Targeted Melanoma Detection With Skin Self-examination: Leveraging the Mammogram Encounter
Phase: NA
Conditions: Melanoma
Sponsor: Northwestern University

 
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PROTOCOL TITLE: Targeted Melanoma Detection with Skin Self-Examination During 
COVID-19 Restricted Physician Access  
 
PRINCIPAL INVESTIGATOR: 
June K. Robinson, MD 
Northwestern University Feinberg School of Medicine 
Department of Dermatology 
645 N Michigan Ave, Suite 1050 
Chicago, IL 60611 
312-503-5941 
june-robinson@northwestern.edu 
 
 
RESEARCH PERSONNEL: 
Elizabeth L. Grey, MS 
Dalya Abou Durst, BS 
 
STATISTICIAN: 
Mary Kwasny, PhD 
Professor of Preventive Medicine 
Northwestern University Feinberg School of Medicine 
 
 
VERSION DATE:  
April 2, 2020  
 
NCT04420273 
 
 

 
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STUDY SUMMARY: 
The purpose and overarching aim of this study is to reduce melanoma mortality by 
improving early detection of melanoma with skin self-examination among people who 
self-identify as being at risk. Self-management of melanoma detection with skin self-
examination (SSE) depends on ready access to dermatologists when a concerning 
mole is detected. In March 2020, the Illinois stay at home order (COVID-19) removed 
ready physician access and prohibited non-essential health care. Additionally, there was 
uncertainty about when regularly scheduled health care would resume. This submission 
seeks to explore the feasibility of at-home non-invasive mole self-sampling for those 
with a concerning mole with the intention of providing recommendations about the need 
for the mole to be biopsied.  
 
OBJECTIVES: 
Aim 1: To assess the effectiveness of targeted melanoma detection (TMD) with 
SSE education delivered remotely to women who had a screening mammogram. 
The effect of TMD with SSE education on a) SSE performance, b) identification of 
concerning moles, c) time between noticing a concerning mole, requesting a mole self-
sampling kit and receiving health care, and d) SSE sustainability in comparison with 
controls will be assessed among women served by Northwestern Medicine in one rural 
community and one metropolitan community. Health care providers’ (HCPs) 
clinical/pathologic assessment of concerning moles will be identified in the Northwestern 
Medicine electronic health record (EHR) system.  
 
Exploratory Aim: To assess the feasibility of self-sampling concerning moles for 
gene assay. Self-sampling kits will be sent to women who identify concerning moles 
and chose to perform self-sampling rather than watch the mole for change in a month.  
The blinded samples will be sent to DermTech, Inc., a CLIA laboratory, for analysis and 
the results reported directly to the PI. The PI will give the results to the participant, make 
a recommendation about the need to obtain a biopsy of the mole, offer to provide a 
referral to local HCPs, and send the laboratory results to the HCP selected by the 
participant. Anxiety/cancer worry will be assessed monthly to compare a) baseline 
measures, b) initial SSE and c) monitoring concerning moles for change.  
 
Knowledge gained from this study may be helpful to other health care systems serving 
at-risk women and their families in locations with limited access to physicians, especially 
dermatologists.  
 
BACKGROUND: 
Early detection of melanoma remains a crucial component of effective treatment to 
reduce the mortality and morbidity of melanoma and the costs of melanoma care. In the 
United States (US), melanoma incidence has increased by 270% between 1973 and 
2002 and is projected to continue rising in the US with doubling of newly diagnosed 
cases by 2030.1,2 Melanoma is the sixth most common cause of cancer in women in the 
US (fifth in men). There will be an estimated 100,350 new cases and 6,850 deaths in 
2020.11 Melanoma predominantly occurs in non-Hispanic Whites with a history of 
unprotected occupational or recreational sun exposure; however, indoor tanning by 

 
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women as adolescents and young adults contributes to the rising incidence.12,13 People 
with a history of 10 or more indoor tanning sessions in their lifetime,14 a personal or 
family history of melanoma, and a history of sunburn,15,16 are at risk to develop 
melanoma. When people with skin of color, such as Hispanics, develop melanoma they 
are twice as likely to present with late stage disease, thus, fatality is greater.11 
Prognosis is dependent on melanoma stage. For early stage melanoma, the 5-year 
survival is 98%, but for metastatic disease (late stage), the 5-year survival is 25%.17 
Until we effectively address self-management for early detection of melanoma among 
at-risk people, patients will present late in the disease process incurring significant 
mortality, morbidity and health care costs. Early detection of melanoma with SSE, which 
relies on the person promptly presenting for health care, can improve patient 
experience, costs of care, and survival. A case can be made for patient self-
management by informed, confident patients, who appropriately seek health care for 
concerning moles identified with partner assisted SSE.  
 
