Promoting Early Detection of Melanoma During the Mammography Experience

NCT03057327 | Completed

• 1 other identifier: STU00204685
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma (Skin Cancer)

Outcome Measures

Primary Outcomes (1)

• Performance of SSE

  Checked Moles

  4 weeks

Secondary Outcomes (1)

• Questionnaire to identify concerning moles

  2 weeks

Other Outcomes (1)

• Management of decision

  2 weeks

Study Arms (2)

comparator

ACTIVE COMPARATOR

As women exit the changing are they will be asked if they regularly check their skin for concerning moles

Other: Comparator

Improve awareness of checking moles

EXPERIMENTAL

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

Interventions

Improve awareness of checking moles BEHAVIORAL

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.

Improve awareness of checking moles

Comparator OTHER

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.

comparator

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor of Dermatology

Model Details: sequential single group

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 20, 2017
• Study Start: March 1, 2017
• Primary Completion: July 27, 2017
• Study Completion: July 27, 2017
• Last Updated: October 9, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)