
Individuals randomized to intervention group 1 will have participated in the AAD SPOTmeⓇ skin cancer screening program in either 2016 or 2017 AND will receive additional skin cancer screening educational materials.
Individuals randomized to the intervention group will receive skin cancer screening educational materials.
All study participants will have participated in the AAD SPOTmeⓇ skin cancer screening program in either 2016 or 2017.
实验性的:Intervention Arm 2
Individuals randomized to intervention group 2 will have participated in the AAD SPOTmeⓇ skin cancer screening program in either 2016 or 2017 only.
All study participants will have participated in the AAD SPOTmeⓇ skin cancer screening program in either 2016 or 2017.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Completion of a physician skin examination
大体时间:Baseline
Self-report of a physician skin examination will be defined as a health care provider examining the patient's entire body for any sign of skin cancer during the period following patient's receipt of an AAD SPOTme® skin cancer screening to the baseline assessment.
Baseline

次要结果测量

结果测量
措施说明
大体时间
Completion of a physician skin examination
大体时间:6 months
Self-report of a physician skin examination will be defined as a health care provider examining the patient's entire body for any sign of skin cancer during the 3 months prior to the 6-month follow up assessment
6 months
Patient thorough skin self-examination (TSSE)
大体时间:6 months
Self-report of patient thorough skin self-examination (TSSE) will be defined as performing at least one TSSE during the 3 months prior to the 6-month follow up assessment
6 months
Patient attitude towards sun protection
大体时间:6 months
Self-report of patient attitude towards use of sun protection will be defined by likelihood of engaging in sun protection practices in the year following the 6-month follow up assessment
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Alan Geller, MPH, RN、Harvard TH Chan School of Public Health

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年12月1日

初级完成 (实际的)

2018年10月1日

研究完成 (实际的)

2019年6月1日

研究注册日期

首次提交

2017年12月6日

首先提交符合 QC 标准的

2018年6月19日

首次发布 (实际的)

2018年6月21日

研究记录更新

最后更新发布 (实际的)

2019年8月13日

上次提交的符合 QC 标准的更新

2019年8月12日

最后验证

2019年8月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 17-1668

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Intervention Arm的临床试验

3
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