此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Promoting Early Detection of Melanoma During the Mammography Experience

2017年10月6日 更新者:June Robinson、Northwestern University

The proposed study is a pilot and feasibility study designed to develop materials to enhance early detection of melanomas among women at risk to develop melanoma due to indoor tanning, having a family history of melanoma or a personal history of melanoma.

The hypothesis of this study is that women, who are engaged in health promotion by having mammograms, will be able to assess the personal relevance of skin self-examination (SSE), be interested in learning about SSE and able to implement SSE while they are partially disrobed in the privacy of the changing room in the mammogram facility.

研究概览

详细说明

After patients complete the mammogram, they return to the changing room and put on their clothing. After exiting the changing room in the Lynn Sage Comprehensive Breast Center of Northwestern Medicine/Prentice Women's Hospital and as they are preparing to leave, a research assistant (RA) will screen potential participants to acquire a randomly selected convenience sample of eligible participants (n=200). The first 100 eligible subjects will be asked if they regularly check their moles for concerning features. If the response is yes, then they will be asked if they have found concerning moles and what they did next. Verbal assent will be obtained.

Then the SSE materials will be placed into the changing rooms and the next 100 eligible subjects will be surveyed. The women, who found the information relevant, will be asked if they chose to check their skin while in the changing room. The skin location checked and use of the SSE kit will be ascertained. Women will be asked if they think they have a concerning mole. If the woman does not find a concerning mole, she will be asked if she intends to check her skin again. In addition, she will be asked if she intends to check the skin of family members. Women will be invited to take a brochure to help implement SSE.

The screening questions are as follows:

  1. During your visit for mammography, did you notice any information about checking your skin for melanoma?

    ___Yes __ No

  2. Did you think this applied to you? ___Yes __ No
  3. If no, why not? (open ended)
  4. If yes, why? (open ended)
  5. Did you check your skin? (If no, please proceed to question #8)

    ___Yes __ No

  6. If yes, did you notice any concerning moles?

    • Yes __ No
  7. If yes, may we contact you by telephone or email in 2 weeks to see if you have made an appointment to see a dermatologist?

    ___Yes __ No If yes, which way do you prefer to be contacted?

    Phone _________________________(Number) Email _________________________ (Address)

  8. If no, will you consider checking your skin in the future?

    ___Yes __ No

  9. If yes, may we contact you by telephone or email in 2 weeks to see if you have checked your skin for any concerning moles?

    ___Yes __ No If yes, which way do you prefer to be contacted?

    Phone _________________________(Number) Email _________________________ (Address)

  10. If you found any concerning moles, did you make an appointment to see a dermatologist.

    • Yes __ No

The RA will record the responses. Women who checked their skin ,either today or in about 2 weeks, will be invited to participate in a survey about skin location(s) checked, use of the SSE kit, and their decision about the spot on the skin.

研究类型

介入性

注册 (实际的)

560

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 Memorial Hospital

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 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

- Qualitative research: structured interview Women 18 years of age and older, who are waiting to have a mammogram Women agree to a structured interview regarding knowledge of melanoma and awareness of melanoma risk.

Following development of a draft of a brochure, women will agree to review a draft and provide comment during a 5 minute interview

  • Qualitative research: focus group Women 18 years of age and older Women with a history of regular mammograms Women with a history of indoor tanning, a personal history of skin cancer, and/or a family history of skin cancer Women willing to participate in a 60 minute focus group to assess materials to be provided during the mammogram experience
  • Quantitative research

Women 18 years of age and older who respond positively to the three screening questions:

Noticed information about checking your skin for melanoma. Thought this information was applicable to them. Checked skin or will consider checking skin in the future.

Exclusion Criteria:

  • Women who are unable to see to read a newspaper, unable to read English, and who have cognitive impairment causing problems with functioning at a sixth grade reading level or inability to speak.

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:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:comparator
As women exit the changing are they will be asked if they regularly check their skin for concerning moles
Prior to placing the intervention materials into the changing rooms, 100 eligible subjects will be asked if they regularly check their moles for concerning features. If the response is yes, then they will be asked if they have found concerning moles and what they did next.
实验性的:Improve awareness of checking moles
Posters, brochures, and skin self-examination kits consisting of a ruler, and a lighted magnifying lens will be placed into each of the 8 changing rooms in the mammogram facility.

Intervention:

  1. Improve awareness Each of the eight changing rooms will have a large mirror that can be used to see the face and chest. Each room will be equipped with a poster, brochures and the SSE kit consisting of the laminated card with a ruler on one edge and the magnifying lens will be fastened to the wall on a cord.
  2. Provide education The subject may chose to read the poster and a brochure. c) A woman research assistant will perform in-person exit interviews with participants to ascertain if women noticed the poster, and found the information relevant.

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
Performance of SSE
大体时间:4 weeks
Checked Moles
4 weeks

次要结果测量

结果测量
措施说明
大体时间
Questionnaire to identify concerning moles
大体时间:2 weeks
Found Concerning mole
2 weeks

其他结果措施

结果测量
措施说明
大体时间
Management of decision
大体时间:2 weeks
Made appointment to see a doctor about the mole
2 weeks

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。

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3月1日

初级完成 (实际的)

2017年7月27日

研究完成 (实际的)

2017年7月27日

研究注册日期

首次提交

2017年2月15日

首先提交符合 QC 标准的

2017年2月15日

首次发布 (实际的)

2017年2月20日

研究记录更新

最后更新发布 (实际的)

2017年10月9日

上次提交的符合 QC 标准的更新

2017年10月6日

最后验证

2017年10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)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

订阅