Since most melanomas are visible on the surface of the skin at a curable phase in their 
evolution, people can perform screening at home with the help of a partner. The annual 
prevalence of self-reported SSE in the general community ranges from 8 to 21%.20 
Women perform more SSE than men.7 Women self-detect more than half of melanomas 
and melanomas detected by women had better prognosis than those detected by men 
because they were identified at an earlier stage.8 The American Academy of 
Dermatology recognized that 6-50% of melanomas were self-detected;21,22 therefore, 
the Academy encourages self-advocacy thorough routine SSE and regular skin cancer 
screening for at-risk patients.23 In a 20 year follow-up case control study of people newly 
diagnosed with melanoma in 1987-89, skin awareness was associated independently 
with a decreased risk of melanoma death (HR=0.46, 95% CI=0.28-0.75, p<0.01).24 
Currently, the median delay in diagnosis, is ~27 months.25 Reports suggest melanomas 
get about 0.12 mm deeper per month with attendant increasing disease stage.26 A 27-
month delay in diagnosis may result in a 0.12 mm deep melanoma (Stage 1A) 
becoming a 3.24 mm melanoma (Stage 2B with greater risk of metastasis). Time to 
presentation for care is a key determinant of the patient outcome. Compared with other 
cancers, melanoma has the longest delays measured as the median time to patient 
presentation. One goal of this research is to reduce the time from a woman first noticing 
a “new or changing mole” to examination by a doctor. 
 
Leveraging the Mammogram Screening Encounter.  
In the US, women age 50 and older develop the habit of having regular screening 
mammograms.27 From 50-59 years of age is also when melanoma incidence in women 
increases.28 In Illinois, screening mammograms may be scheduled without a physician’s 
order, thus, women who do not have regular care with HCPs may obtain mammograms. 
One of the innovations of our proposed study, as described below, is using the 
screening mammography encounter as an opportunity to educate women of all races 
and ethnicities at the point in their lives when melanoma is most likely to develop. In our 
pilot feasibility research, we leveraged mammogram screening encounters to reach 
women, who were not aware of their melanoma risk.4 Women, who are the nexus of 
familial communication of health information and social support in their own homes and 

 
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make 80% of all health care decisions for the family, shared the SSE brochure with 
relatives.4,6,29,30  
 
The long-term goal of this research is to reduce melanoma mortality by improving self-
management of early detection of melanoma. Reduced mortality cannot be proven 
without effective structured melanoma SSE with partner assistance. One way to achieve 
partner-assisted SSE is to deliver a uniform self-management program to women who 
self-identify as at-risk, perform SSE and seek appointments with HCPs for concerning 
moles. In the absence of ready physician access due to COVID-19, we will test the 
feasibility of at-home mole self-sampling with a non-invasive adhesive patch used to 
acquire surface cells of the mole. Our primary objective, assessing effectiveness of a  
SSE education with partner assistance among at-risk women, extends the evidence-
based SSE intervention developed among melanoma survivors and their skin check 
partners (R01CA154908)6 and delivers the program to women who had a screening 
mammogram, which demonstrated the individuals’ commitment to health promotion and 
cancer screening.  
 
STUDY ENDPOINTS: 
Aim 1  
Primary outcome:  
Effectiveness of TMD with SSE will be defined as SSE performance. Further measures 
of fidelity will be assessed by: 
 a) extent of body checked,  
b) recruitment of a skin check partner,  
c) time between noticing a concerning mole, requesting a mole self-sampling kit, and 
seeking HCP care for a concerning mole, and  
d) SSE sustained by monthly performance over 4 months. 
 
Secondary Outcome:  
The effect of TMD with SSE on seeking health care comparing intervention vs control 
groups for: 
a) inappropriate HCP appointments and skin biopsies for benign conditions, and  
b) appropriate HCP appointments for the clinical diagnosis of atypical (dysplastic nevus) 
or rule out melanoma and biopsy performed.  
 
Exploratory Aim  
Proof-of-concept Outcome:  
Research participants will self-sample concerning moles using a kit currently used in 
physician offices to obtain a sample (DermTech, Inc). DermTech, Inc. will perform 
analysis on up to 100 specimens and send the report to the PI. This report will include 
gene assay results or indicate if there are too few cells for analysis, which may reflect 
lack of self-sampling competency. If the initial sample has too few cells for analysis, 
then the instructions will be reviewed by telephone with the participant and an additional 
sample will be obtained. Time to initiation of mole self-sampling after identifying a 
concerning mole, number of kits returned for analysis, and adequate number of cells 
acquired will be assessed. Correlation with monthly SSE anxiety will be done.   

 
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STUDY INTERVENTIONS: 
Contact information for potential subjects, who will be women who had a screening 
mammogram from January 2, 2019 until February 28, 2020, will be obtained from the 
Northwestern Medicine Electronic Data Warehouse (EDW). Based on our experience, 
women with a history of breast cancer will be excluded because the focus of their health 
care is on treatment of breast cancer. Subjects will be emailed a recruitment email 
explaining the research study regarding skin cancer prevention and skin self-
examinations. Subjects will receive a link to the online REDCap program that offers 
electronic consent, randomization, and self-reported surveys. After remotely enrolling in 
the study, and completing the baseline questionnaire, the subjects will be randomized 
1:1 between intervention and control arms. Intervention arm participants will receive the 
SSE brochure. The SSE brochure discusses basic information about melanoma, how to 
identify a melanoma, the importance of a skin check partner, and gives a diary for 
tracking monthly changes in moles via a provided scorecard. The provided postcard 
maybe printed by the woman and affixed to a location in their homes to capture their 
attention and remind participants to perform SSE. Subjects will invite a skin check 
partner to help score the border, color, and diameter of a new and/or concerning 
mole(s) using a provided scoring system for their 4 months of study participation. While 
a skin check partner will be beneficial to perform SSE, a skin check partner is not an 
absolute requirement to participate in this research. The scoring system uses a scale of 
1-3 (1= normal, 2= unsure, 3= not normal). In the brochure, color examples of normal 
and abnormal features illustrate the scoring rules. The decision rules about seeking 
health care are based on the cumulative score of three features of the mole: 3 = benign, 
stop checking the mole; 4-7 = check the mole in one month; 8-9 = make an appointment 
with a doctor to have the mole checked in about 2-3 weeks, which is the standard of 
care for evolving moles. In the absence of physician access (COVD-19), the decision 
rules used in our prior research will be modified to: 
8-9= perform mole self-sampling to determine if the mole needs to be biopsied.         
 
Subjects in the intervention arm will monitor new and concerning moles for 4 months by 
doing monthly skin checks and partner-assisted skin checks (if applicable), record the 
scores on a scorecard provided in their SSE brochure, and complete the monthly online 
survey, which asks about changes in mole scores and potential anxiety associated with 
evolving moles. Subjects will also receive a monthly text message to their personal 
phone with SSE reminders. 
 
If the subject indicates on their monthly survey or by communicating with the study 
team, in the form of an email and/or call, that the score of their mole has increased, 
three options on how to proceed will be offered to the subject. The three choices are as 
follows: a) continue monthly checking the mole for change, b) receive the mole self-
sampling kit to obtain genetic analysis to guide the decision to seek health care, or c) 
seek an appointment with an HCP.  
 
The mole self-sampling kit contains the materials, directions and a Fed Express or 
USPS Express mail envelop to overnight the kit to the DermTech laboratory. 

 
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Participants may request a kit by email or telephone call to the research team, who will 
send the kit by Fed Express or USPS Express mail. Within 3-5 business days, the 
DermTech laboratory will provide the results of the gene analysis online to the PI, Dr. 
Robinson, who will inform the participant with a written report stating: 
a) the mole is benign, and nothing further is needed or  
b) the mole needs to be biopsied.  
 
If the initial sample has too few cells for analysis, then the participant will be invited to 
obtain another sample, instructions will be reviewed by telephone or by Facetime with 
the participant and an additional sample will be obtained. 
 
Participants requiring a skin biopsy will be referred to a local HCP. The research team 
will develop a participant navigation system for triage to a local HCP, including surgical 
oncologists, dermatologists, and family practitioners. This triage system will be used to 
refer participants to schedule an appointment for the skin biopsy within 2-3 weeks. The 
genetic analysis of the mole will be provided in a letter to the HCP selected by the 
participant.  
 
