Melanoma
Conditions
Brief summary
The purpose of this study is to reduce melanoma mortality by improving early detection of melanoma with skin self-examination (SSE) among people who self-identify as being at risk and seek care for a concerning mole. Because women are more likely than men to perform SSE, women who are engaged in health promotion by having a recent screening mammogram are the focus of this research. Self-management of melanoma detection with SSE depends on ready access to dermatologists when a concerning mole is detected. In March 2020, the Illinois stay at home order (COVID-19) prohibited non-essential health care, including screening mammography and dermatology office-based care, and both are expected to remain limited until fall 2020. This submission explores a) the effectiveness of targeted melanoma detection (TMD) among women, who identify their risk of having a melanoma, learn to perform SSE, and perform SSE, and b) the effectiveness of adhesive patch-based home sample collection for genomic analysis to rule out melanoma in moles identified by women (who received the intervention) as concerning will be explored.
Detailed description
The proposed work will 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 will be assessed with a randomized control trial among women served by Northwestern Medicine in rural, suburban and metropolitan communities. Women who identify concerning moles will choose among three options: a) watch the mole to see if the border, color or diameter of the mole changes b) send a picture of the mole to the PI for consideration of mole self-sampling, or c) make an appointment with my healthcare provider to check the mole. As required a physician will supervise women, who will perform non-invasive mole self-sampling with non-invasive adhesive patches for genomic analysis of the concerning pigmented lesion (mole). If the genomic analysis suggests that the concerning mole may be a melanoma, then the recommendation will be to have the mole biopsied.The effectiveness of acquired samples suggestive of melanoma will be examined by the obtaining the pathology reports of biopsied moles. Health care providers' (HCPs) clinical/pathologic assessment of concerning moles will be identified in the Northwestern Medicine electronic health record (EHR) system.
Interventions
BEHAVIORALSSE educational intervention
Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
BEHAVIORALActive control:Healthy Living
Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized Control Clinical Trial Arm 1: SSE educational intervention with optional physician supervised non-invasive adhesive patch-based home sample collection of a concerning mole for genomic analysis Arm 2: Active control
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult women (aged 18 and older) 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 either alone or with a skin check partner * Willing to complete monthly surveys for 3 months and receive monthly text messages to personal mobile phone * Have home Internet access and phone with ability to take a picture of a mole * 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, who may be a man or a woman, 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
* Male * Female under the age of 18 * Unable to read English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Completed SSE at Specified Time Points | 90 days | Self-reported performance of SSE, a custom scale with the frequency and extent of SSE is completed in an online monthly survey |
| Number of Participants Who Identified Concerning Moles at Specified Time Points | 90 days | Self-reported identification of concerning mole identified by user assigning scores to the border,color and diameter of the mole. A validated scoring system is used to categorize the border, color and diameter as 1 if normal, 2 if not sure, and 3 if abnormal.The sum of the scores indicates if the mole is concerning (sum of 3= benign, stop checking the mole; sum of 4- 7 monitor the mole for change in the next month; sum of 8-9 = concerning mole make an appointment to see a physician. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Diagnosis of Participants Having Any Physician Visits for Concerning Moles | 5 months | Electronic medical record review of physician's clinical diagnosis of concerning mole during the 3 months of the study and for 2 subsequent months |
| Participants' Reported Skin Self-examination Anxiety | 90 days | Self-reported responses to 6 items, each with a 5-point Likert scale (range 6-30) higher score= more anxiety, a worse outcome |
| Biopsy Performed | 5 months | EMR review of physician performing a biopsy on a concerning mole identified by the participant, percentage of biopsies performed |
| Pathologic Diagnosis of Concerning Moles | 5 months | Electronic medical record review of pathologic diagnosis of biopsied moles that participants identified as concerning |
| Participants' Confidence Performing Mole Checks | 90 days | Self-reported responses to 7 items, each with a 5-point Likert scale (range 7-35) higher score = greater confidence (better outcome). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SSE Educational Intervention Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE. | 494 |
| Active Control: Healthy Living Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living. | 495 |
| Total | 989 |
Baseline characteristics
| Characteristic | SSE Educational Intervention | Active Control: Healthy Living | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 494 Participants | 495 Participants | 989 Participants |
| Age, Continuous | 47.0 years | 47.0 years | 47.0 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 37 Participants | 36 Participants | 73 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 457 Participants | 459 Participants | 916 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) White | 485 Participants | 480 Participants | 965 Participants |
| Sex: Female, Male Female | 494 Participants | 495 Participants | 989 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| skin type I (always sunburn, never tan) | 29 Participants | 22 Participants | 51 Participants |
