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| Name | Class |
|---|---|
| Sarah M. Friedewald, MD | UNKNOWN |
| Jennifer N. Choi, MD | UNKNOWN |
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The skin self-examination for melanoma (SSE) educational materials were developed with the input provided by women undergoing screening mammograms. The investigators seek to evaluate the performance of SSE by women and find out if women seek care with a dermatologist for a concerning mole or for a melanoma screening examination by a dermatologist after reviewing the materials received during the mammogram visit. The purpose of this study is to enhance the early detection of melanoma among women who are engaging in health promotion by having mammograms. The investigators specifically aim to evaluate the performance of SSE by women, who receive information during their mammogram appointment, and then follow-up with dermatology for a melanoma screening examination.
The proposed study is the second phase of a project assessing the feasibility and effectiveness of enhancing the early detection of melanomas among women, who are engaging in health promotion by having mammograms. The initial phase of the project framed risk messages, developed posters and brochures with the input provided by women undergoing screening mammograms, and assessed the feasibility of delivering the program during the mammogram visit at the Lynn Sage Comprehensive Breast Center of Northwestern Medicine/ Prentice Women's Hospital. The investigators seek to evaluate performance of skin self-examination (SSE) by women, who receive information during their mammogram appointment, and follow-up with dermatology for a melanoma screening examination. In the second phase, a more intensive intervention in which women will not only receive information about SSE, but will also receive a reminder to perform SSE one week after the screening mammogram and information on how to schedule an appointment with dermatology will be provided. The number of women who perform SSE at home and find a concerning mole (lesion), number who see a dermatologist, and number who have a concerning lesion biopsied will be compared in two arms of the study 1) women who receive the intensive intervention 2) women who receive the informational brochure about SSE alone. The hypothesis is that women who receive more the intensive educational intervention will be more likely to perform SSE at home and schedule a follow-up dermatologist appointment as compared to those who receive the information brochure alone. This project builds upon Robinson's successful SSE training program for melanoma patients that resulted in patients' accurate evaluations of suspicious lesions relative to dermatologists' skin examinations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Intervention | Experimental | Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week to perform SSE. |
|
| Minimal Intervention | Active Comparator | Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week to perform SSE. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimal Intervention | Behavioral | Women view an educational poster in changing room, and they receive a brochure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Performed a Skin Self-Examination at 3-months | The percentage of participants that performed skin self-examination at the 3-month time interval. | 3-months |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Melanomas Determined by Dermatologist Review of Concerning Lesion | The total number of melanomas identified by a dermatologist in women who found a concerning mole | 7-months |
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Inclusion Criteria:
Exclusion Criteria:
Women waiting to have a mammogram
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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 |
|---|---|---|---|
| 29234713 | Result | Rzepecki AK, Jain N, Ali Y, Chavez L, Choi J, Schlosser B, Liko-Hazizi E, Friedewald SM, Robinson JK. Promoting early detection of melanoma during the mammography experience. Int J Womens Dermatol. 2017 Jul 5;3(4):195-200. doi: 10.1016/j.ijwd.2017.06.002. eCollection 2017 Dec. | |
| 32328556 | Result | Robinson JK, Perez M, Abou-El-Seoud D, Kim K, Brown Z, Liko-Hazizi E, Friedewald SM, Kwasny M, Spring B. Targeted Melanoma Screening: Risk Self-Assessment and Skin Self-Examination Education Delivered During Mammography of Women. JNCI Cancer Spectr. 2019 Jun 28;3(3):pkz047. doi: 10.1093/jncics/pkz047. eCollection 2019 Sep. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intensive Intervention | Participants receive brochure, card advising how to make an appointment with dermatology, and reminder by telephone, text message or email in one week to perform SSE. Intensive Intervention: Women view an educational poster in changing room, and they receive a brochure. |
| FG001 | Minimal Intervention | Participants receive brochure, card advising how to make an appointment with dermatology. Minimal Intervention: Women view an educational poster in changing room, and they receive a brochure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Women having a screening mammogram completed a baseline self-report of prior skin self-examination prior to the intervention
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| ID | Title | Description |
|---|---|---|
| BG000 | Intensive Intervention | Participants receive brochure, card advising how to make an appointment with dermatology, and reminder by telephone, text message or email in one week to perform SSE. Intensive Intervention: Women view an educational poster in changing room, and they receive a brochure. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 That Performed a Skin Self-Examination at 3-months | The percentage of participants that performed skin self-examination at the 3-month time interval. | Women performing skin self-examination as reported 3 months after the intervention | Posted | Count of Participants | Participants | 3-months |
|
7 months
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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 | Intensive Intervention | Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week by telephone call, text message or email to perform SSE. Intensive Intervention: Women view an educational poster in changing room, and they receive a brochure. |
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Limitations of our study include a relatively short duration of follow-up resulting in a modest number of incident invasive melanoma cases and a lack of participant blinding of allocation to intervention arms.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. June Robinson | Northwestern University | 312-503-5941 | 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 | May 18, 2018 | Mar 11, 2019 | Prot_SAP_000.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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study arm not disclosed
| Intensive Intervention | Behavioral | Women view an educational poster in changing room, and they receive a brochure. |
|
| 32090289 | Derived | Robinson JK, Brown Z, Spring B. Melanoma Skin Self-Examination Education During Mammography: Health Burden of Women Impairs Implementation. J Cancer Educ. 2021 Aug;36(4):858-864. doi: 10.1007/s13187-020-01714-4. |
| Minimal Intervention |
Participants receive brochure, card advising how to make an appointment with dermatology. Minimal Intervention: Women view an educational poster in changing room, and they receive a brochure. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Number of participants who had ever conducted skin self-examination prior to study participation | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Total Number of Melanomas Determined by Dermatologist Review of Concerning Lesion | The total number of melanomas identified by a dermatologist in women who found a concerning mole | Women who found a concerning mole at month 1 and month 3 and proceeded to have a skin examination by a dermatologist | Posted | Number | Melanomas | 7-months |
|
|
|
|
| 0 |
| 195 |
| 0 |
| 195 |
| 0 |
| 195 |
| EG001 | Minimal Intervention | Participants receive brochure, card advising how to make an appointment with dermatology. Minimal Intervention: Women view an educational poster in changing room, and they receive a brochure. | 0 | 225 | 0 | 225 | 0 | 225 |
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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 |