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A Comparison of Interventions to Teach Melanoma Patients Skin Self-examination

2016年7月10日 更新者:June Robinson、Northwestern University
The almost 724,000 Americans survivors of melanoma are estimated to have 4 first degree relatives per case; thus, 2.8 million Americans are at increased risk of developing melanoma in comparison to the general public. Skin self-examination (SSE) with the assistance of a partner by these individuals could improve survival. If effective, the workbook tested in this proposal could be distributed to people at risk of developing melanoma by large scale means in physicians office.

研究概览

详细说明

Population based registries document that survival from melanoma, a growing public health problem with approximately 70,000 new melanoma cases and an estimated 8,600 deaths in 2010, is dependent on the thickness of the melanoma. By facilitating seeking medical care, skin self-examinations (SSEs) by individuals with a prior history of melanoma, who are at risk to develop subsequent melanomas, may lead to the early detection and treatment of melanoma when it is usually more effective. Thus, further research that enhances early detection is warranted and our application directly tests novel methods of training high-risk melanoma patients and their partners on how to conduct SSEs to promote early detection. Our proposed research builds upon the strengths of the R21 that: a) established that in-person training to conduct SSE with a partner significantly enhanced SSE performance 4 months after the intervention, and b) developed and pilot tested a manualized take-home workbook training approach (WORKBOOK). Our pilot work on the WORKBOOK with partners suggests that patient-partner dyads (n = 21) perceived it to be readable, useful, and in the short term 4 month follow-up, empirically equivalent in promoting SSE knowledge, skills, and behaviors compared with patient-partner dyads in the in-person partner training condition (n = 19). Our proposed research builds on our NCI funded studies by conducting a formal examination with 430 pairs (860 subjects) randomized to either the in-person or workbook training vs. an assessment only control group that receives standard of care over a 2 year longitudinal study with 4 month interval evaluations. An additional group of 70 pairs (140 subjects) has been added to test a tablet computer-based program.

Our proposed research directly tests novel methods of training Stage I and IIB melanoma patients, who have a 5 year survival of 80-90%, and their partners, on how to conduct SSEs. We will compare the efficacy of the in-person training vs. workbook for patients and partners vs. controls on SSE knowledge/skill acquisition and retention, and SSE performance and accuracy on a short (4 and 8 months post baseline) and long term basis (12, 16, 20, and 24 months post baseline) and examine whether partner-patient relationship-qualities moderate the relationship between the training approaches and SSEs knowledge/skill acquisition and retention, and SSE performance and accuracy. The tablet computer-based program will also be tested for efficacy and compared with the previous groups.

Establishing health promotion partnerships is important to those at risk to develop melanoma because SSE is difficult to successfully perform as an individual. It is expected that the workbook will promote SSE at least as well as and perhaps better than in-person training and become an easily disseminated SSE training approach that is not dependent on the time and teaching skills of the non-MD clinical office staff.

研究类型

介入性

注册 (实际的)

1000

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

    • Illinois
      • Chicago、Illinois、美国、60611
        • Northwestern University Department of Dermatology

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 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Personal history of Stage 0 through IIB melanoma
  2. At least 6 weeks post surgical treatment of Stage 0 through IIA melanoma
  3. Age 18-80 years old
  4. Have sufficient vision to read a newspaper in order to visually detect changes on skin
  5. Able to read English
  6. Have a partner willing to participate in skin checks

Exclusion Criteria:

1.Subjects overburdened with other co- morbid diseases, medical treatments (e.g. chemotherapy), unable to participate in a conversation at a sixth grade language level due to cognitive impairment (e.g. by a stroke), or prior participation in SSE research.

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:放映
  • 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
有源比较器:In-person Counseling and Education
In the in-person training the Research Assistant demonstrates the use of a mm ruler, a lighted magnifying lens, a set of body maps and a scorecard, 4 pens, ABCDE rule on the skin exam card and discusses the ABCDE rule by pointing to the color examples on the skin exam card. 165 pairs (330 subjects) are randomized to this arm.
The design is a 3 [in-person training of patients and partners (PARTNER) vs. workbook training of patients and partners (WORKBOOK) vs. an assessment only group that receives education and treatment as usual care] X 7 [baseline, 4, 8, 12, 16, 20, and 24 month follow-up] study. Standard education of melanoma patients, which are to be performed with the study partner, includes a recommendation to check moles and mark ones to remember on a body map. All participants receive the same measures and will be recruited using the same procedures, thus, yielding equivalence across conditions. Pairs will observe how to use their skin check tools and be asked to demonstrate their competence in using them.
有源比较器:Workbook
The workbook, which includes all of the information delivered in the in-person intervention, is 39 pages in length, and has 76 color figures. Each element of the in-person training represents a chapter in the workbook. The introduction explores the partners' understanding of melanoma and their personal risk of developing another melanoma, and attitudes about the benefit of early detection assisted by a partner. The early detection segment uses a skin diagram to illustrate the difference between thin and thick melanoma and presents the treatment based on the depth of the melanoma. 165 pairs (330 subjects) are randomized to this arm.
Participants will read a workbook and perform skills training exercises.
无干预:Control
Education and counseling as usually delivered in clinical practice. 100 pairs (200 subjects) are randomized to this arm.
有源比较器:Tablet Computer-Based Education
Education will be given by an interactive tablet app. Each pair will view video recordings of certain parts of the in-person presentation as well as select slides from the in-person PowerPoint presentation. Parts of the workbook will be incorporated as well. 70 pairs (140 subjects) are randomized into this arm.
Participants will receive their education from an interactive app designed for a tablet computer.

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
Self-Efficacy in Performing SSE
大体时间:24 months
To compare the self-efficacy of the in-person training vs. workbook for patients and partners by self-report on a survey at 4-month intervals over 24 months.
24 months

次要结果测量

结果测量
措施说明
大体时间
Accuracy
大体时间:24 months
Accurate identification of concerning lesions (melanoma) by participants performing SSE in comparison with the dermatologist's assessment.
24 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。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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

2011年9月1日

初级完成 (实际的)

2015年5月1日

研究完成 (实际的)

2015年5月1日

研究注册日期

首次提交

2011年8月15日

首先提交符合 QC 标准的

2011年9月12日

首次发布 (估计)

2011年9月13日

研究记录更新

最后更新发布 (估计)

2016年7月12日

上次提交的符合 QC 标准的更新

2016年7月10日

最后验证

2016年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

publication of results with listing in My NCBI

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.

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