In our prior research, women have checked moles of family members, especially the 
male spouse. We will extend the opportunity for the women enrolled in the study to 
sample the concerning moles of their skin check partner. If throughout the 4 months of 
the intervention arm’s active engagement in skin self-examinations, participants indicate 
that they found a concerning mole on their skin check partner while performing a partner 
skin exam, an opportunity for the mole of the partner to be self-sampled (or sampled by 
the participant) will be offered. For mole self-sampling to occur, the subject would first 
be asked eligibility questions to ensure they are over the age of 18. Once the age is 
established, the partner will be required to sign an electronic consent form, indicating 
what information will be collected and what information will be shared with them and 
their HCP.  
 
Participants who have selected the self-sampling kit will be invited to participate in a 
structured telephone exit interview. The exit interview will seek to obtain feedback from 
the participant on the process of self-sampling and gain feedback on study materials.  
 
PROCEDURES INVOLVED: 
Enrollment to intervention or control arms, randomization, will be automated in REDCap 
using a specific formula generated by the performed Northwestern University’s 
Department of Preventative Medicine statistical team. The randomization of subjects 
who had screening mammograms at Northwestern Medicine Kishwaukee Community 
Hospital Breast Center and Northwestern Medicine Lynn Sage Comprehensive Breast 
Center will continue until about 500 women are enrolled from each location. De-
identified data will be reviewed by the study’s statistical team to ensure there is an equal 
distribution of subjects at each site in both the intervention and control arm.    
 
In the intervention arm (Group 2), the participant will receive the SSE brochure and SSE 
postcard after consenting online and completing baseline assessments. Upon request, 

 
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a printed brochure will be mailed. Participants will receive monthly reminders via email 
and text messaged to their personal phone to perform SSE, to encourage engagement 
and retention. In addition, a monthly REDCap survey will be sent to the subject’s email. 
This monthly survey will include goal setting and reminders to engage a skin check 
partner to help check skin in hard to see areas and to assist with the monitoring of any 
concerning moles and new moles. Tracking of specific details and changes of 
concerning and new moles will be documented on the provided scorecard in the 
brochure. If the score of the mole increases, which is indicated on the monthly survey or 
via email and/or phone, three options on how to proceed with the concerning mole will 
be provided to the subject.  
-Option 1 is to continue monitoring the mole monthly for change.  
-Option 2 will be to perform mole self-sampling with the kit to collect a sample of surface 
cells of the concerning mole with four adhesive patches for gene analysis to help decide 
about seeking further health care for biopsy of the mole. Of note, physician collected 
samples tested for LINC and PRAME gene mutations differentiated melanoma and 
melanoma in situ from benign moles and were confirmed histologically with 91% 
accuracy.  
-Option 3 will be to seek an appointment with a health care provider.  
 
If mole self-sampling is selected, the kit with the subject number as ID (blinded for 
personal identifying information), directions, and postage for the kit to be sent to the 
company that created this self-sampling kit, DermTech, will be provided. Upon 
completing the mole self-sampling and mailing the specimen to the DermTech 
laboratory, it will take 3-5 days for the results to be provided to the PI, Dr. Robinson, in 
the form of a secure online portal. The subject will not obtain their gene test results from 
the DermTech laboratory. Dr. Robinson will provide written test results to the participant 
with the option of discussing the results with a telephone call. A referral will be made to 
the HCP to perform a skin biopsy if needed. The DermTech self-sampling kit is 
approved for use but requires ordering by a licensed HCP, who will be Dr. Robinson, 
the PI.  
 
If the option to see the HCP is selected, the research team will assist with locating one 
and will remind the subject that the HCP may not be available for some time. The study 
team will not cover the cost of seeing the HCP or cost of treatment recommended by 
the HCP. The non-payments details are explicitly stated in the consent document.  
 
If the mole(s) requires a biopsy and/or treatment, the EHR will be reviewed to identify 
diagnosis codes of the mole and review HCP notes.  
 
If throughout the 4 months of active engagement in skin self-examinations, a participant 
in the intervention arm indicates that they found a concerning mole on their skin check 
partner while performing a partner skin exam, an opportunity for the concerning mole of 
the partner to be self-sampled will be offered. For the self-sampling to occur, the subject 
(the skin check partner) would first be asked eligibility questions to ensure they are over 
the age of 18 and meet basic eligibility criteria. Once eligibility is established, the partner 
will be sent an electronic consent form, via REDCap, and complete and sign the form, 

 
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indicating they understand what is expected of them as a research participant and the 
information that was presented to them in the consent document. The same process will 
be followed for the skin check partner as is in place for the research subject.  
 
