An interventional study of SSE educational intervention and Active control:Healthy Living in Melanoma, sponsored by Northwestern University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-23.
Sponsored by Northwestern University · Not applicable, Interventional, and Prevention
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 1,000 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
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Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
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Inclusion criteria of skin check partner, who may be a man or a woman, to have mole self-sampled
Exclusion Criteria:
Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
Behavioral: SSE educational intervention
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.
Behavioral: Active control:Healthy Living
Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
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.
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
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
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
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
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
Pathologic Diagnosis of Concerning Moles
Electronic medical record review of pathologic diagnosis of biopsied moles that participants identified as concerning
Time frame: 5 months
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
| Milestone | SSE Educational Intervention | Active Control: Healthy Living |
|---|---|---|
| Started | 501 | 499 |
| Completed | 390 | 414 |
| Not completed | 111 | 85 |
Self-reported performance of SSE, a custom scale with the frequency and extent of SSE is completed in an online monthly survey
| Participants | SSE Educational Intervention | Active Control: Healthy Living |
|---|---|---|
| baseline ever perform SSE | 217 | 242 |
| 1-mo perform SSE | 475 | 238 |
| 2-mo perform SSE | 355 | 228 |
| 3-mo perform SSE | 348 | 211 |
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.
| Participants | SSE Educational Intervention | Active Control: Healthy Living |
|---|---|---|
| Made physician appointment | 39 | 107 |
| Followed mole for change | 239 | 7 |
| stopped SSE | 0 | 30 |
Self-reported responses to 6 items, each with a 5-point Likert scale (range 6-30) higher score= more anxiety, a worse outcome
| units on a scale | SSE Educational Intervention | Active Control: Healthy Living |
|---|---|---|
| Baseline | 6.4 ± 0.05 | 6.4 ± 0.05 |
| Follow-up month 3 | 6.6 ± 0.05 | 6.6 ± 0.05 |
Self-reported responses to 7 items, each with a 5-point Likert scale (range 7-35) higher score = greater confidence (better outcome).
| units on a scale | SSE Educational Intervention | Active Control: Healthy Living |
|---|---|---|
| Baseline | 9.3 ± 0.05 | 9.3 ± 0.05 |
| Follow-up-3 month | 11.6 ± 0.05 | 10.0 ± 0.05 |
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 | SSE Educational Intervention | Active Control: Healthy Living |
|---|---|---|
| Clinical diagnosis benign | 14 | 93 |
| Clinical diagnosis atypical nevus | 15 | 9 |
| Clinical diagnosis melanoma | 10 | 5 |
Electronic medical record review of pathologic diagnosis of biopsied moles that participants identified as concerning
| participants | SSE Educational Intervention | Active Control: Healthy Living |
|---|---|---|
| benign nevus | 0 | 1 |
| atypical nevus | 13 | 6 |
| melanoma stage 0 | 5 | 3 |
| melanoma stage 1A | 4 | 3 |
| melanoma stage 1B | 0 | 1 |
EMR review of physician performing a biopsy on a concerning mole identified by the participant, percentage of biopsies performed
| percentage of participants having a biop | SSE Educational Intervention | Active Control: Healthy Living |
|---|---|---|
| Biopsy Performed | 56.4 | 13.1 |
Collected over two months after completing final 3-month survey of study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SSE Educational Intervention | 0/494 (0%) | 0/494 (0%) | 0/494 (0%) |
| Active Control: Healthy Living | 0/495 (0%) | 0/495 (0%) | 0/495 (0%) |
| Age, Categorical(Participants) | SSE Educational Intervention | Active Control: Healthy Living | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 494 | 495 | 989 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | SSE Educational Intervention | Active Control: Healthy Living | Total |
|---|---|---|---|
| Median | 47.0 (41.2 to 54.0) | 47.0 (41.0 to 53.3) | 47.0 (41.1 to 53.7) |
| Sex: Female, Male(Participants) | SSE Educational Intervention | Active Control: Healthy Living | Total |
|---|---|---|---|
| Female | 494 | 495 | 989 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | SSE Educational Intervention | Active Control: Healthy Living | Total |
|---|---|---|---|
| Hispanic or Latino | 37 | 36 | 73 |
| Not Hispanic or Latino | 457 | 459 | 916 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | SSE Educational Intervention | Active Control: Healthy Living | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 3 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 485 | 480 | 965 |
| More than one race | 2 | 5 | 7 |
| Unknown or Not Reported | 3 | 6 | 9 |
| skin type(Participants) | SSE Educational Intervention | Active Control: Healthy Living | Total |
|---|---|---|---|
| I (always sunburn, never tan) | 29 | 22 | 51 |
| II (usually sunburn, tan minimally) | 213 | 230 | 443 |
| III (sometimes sunburn, tan moderately) | 216 | 200 | 416 |
| IV(rarely sunburn, tan deeply) | 36 | 43 | 79 |
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