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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSE educational intervention | Experimental | Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE. |
|
| Active control: Healthy Living | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSE educational intervention | Behavioral | Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 90 days |
| 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. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 90 days |
| Participants' Confidence Performing Mole Checks |
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Inclusion Criteria:
Inclusion criteria of skin check partner, who may be a man or a woman, to have mole self-sampled
Exclusion Criteria:
Self-representation as a woman
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| Name | Affiliation | Role |
|---|---|---|
| June K Robinson, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine Department of Dermatology | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30773613 | Background | Robinson JK, Reavy R, Mallett KA, Turrisi R. Remote partner assisted skin self-examination skills training of melanoma survivors and their partners. Australas J Dermatol. 2019 Feb;60(1):e80-e82. doi: 10.1111/ajd.12877. Epub 2018 Jul 10. No abstract available. | |
| 27367303 | Background | Robinson JK, Wayne JD, Martini MC, Hultgren BA, Mallett KA, Turrisi R. Early Detection of New Melanomas by Patients With Melanoma and Their Partners Using a Structured Skin Self-examination Skills Training Intervention: A Randomized Clinical Trial. JAMA Dermatol. 2016 Sep 1;152(9):979-85. doi: 10.1001/jamadermatol.2016.1985. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Home sample collection arm participants were randomized into arm 1 at baseline | Posted | Count of Participants | Participants | 90 days |
|
two months after completing final 3-month survey of study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. June Robinson | Northwestern University Feinberg School of Medicine | 3129433703 | june-robinson@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 2, 2020 | Oct 25, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 31, 2020 | Nov 10, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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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
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| Active control:Healthy Living | Behavioral | 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. |
|
Self-reported responses to 7 items, each with a 5-point Likert scale (range 7-35) higher score = greater confidence (better outcome).
| 90 days |
| 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 | 5 months |
| Pathologic Diagnosis of Concerning Moles | Electronic medical record review of pathologic diagnosis of biopsied moles that participants identified as concerning | 5 months |
| Biopsy Performed | EMR review of physician performing a biopsy on a concerning mole identified by the participant, percentage of biopsies performed | 5 months |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| skin type | Count of Participants | Participants |
|
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. |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 90 days |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 90 days |
|
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | 90 days |
|
|
|
|
| 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 | Posted | Number | participants | 5 months |
|
|
|
|
| Secondary | Pathologic Diagnosis of Concerning Moles | Electronic medical record review of pathologic diagnosis of biopsied moles that participants identified as concerning | all participants in arm 3 had benign moles on the home sample collected | Posted | Number | participants | 5 months |
|
|
|
|
| Secondary | Biopsy Performed | EMR review of physician performing a biopsy on a concerning mole identified by the participant, percentage of biopsies performed | percentage of participants having a biopsy of a concerning mole | Posted | Number | percentage of participants having a biop | 5 months |
|
|
|
|
| 0 |
| 494 |
| 0 |
| 494 |
| 0 |
| 494 |
| EG001 | 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. | 0 | 495 | 0 | 495 | 0 | 495 |
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| stopped SSE |
|
| Clinical diagnosis melanoma |
|
| melanoma stage 0 |
|
| melanoma stage 1A |
|
| melanoma stage 1B |
|
| Superiority |