| skin type III (sometimes sunburn, tan moderately) | 216 Participants | 200 Participants | 416 Participants |
| skin type II (usually sunburn, tan minimally) | 213 Participants | 230 Participants | 443 Participants |
| skin type IV(rarely sunburn, tan deeply) | 36 Participants | 43 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 494 | 0 / 495 |
| other Total, other adverse events | 0 / 494 | 0 / 495 |
| serious Total, serious adverse events | 0 / 494 | 0 / 495 |
Outcome results
Primary
Number of Participants Who Completed SSE at Specified Time Points
Self-reported performance of SSE, a custom scale with the frequency and extent of SSE is completed in an online monthly survey
Time frame: 90 days
Population: Home sample collection arm participants were randomized into arm 1 at baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SSE Educational Intervention | Number of Participants Who Completed SSE at Specified Time Points | baseline ever perform SSE | 217 Participants |
| SSE Educational Intervention | Number of Participants Who Completed SSE at Specified Time Points | 1-mo perform SSE | 475 Participants |
| SSE Educational Intervention | Number of Participants Who Completed SSE at Specified Time Points | 2-mo perform SSE | 355 Participants |
| SSE Educational Intervention | Number of Participants Who Completed SSE at Specified Time Points | 3-mo perform SSE | 348 Participants |
| Active Control: Healthy Living | Number of Participants Who Completed SSE at Specified Time Points | 3-mo perform SSE | 211 Participants |
| Active Control: Healthy Living | Number of Participants Who Completed SSE at Specified Time Points | baseline ever perform SSE | 242 Participants |
| Active Control: Healthy Living | Number of Participants Who Completed SSE at Specified Time Points | 2-mo perform SSE | 228 Participants |
| Active Control: Healthy Living | Number of Participants Who Completed SSE at Specified Time Points | 1-mo perform SSE | 238 Participants |
Comparison: 1-month surveyp-value: <0.001McNemar
Comparison: 2- monthsp-value: <0.001McNemar
Comparison: 3-monthsp-value: <0.001McNemar
Primary
Number of Participants Who Identified Concerning Moles at Specified Time Points
Self-reported identification of concerning mole identified by user assigning scores to the border,color and diameter of the mole. A validated scoring system is used to categorize the border, color and diameter as 1 if normal, 2 if not sure, and 3 if abnormal.The sum of the scores indicates if the mole is concerning (sum of 3= benign, stop checking the mole; sum of 4- 7 monitor the mole for change in the next month; sum of 8-9 = concerning mole make an appointment to see a physician.
Time frame: 90 days
Population: While 494 participants were randomized to receive the intervention, only 278 participants found a concerning mole. Similarly 495 participants were randomized to the active control arm, but only 144 identified a concerning mole. Thus the number analyzed in each arm is limited to the number of participants identifying a concerning mole.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SSE Educational Intervention | Number of Participants Who Identified Concerning Moles at Specified Time Points | Made physician appointment | 39 Participants |
| SSE Educational Intervention | Number of Participants Who Identified Concerning Moles at Specified Time Points | Followed mole for change | 239 Participants |
| SSE Educational Intervention | Number of Participants Who Identified Concerning Moles at Specified Time Points | stopped SSE | 0 Participants |
| Active Control: Healthy Living | Number of Participants Who Identified Concerning Moles at Specified Time Points | Made physician appointment | 107 Participants |
| Active Control: Healthy Living | Number of Participants Who Identified Concerning Moles at Specified Time Points | Followed mole for change | 7 Participants |
| Active Control: Healthy Living | Number of Participants Who Identified Concerning Moles at Specified Time Points | stopped SSE | 30 Participants |
p-value: <0.001Chi-squared
Secondary
Biopsy Performed
EMR review of physician performing a biopsy on a concerning mole identified by the participant, percentage of biopsies performed
Time frame: 5 months
Population: percentage of participants having a biopsy of a concerning mole
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SSE Educational Intervention | Biopsy Performed | 56.4 percentage of participants having a biop |
| Active Control: Healthy Living | Biopsy Performed | 13.1 percentage of participants having a biop |
p-value: <0.001Chi-squared
Secondary
Clinical Diagnosis of Participants Having Any Physician Visits for Concerning Moles
Electronic medical record review of physician's clinical diagnosis of concerning mole during the 3 months of the study and for 2 subsequent months
Time frame: 5 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSE Educational Intervention | Clinical Diagnosis of Participants Having Any Physician Visits for Concerning Moles | Clinical diagnosis benign | 14 participants |
| SSE Educational Intervention | Clinical Diagnosis of Participants Having Any Physician Visits for Concerning Moles | Clinical diagnosis atypical nevus | 15 participants |
| SSE Educational Intervention | Clinical Diagnosis of Participants Having Any Physician Visits for Concerning Moles | Clinical diagnosis melanoma | 10 participants |
| Active Control: Healthy Living | Clinical Diagnosis of Participants Having Any Physician Visits for Concerning Moles | Clinical diagnosis benign | 93 participants |
| Active Control: Healthy Living | Clinical Diagnosis of Participants Having Any Physician Visits for Concerning Moles | Clinical diagnosis atypical nevus | 9 participants |
| Active Control: Healthy Living | Clinical Diagnosis of Participants Having Any Physician Visits for Concerning Moles | Clinical diagnosis melanoma | 5 participants |
p-value: <0.001Chi-squared
Secondary
Participants' Confidence Performing Mole Checks
Self-reported responses to 7 items, each with a 5-point Likert scale (range 7-35) higher score = greater confidence (better outcome).