Controls (Group 1) will receive a healthy lifestyle brochure and a healthy lifestyle 
postcard after consenting online and completing baseline assessments. After enrolling 
in the study, a baseline survey will populate in REDCap, and the subject will be able to 
download a healthy lifestyle brochure and the postcard reminder. Upon request, the 
brochure will be mailed. Each month, the subject will receive an email to complete the 
monthly survey and will receive healthy lifestyle text messages to their mobile phone. 
The survey they receive will mirror the survey of the SSE intervention arm; therefore, 
awareness of SSE will be expected to increase, and SSE may be initiated among 
controls. If a subject indicates that they have found a concerning mole on their monthly 
survey, the subject will be advised to reach out to their health care provider for further 
assessment. After completing the final monthly survey, controls will be offered the SSE 
brochure.  
 
Intervention participants who have selected the mole self-sampling kit will be invited to 
participate in a structured telephone exit interview. The exit interview will seek to obtain 
feedback from the participant on the process of mole self-sampling and gain feedback 
on study materials. Subjects will be asked, at time of consent, if the study team has 
permission to audio record the exit interview for purposes of data analysis. Subjects 
may opt out of the audio-recording portion of the study. The researcher will not share 
these recordings with anyone outside of the immediate study team. The recordings will 
remain in locked file cabinets and on computers with restricted and password protected 
access. 
 
Anxiety will be assessed on monthly surveys. If enhanced anxiety regarding a 
concerning mole is indicated, a referral for psychological support will be made my PI, 
Dr. June Robinson.  
 
Out of the 500 women enrolled at each location, it is expected that 140 of the 1000 
(14%) enrolled will identify a concerning mole.4  
 
DATA AND SPECIMEN BANKING: 
See Data Management. Specimens will not be banked.  
 
SHARING RESULTS WITH PARTICIPANTS: 
Results of the gene analysis from the cells captured by the adhesive patches will be 
provided to the PI, Dr. June Robinson. Dr. Robinson will then inform the participant, in 
the form of a written report, if the mole is benign and nothing further needs to be done 
or if the mole needs to be biopsied. If requested, Dr. Robinson will discuss the report 
with participants. Participants requiring a skin biopsy will be referred to a local HCP, 
who will receive the genetic analysis of the mole via fax from Dr. Robinson. At the 
conclusion of the study, all participants will receive an email summary of the results. 

 
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The same process of sharing results applies to participants and their skin check 
partners who have a concerning mole to self-sample.   
 
 
STUDY TIMELINES:  
Subjects, both intervention and controls will be engaged with the research for 4 months. 
After 4 months of active engagement, follow-up communication will only occur via 
telephone or email to answer any incomplete questions on surveys or any questions 
that arise from evaluating the EHR of HCP visits regarding the concerning mole(s). All 
communication will be documented in the subject’s file as a progress note. 
 
In order to complete this research before the end of the grant (March 2021), we need to 
have IRB approval in early May, which will allow EDW to build the lists of eligible 
subjects. Then we will enroll subjects remotely in June-August 2020 and follow them for 
4 months with online surveys (Oct-Dec 2020). Finally, the EHR of HCP visits will be 
reviewed about 3-4 months after the completion of the last online survey. This additional 
period of EHR review (Feb 2021- March 2021) gives subjects time to obtain an 
appointment with their HCP and have a biopsy, if needed. 
 
 
INCLUSION AND EXCLUSION CRITERIA: 
Inclusion Criteria:  
- Adult women (aged 18 and older) having a screening mammogram with no upper 
age limit, who had a screening mammogram from January 1, 2019 to February 
28, 2020. 
- Able to read English 
- Vision enough to read a newspaper 
-  Self-perception of their potential melanoma risk 
- Willing to perform SSE with a skin check partner 
- Willing to complete monthly surveys for 4 months and receive monthly text 
messages to personal mobile phone 
- Have home Internet access and smartphone with data plan 
- Have access to Federal Express or US Postal Service Express Mail to send mole 
self-sampling kits  
- Willing to allow the research team access to their electronic health record to 
abstract physician assessment of concerning moles, biopsy results and treatment 
- Willing to provide up-to-date email address, mailing address and telephone 
number 
 
Inclusion criteria of skin check partner to have mole self-sampled 
- Male or female over the age of 18 years 
- Able to read English 
- Vision enough to read a newspaper 
 
Exclusion criteria 
- Women under the age of 18 years 

 
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- Women overburdened with other co-morbid diseases, medical treatments (e.g., 
chemotherapy), or cognitive impairment (e.g., by a stroke) as determined by the 
PI. 
- Previous participation in SSE research previously which may be a confounding 
variable in data analysis  
 
Exclusion criteria of skin check partner to have mole self-sampled 
- Male or female under the age of 18 
- Unable to read English 
 
VULNERABLE POPULATIONS: 
This study will not include the participation of vulnerable populations 
 
 
PARTICIPANT POPULATIONS: 
Accrual 
Number: 
Category/ 
Group: 
 
Consented: 
Maximum Number 
to be Consented or 
Reviewed/Collected
/Screened 
Enrolled: 
Number to 
Complete the Study 
or Needed to 
Address the 
Research Question 
Northwestern 
Medicine: 
Prentice 
Women’s 
Breast Center 
Women ≥ 18 
years old 
500 
400 
Northwestern 
Medicine: 
Kishwaukee 
Breast Center 
Women ≥ 18 
years old 
500 
400 
Total: 
 
1000 
800 
 
 
RECRUITMENT METHODS: 
Recruitment for this study will use the Northwestern Medicine Electronic Data 
Warehouse (EDW) to obtain contact information of women, over the age of 18, who 
have had a screening mammogram. 
 
Women, who completed their screening mammogram, will be sent a general recruitment 
email using the secure data collection method, REDCap. This email will allow women to 
click on a link that generates an interest email. If interested, an eligibility questionnaire 
will populate using REDCap branching logic. If a woman is eligible, based on the 
inclusion criteria, the consent form will populate.  If no response to the email is received, 
a second email will be sent in 5 days. If participants do not respond to the initial and 
follow-up email, we will follow-up by phone.  
 

 
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COMPENSATION FOR PARTICIPATION IN RESEARCH ACTIVITIES: 
Research subjects will be compensated with a $20 Amazon electronic gift card for 
completing the baseline survey and a $15 Amazon electronic gift card for each 
completed monthly survey for 4 months ($80 paid after completing the final survey). The 
total amount a research subject can receive for participation in this research study is 
$100 in the form of Amazon electronic gift cards. 
 
RISKS TO PARTICIPANTS: 
The potential risks to participants are expected to be minimal if they occur.  
 
Subjects will be participating in an intervention that may enhance their awareness of 
their risk of developing skin cancer. All study participants will be provided with an email 
address and phone number to contact study staff in the event they have concerns. If a 
subject indicates they have a concerning mole, they will be provided with three options 
on how to address the mole. The research team will be in communication with the 
subject to ensure there are no questions or concerns regarding next steps. Because of 
the potential for the intervention to help the subject identify melanoma at a stage of 
development with the best prognosis, we feel that the potential benefits, in reduced 
morbidity and mortality, to the subject outweigh the risk of potential enhanced anxiety in 
discovering a suspicious mole. If subjects report high levels of anxiety, then a referral 
for psychological support would be made. We do not believe that subjects in this study 
will be exposed to any risk of physical or psychological harm as a result of either the 
intervention or research processes. Our measures do not assess individuals at risk of 
immediately harming themselves (e.g. suicide); therefore, we will not have to screen the 
data to potentially intervene with individuals who may be a risk to themselves.  
 
POTENTIAL BENEFITS TO PARTICIPANTS: 
Because of the potential for the intervention to help the subject improve their ability to 
detect melanomas in the early and potentially curable phase, they will reduce their risk 
of death from melanoma. We feel that the potential benefits in reduced morbidity and 
mortality to the subject outweigh the risk of potential enhanced anxiety in discovering 
that they are at risk to develop another melanoma. If subjects report high levels of 
anxiety, then a referral for psychological support would be made.  
 
DATA MANAGEMENT AND CONFIDENTIALITY: 
Data Management and Quality Control 
Data will be collected via REDCap and by EHR data abstraction to populate the 
database. The subject number identifies the specimen on the case report form for gene 
sampling of moles. All databases are encrypted and stored on study specific servers at 
Northwestern University. Forms and database architecture will be set up during study 
preparation and launch. Only authorized study personnel can access these servers. Our 
data manager maintains data integrity and does fidelity checks and performs regular 
data checking for accuracy and completeness in coordination with the PI. 
 
