Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-02-20 @ 4:36 PM
Study NCT ID:
NCT03057327
Status:
COMPLETED
Last Update Posted:
2017-10-09
First Post:
2017-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promoting Early Detection of Melanoma During the Mammography Experience
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
Promoting Early Detection of Melanoma During the Mammography Experience
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: