Clinical trial NCT03057327: Promoting Early Detection of Melanoma During the Mammography Experience
Official title: Promoting Early Detection of Melanoma During the Mammography Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma (Skin Cancer)
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2017-02-20
Enrollment: 560
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: sequential single group
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Performance of SSE
timeFrame: 4 weeks
Secondary outcomes:
measure: Questionnaire to identify concerning moles
timeFrame: 2 weeks
Other outcomes:
measure: Management of decision
timeFrame: 2 weeks
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
References: