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临床试验/NCT00394134
NCT00394134已完成不适用

A Targeted, Family-Focused Intervention for Melanoma Prevention

M.D. Anderson Cancer Center2 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2005年4月最近更新:
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
205
试验地点
2
主要终点
Patients'and Children's Sun Exposure and Protective Practices <Patient Interview Responses>

研究概览

简要总结

In this study, the researchers will conduct interviews with melanoma patients to describe the sun exposure and sun protection practices of patients and their children. The researchers will use the findings of this interview study to develop a salient intervention targeted to the needs of melanoma patients and their children. The researchers will evaluate the intervention in a randomized, controlled trial.

The specific aims of this study are:

  • To interview 210 melanoma patients with children 12 years of age or younger to describe patients' socio-cognitive and psychological factors, describe patients' and children's sun exposure and sun protection practices, and identify determinants of patients' and children's sun exposure and protective practices.
  • To develop a targeted behavioral intervention that is designed to increase patients' protective practices to reduce their children's sun exposure, increase patients' self-protective practices, decrease the sun exposure levels of patients and their children, and positively influence socio-cognitive and psychological determinants of child-centered and self-protective practices.
  • To conduct a randomized, controlled trial in a sample of 360 melanoma patients with children 12 years of age or younger to evaluate the targeted behavioral intervention consisting of print and video materials. The intervention will be assessed for its effects on: 1) child sun exposure and sun protection; 2) patients' protective practices to reduce their children's sun exposure; 3) patients' sun exposure and self-protective practices; and 4) patients' socio-cognitive and psychological factors that facilitate behavior change.

详细描述

Research is to learn about awareness, attitudes, and behaviors related to sun exposure, sun protection, skin examination, and other risk-reducing behaviors. The results of this study will be used to design an educational program on sun protection for persons who have had melanoma and their children.

The study will involve a telephone interview that will last about 45 minutes and will be scheduled at your convenience. Your participation in this study is completely voluntary and you may refuse to participate. Your decision about participating will not affect the care or services you or your family may receive at The University of Texas M. D. Anderson Cancer Center.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Melanoma patients are eligible if they were diagnosed with in situ, localized, or microscopic stage III melanoma after January 1,
  • Melanoma patients are eligible if they are the parent of a child 12 years of age or younger and reside with the child.
  • Melanoma patients are eligible if they provide informed consent.
  • Melanoma patients are eligible if they are 18 years of age or older.
  • Melanoma patients are eligible if they are able to speak, read, and write English.
  • Melanoma patients are eligible if they meet all inclusion criteria.

排除标准

  • Melanoma patients are not eligible if they cannot provide informed consent.

研究组 & 干预措施

Interview

Other

Interviews to describe the sun exposure and sun protection practices of patients and their children.

干预措施: Interview (Behavioral)

结局指标

主要结局

Patients'and Children's Sun Exposure and Protective Practices <Patient Interview Responses>

时间窗: Baseline Interview, 6 Month and 9 Month Interviews

Standard descriptive statistics computed for measures administered during structured interview, including means, standard deviations, ranges, measures of skew and kurtosis, together with 95% confidence intervals. Distributional characteristics of variables closely examined using boxplots, histograms, quantile-quantile plots, and the Kolmogorov-Smirnov test of normality. General linear mixed-model approach used evaluate associations between patient socio-cognitive factors, psychological factors, phenotypic characteristics, and demographic characteristics; child phenotypic and demographic characteristics; and practices of participants to reduce their children's sun exposure, self-protective practices of participants, and sun exposure practices of children and participants.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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