Promoting Early Detection of Melanoma During the Mammography Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 560
- 试验地点
- 2
- 主要终点
- Performance of SSE
研究概览
简要总结
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.
详细描述
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:
- 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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
comparator
As women exit the changing are they will be asked if they regularly check their skin for concerning moles
干预措施: Comparator (Other)
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.
干预措施: Improve awareness of checking moles (Behavioral)
结局指标
主要结局
Performance of SSE
时间窗: 4 weeks
Checked Moles
次要结局
- Questionnaire to identify concerning moles(2 weeks)
研究者
June Robinson
Research Professor of Dermatology
Northwestern University