Design, Analysis, and Power Calculation with Target Enrollment Justification 

 
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For the RCT, participants will be randomly assigned to receive the SSE intervention or 
control (healthy lifestyle) in a 1:1 ratio. This will result in approximately 500 participants 
in each group. The primary analysis will be intent to treat, with data imputed one of two 
ways. First, we will run a “worse-case scenario” where all drop- outs will be assumed to 
not be performing SSE. Second, we will create 5 imputed data sets for missing data 
based on all available data and analyze with PROC MIANALYZE to obtain valid 
statistical inferences. From previous work, we expect at least 60% retention at 4 
months. 
 
We will use GLMM with a logit link to test if the intervention affects the rate of SSE, 
while adjusting for the repeated measures within individuals over the first 4 months. 
Using these repeated measures, and assuming an autocorrelation of 0.9, a total sample 
of 1000 would enable us to detect an increase from 80% of SSE in the control group to 
86.3% in the intervention group. Assuming only 10% discordance, a sample of 500 
control women provides 80% power to detect an increase of 7%, while the remaining 
3% cease SSE. Additional fidelity measures in Aim 2 will be combined to score an 
overall standardized fidelity score at each time. If the mean fidelity score is 80%, a 
sample of 500 women provide enough information to produce a 95% Confidence 
interval with a width of 0.09. The sample for 500 intervention women provides 80% 
power to detect declining fidelity or sustainability of monthly SSEs as a standardized 
slope of 0.13. The secondary outcome of seeking HCP appointments for a necessary 
mole will be analyzed with generalized linear models, as described above, but 
considering the outcome as “any HCP appointment” during the study time frame. 
Previous data suggests that approximately 14% of women should contact HCP for an 
appointment, and our sample of 1000 women provides 80% power to detect a baseline 
rate in the control group as small as 21%. 
 
Plans for securing the data is in the “provisions to protect the privacy interests of 
participants” section of the protocol.  
 
PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF 
PARTICIPANTS: 
All subjects are encouraged and will be encouraged throughout the course of their 
participation in the research study to contact the PI, Dr. Robinson at Northwestern, to 
report complaints or adverse events. A telephone number and email address will be 
provided to subjects to contact Dr. Robinson if they have any concerns or increased 
anxiety, or if they become worried about developing skin cancer. Instructions for 
reporting adverse events and complaints are included in the consent documents and on 
all contact, information provided to subjects through the course of the study. Any 
significant adverse events will be reported to NIH in addition to the local IRB, in 
compliance with federal regulations. Our measures do not assess individuals at risk of 
immediately harming themselves (e.g., suicide); therefore, we will not have to screen 
the data to potentially intervene with individuals who may be a risk to themselves. Dr. 
Robinson has been a board-certified physician for over three decades and has 
conducted an NCI funded R01 of a similar nature. We will notify the Northwestern 
University IRB, our project officers, and NCI within 24-48 hours of any serious adverse 

 
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event. We will provide an annual report to the NCI Project Officer summarizing all 
adverse events, should any arise. 
 
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS: 
This research includes provisions for protecting the privacy of research subjects. Study 
interactions will take place in person, through electronic collection data forms using 
REDCap, with a paper-based on the case report form for gene sampling of moles that 
used a subject number to identify the specimen, and by telephone. The research team 
will make every effort to address the questions and concerns of potential and current 
subjects. Steps will be taken to ensure that the subjects feel at ease throughout the 
entire process. To reduce the sense of intrusiveness a subject may experience in 
response to survey questions, subjects will be informed that they may decline to provide 
any information they do not wish to disclose. The information being collected is limited 
to only the minimum amount of data necessary to accomplish the research purposes. 
 
