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Promoting Early Detection of Melanoma During the Mammography Experience

Primary Purpose

Melanoma (Skin Cancer)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Improve awareness of checking moles
Comparator
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Melanoma (Skin Cancer)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Northwestern Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

comparator

Improve awareness of checking moles

Arm Description

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

Outcomes

Primary Outcome Measures

Performance of SSE
Checked Moles

Secondary Outcome Measures

Questionnaire to identify concerning moles
Found Concerning mole

Full Information

First Posted
February 15, 2017
Last Updated
October 6, 2017
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT03057327
Brief Title
Promoting Early Detection of Melanoma During the Mammography Experience
Official Title
Promoting Early Detection of Melanoma During the Mammography Experience
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
July 27, 2017 (Actual)
Study Completion Date
July 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: During your visit for mammography, did you notice any information about checking your skin for melanoma? ___Yes __ No Did you think this applied to you? ___Yes __ No If no, why not? (open ended) If yes, why? (open ended) Did you check your skin? (If no, please proceed to question #8) ___Yes __ No If yes, did you notice any concerning moles? Yes __ No 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) If no, will you consider checking your skin in the future? ___Yes __ No 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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin Cancer)

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
sequential single group
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
560 (Actual)

8. Arms, Groups, and Interventions

Arm Title
comparator
Arm Type
Active Comparator
Arm Description
As women exit the changing are they will be asked if they regularly check their skin for concerning moles
Arm Title
Improve awareness of checking moles
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Improve awareness of checking moles
Intervention Description
Intervention: 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. 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.
Intervention Type
Other
Intervention Name(s)
Comparator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Performance of SSE
Description
Checked Moles
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Questionnaire to identify concerning moles
Description
Found Concerning mole
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
Management of decision
Description
Made appointment to see a doctor about the mole
Time Frame
2 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Promoting Early Detection of Melanoma During the Mammography Experience

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