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| Name | Class |
|---|---|
| Loyola University | OTHER |
| Dartmouth-Hitchcock Medical Center | OTHER |
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This study is a behavioral science study designed to identify aspects of the dyadic relationship that promote Skin Self-Examination (SSE) in patients at high risk of developing melanoma. The patient is randomized to receive the educational intervention either as a solo learner or with the partner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solo Learning | Active Comparator | Participant learning alone (without partner). |
|
| Dyadic Learning | Active Comparator | Participant and partner learning together. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin Self Examination Information and ABCDE Rule | Behavioral | Card with condensed information about skin self examination (SSE) and color illustrations of the ABCDE (asymmetry of shape, border irregularity, color variation, diameter > or equal to 6 mm, and evolution of the lesion) rule. A research assistant gave a skill demonstration using a magnifying lens. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Skin Examinations Without Partner Over 4 Months | Behavioral outcome was measured by assessing the number of times that participants examined their skin in the last 4 months. | 4 months |
| Mean Number of Skin Examinations With Partner Over 4 Months | Behavioral outcome was measured by assessing the number of times that participants examined their skin with a partner in the last 4 months. | 4 months |
| Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months | Behavioral outcome was measured by assessing the number of times that participants reviewed skin self examination guidelines in the last 4 months. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis P West, PhD | Northwestern University | Study Director |
| June K Robinson, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| Loyola University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18258332 | Background | Robinson JK, Stapleton J, Turrisi R. Relationship and partner moderator variables increase self-efficacy of performing skin self-examination. J Am Acad Dermatol. 2008 May;58(5):755-62. doi: 10.1016/j.jaad.2007.12.027. Epub 2008 Feb 6. | |
| 16618863 | Result | Robinson JK, Turrisi R. Skills training to learn discrimination of ABCDE criteria by those at risk of developing melanoma. Arch Dermatol. 2006 Apr;142(4):447-52. doi: 10.1001/archderm.142.4.447. |
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Participants were recruited from hospital registries of patients who were diagnosed as having cutaneous melanoma (CM) and were being seen at least annually by physicians for their skin conditions.
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| ID | Title | Description |
|---|---|---|
| FG000 | Solo Learning | Participant learning alone (without partner). |
| FG001 | Dyadic Learning | Participant and partner learning together. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Solo Learning | Participant learning alone (without partner). |
| BG001 | Dyadic Learning | Participant and partner learning together. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Mean Number of Skin Examinations Without Partner Over 4 Months | Behavioral outcome was measured by assessing the number of times that participants examined their skin in the last 4 months. | Mean | Standard Deviation | Times examined skin by self | 4 months |
|
4 months
130 subjects were enrolled in the study and 130 subjects were at risk.
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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 | Solo Learning | Participant learning alone (without partner). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| June Robinson, MD | Northwestern University Department of Dermatology | 312-695-6624 | june-robinson@northwestern.edu |
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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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|
| Maywood |
| Illinois |
| 60153 |
| United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| 17224540 | Result | Robinson JK, Turrisi R, Stapleton J. Efficacy of a partner assistance intervention designed to increase skin self-examination performance. Arch Dermatol. 2007 Jan;143(1):37-41. doi: 10.1001/archderm.143.1.37. |
| 17147966 | Result | Robinson JK, Turrisi R, Stapleton J. Examination of mediating variables in a partner assistance intervention designed to increase performance of skin self-examination. J Am Acad Dermatol. 2007 Mar;56(3):391-7. doi: 10.1016/j.jaad.2006.10.028. Epub 2006 Dec 4. |
| 18283179 | Result | Glanz K, Yaroch AL, Dancel M, Saraiya M, Crane LA, Buller DB, Manne S, O'Riordan DL, Heckman CJ, Hay J, Robinson JK. Measures of sun exposure and sun protection practices for behavioral and epidemiologic research. Arch Dermatol. 2008 Feb;144(2):217-22. doi: 10.1001/archdermatol.2007.46. |
| 19289774 | Result | Robinson JK, Ortiz S. Use of photographs illustrating ABCDE criteria in skin self-examination. Arch Dermatol. 2009 Mar;145(3):332-3. doi: 10.1001/archdermatol.2008.604. No abstract available. |
| 19659978 | Result | Boone SL, Stapleton J, Turrisi R, Ortiz S, Robinson JK, Mallett KA. Thoroughness of skin examination by melanoma patients: influence of age, sex and partner. Australas J Dermatol. 2009 Aug;50(3):176-80. doi: 10.1111/j.1440-0960.2009.00533.x. |
| 19380671 | Result | Robinson JK, Mallett KA, Turrisi R, Stapleton J. Engaging patients and their partners in preventive health behaviors: the physician factor. Arch Dermatol. 2009 Apr;145(4):469-73. doi: 10.1001/archdermatol.2009.2. No abstract available. |
| 19388140 | Result | Robinson JK, Mallett KA. The duty to inspect the skin and counsel those at risk to develop melanoma. JAMA. 2009 Apr 22;301(16):1702-4. doi: 10.1001/jama.2009.542. No abstract available. |
| 20083705 | Result | Robinson JK, Turrisi R, Mallett K, Stapleton J, Pion M. Comparing the efficacy of an in-person intervention with a skin self-examination workbook. Arch Dermatol. 2010 Jan;146(1):91-4. doi: 10.1001/archdermatol.2009.350. No abstract available. |
| 24418949 | Derived | Robinson JK, Gaber R, Hultgren B, Eilers S, Blatt H, Stapleton J, Mallett K, Turrisi R, Duffecy J, Begale M, Martini M, Bilimoria K, Wayne J. Skin self-examination education for early detection of melanoma: a randomized controlled trial of Internet, workbook, and in-person interventions. J Med Internet Res. 2014 Jan 13;16(1):e7. doi: 10.2196/jmir.2883. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participant learning alone (without partner).
| OG003 | Dyadic Learning Immediate Follow-up | Participant and partner learning together. |
| OG004 | Solo Learning 4-Month Follow-up | Participant learning alone (without partner). |
| OG005 | Dyadic Learning 4-Month Follow-up | Participant and partner learning together. |
|
|
| Primary | Mean Number of Skin Examinations With Partner Over 4 Months | Behavioral outcome was measured by assessing the number of times that participants examined their skin with a partner in the last 4 months. | Mean | Standard Deviation | Times examined skin with a partner | 4 months |
|
|
|
| Primary | Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months | Behavioral outcome was measured by assessing the number of times that participants reviewed skin self examination guidelines in the last 4 months. | Mean | Standard Deviation | Number of times reviewed SSE guidelines | 4 months |
|
|
|
| 0 |
| 65 |
| 0 |
| 65 |
| EG001 | Dyadic Learning | Participant and partner learning together. | 0 | 65 | 0 | 65 |
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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 |