Time frame: 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SSE Educational Intervention | Participants' Confidence Performing Mole Checks | Baseline | 9.3 units on a scale | Standard Deviation 0.05 |
| SSE Educational Intervention | Participants' Confidence Performing Mole Checks | Follow-up-3 month | 11.6 units on a scale | Standard Deviation 0.05 |
| Active Control: Healthy Living | Participants' Confidence Performing Mole Checks | Baseline | 9.3 units on a scale | Standard Deviation 0.05 |
| Active Control: Healthy Living | Participants' Confidence Performing Mole Checks | Follow-up-3 month | 10.0 units on a scale | Standard Deviation 0.05 |
p-value: <0.001Chi-squared
Secondary
Participants' Reported Skin Self-examination Anxiety
Self-reported responses to 6 items, each with a 5-point Likert scale (range 6-30) higher score= more anxiety, a worse outcome
Time frame: 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SSE Educational Intervention | Participants' Reported Skin Self-examination Anxiety | Baseline | 6.4 units on a scale | Standard Deviation 0.05 |
| SSE Educational Intervention | Participants' Reported Skin Self-examination Anxiety | Follow-up month 3 | 6.6 units on a scale | Standard Deviation 0.05 |
| Active Control: Healthy Living | Participants' Reported Skin Self-examination Anxiety | Baseline | 6.4 units on a scale | Standard Deviation 0.05 |
| Active Control: Healthy Living | Participants' Reported Skin Self-examination Anxiety | Follow-up month 3 | 6.6 units on a scale | Standard Deviation 0.05 |
p-value: <0.1Chi-squared
Secondary
Pathologic Diagnosis of Concerning Moles
Electronic medical record review of pathologic diagnosis of biopsied moles that participants identified as concerning
Time frame: 5 months
Population: all participants in arm 3 had benign moles on the home sample collected
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSE Educational Intervention | Pathologic Diagnosis of Concerning Moles | melanoma stage 1A | 4 participants |
| SSE Educational Intervention | Pathologic Diagnosis of Concerning Moles | benign nevus | 0 participants |
| SSE Educational Intervention | Pathologic Diagnosis of Concerning Moles | melanoma stage 0 | 5 participants |
| SSE Educational Intervention | Pathologic Diagnosis of Concerning Moles | atypical nevus | 13 participants |
| SSE Educational Intervention | Pathologic Diagnosis of Concerning Moles | melanoma stage 1B | 0 participants |
| Active Control: Healthy Living | Pathologic Diagnosis of Concerning Moles | atypical nevus | 6 participants |
| Active Control: Healthy Living | Pathologic Diagnosis of Concerning Moles | melanoma stage 1B | 1 participants |
| Active Control: Healthy Living | Pathologic Diagnosis of Concerning Moles | melanoma stage 0 | 3 participants |
| Active Control: Healthy Living | Pathologic Diagnosis of Concerning Moles | benign nevus | 1 participants |
| Active Control: Healthy Living | Pathologic Diagnosis of Concerning Moles | melanoma stage 1A | 3 participants |
p-value: 0.459Chi-squared
p-value: <0.001Chi-squared