The research team will be permitted to access study-related, subject-reported 
information and the EHR of subjects who have a visit with a health care provider for a 
concerning mole. The EHR of skin check partners will not be accessed. The database 
that will house this data will only have de-identified data. A unique subject number will 
replace the use of names in the database. Our systems are guarded against outside 
entry by Northwestern’s own firewall supporting 128-bit encryption. This level of 
encryption provides the highest level of protection against hackers, computer break-ins, 
etc. All data is de-identified. Only experienced research team members will work on this 
study and will have receive training that includes an emphasis upon the importance of 
confidentiality of information, and all personnel on the project will complete the required 
NIH training in the protection of human research participants. Physical copies of 
collected data forms will be retained in separate locked file cabinets and on computers 
with restricted and password-protected access, without links to the master code list. All 
data based on the research will be reported in aggregate form. No individual 
respondents will be identified. Electronic data will be maintained in a study-specific 
database on the server of the Department of Dermatology at the Feinberg School of 
Medicine. Paper-based files will be kept in a locked cabinet in a locked room within the 
Northwestern University Department of Dermatology research offices. Identifiable data 
will be kept separate from the case report forms and source documents. Data gathered 
as a result of this study are available to inspection on request by the Food and Drug 
Administration or other government regulatory agency auditors, and the Northwestern 
University Institutional Review Board (IRB). 
  
Only approved research personnel will have access to the stored data. The PI is 
ultimately responsible for the receipt and transmission of the data. As per the 
Department of Dermatology protocol, data will be retained indefinitely after the 
completion of the study. All data and other information in this study will be maintained 
confidentially.  
 
ECONOMIC BURDEN TO PARTICIPANTS: 

 
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Taking part in this research study will not lead to any costs for subjects unless the 
option of seeing an HCP for a new or concerning mole is selecting. This research will 
not cover the cost of a copayment for seeing the HCP or any cost of treatment or care 
provided by the HCP.  No monetary or non-monetary (gift cards, coupon codes) forms 
of reimbursement options will be provided to subjects for health care resulting from 
finding a concerning mole. This information is explicitly stated in the consent document. 
 
CONSENT PROCESS: 
Participants will be required to answer eligibility questions prior to obtaining access to 
the online consent form (REDCap). A question on the eligibility criteria will ask 
participants if they feel comfortable reading and completing the consent process 
electronically. Question regarding the research will be invited and answered by 
telephone as needed. If a participant indicates she would like to participate in the 
research study, the consent document will be completed electronically and the 
participant will complete the following survey items electronically, as they will be sent to 
the participant’s email.  
 
The electronic consent process will use the secure data collection platform, REDCap. 
Participants will have questions asking them if they would like to speak to a research 
team member before signing the consent form. Questions will also be in place to ensure 
that the subject is comfortable with what is required of them if they agree to participate 
in the research and that they understand the information. If they indicate no to either of 
the questions, the consent form will generate an option for a phone number to be 
collected for a study team member to contact the potential subject to review the 
information. These steps are put in place to ensure each subject is comfortable with the 
information in the consent form, before being enrolled in the study. 
 
 
PROTECTED HEALTH INFORMATION: 
This research study involves the use of Protected Health Information. A HIPAA 
Authorization will be obtained from all subjects. This Authorization will be included in the 
consent document. Subjects who do not authorize the use of their PHI will have the 
alternative of not participating in this study. Information to be obtained from EDW by 
access to EHR data  is indicated below: 
- Name 
­ Geographic Subdivisions 
­ Dates and Age 
- Telephone numbers 
- Email address 
- Medical Record Numbers 
- Most recent mammography screening appointment information (date of 
screening mammogram and location of screening mammogram) 
The EHR will be reviewed by the PI for: 
- Health care provider notes from visit pertaining to a concerning mole (date of 
visit, notes from visit, diagnosis code of mole, plan of treatment and/or treatment) 
 

 
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HIPAA Authorization will not be obtained from skin check partners, as the study team 
will not be viewing their EHR. 
 
QUALIFICATIONS TO CONDUCT RESEARCH AND RESOURCES AVAILABLE: 
Dr. Robinson has been a board-certified physician for over three decades and has 
conducted an NCI funded R01 and R21 of a similar nature. We will notify the 
Northwestern University IRB, our project officers, and NCI within 24-48 hours of any 
serious adverse event. All research assistants have CITI documents on file. Other 
resources. Lynn Sage Breast Center completes approximately 90,000 screening 
mammograms each year and Kishwaukee Hospital completes approximately 7,000 
screening mammograms/year; therefore, there are adequate numbers of potential 
subjects to be identified by the EDW search. Dr. Robinson has full-time research staff 
and voluntary medical students who fully support this research study at 100% effort. Dr. 
Robinson also has weekly meetings with research staff to address any questions 
regarding the protocol, questions from research subjects, or study related procedures.  
 
MULTI-SITE RESEARCH: 
NA 
 
 
 
 
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