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临床试验/NCT01432860
NCT01432860已完成不适用

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

Northwestern University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2011年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,000
试验地点
1
主要终点
Self-Efficacy in Performing SSE

研究概览

简要总结

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.

详细描述

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 (Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

In-person Counseling and Education

Active Comparator

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.

干预措施: In-person counseling (Behavioral)

Workbook

Active Comparator

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.

干预措施: Workbook (Behavioral)

Control

No Intervention

Education and counseling as usually delivered in clinical practice. 100 pairs (200 subjects) are randomized to this arm.

Tablet Computer-Based Education

Active Comparator

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.

干预措施: Tablet Computer-Based Education (Behavioral)

结局指标

主要结局

Self-Efficacy in Performing SSE

时间窗: 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.

次要结局

  • Accuracy(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

June Robinson

Professor of Dermatology

Northwestern University

研究点 (1)

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