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Promoting Early Detection of Melanoma During the Mammography Experience

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03057327
Recruitment Status : Completed
First Posted : February 20, 2017
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
June Robinson, Northwestern University

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.


Condition or disease Intervention/treatment Phase
Melanoma (Skin Cancer) Behavioral: Improve awareness of checking moles Other: Comparator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 560 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: sequential single group
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Promoting Early Detection of Melanoma During the Mammography Experience
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : July 27, 2017
Actual Study Completion Date : July 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arm Intervention/treatment
Active Comparator: comparator
As women exit the changing are they will be asked if they regularly check their skin for concerning moles
Other: Comparator
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.

Experimental: 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.
Behavioral: Improve awareness of checking moles

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.




Primary Outcome Measures :
  1. Performance of SSE [ Time Frame: 4 weeks ]
    Checked Moles


Secondary Outcome Measures :
  1. Questionnaire to identify concerning moles [ Time Frame: 2 weeks ]
    Found Concerning mole


Other Outcome Measures:
  1. Management of decision [ Time Frame: 2 weeks ]
    Made appointment to see a doctor about the mole



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057327


Locations
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United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
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Responsible Party: June Robinson, Research Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT03057327    
Other Study ID Numbers: STU00204685
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases