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Clinical Trials/NCT03057327
NCT03057327
Completed
Not Applicable

Promoting Early Detection of Melanoma During the Mammography Experience

Northwestern University1 site in 1 country560 target enrollmentMarch 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Melanoma (Skin Cancer)
Sponsor
Northwestern University
Enrollment
560
Locations
1
Primary Endpoint
Performance of SSE
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2017
End Date
July 27, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

June Robinson

Research Professor of Dermatology

Northwestern University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Performance of SSE

Time Frame: 4 weeks

Checked Moles

Secondary Outcomes

  • Questionnaire to identify concerning moles(2 weeks)

Study Sites (1)

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