Partner Assistance in Learning and Performing Skin Self-Examination

Study Overview
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Brief Summary
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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.

Official Title
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Partner Assistance in Learning and Performing Skin Self-Examination

Conditions
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Melanoma

Intervention / Treatment
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* Behavioral: Skin Self Examination Information and ABCDE Rule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Personal or family history of melanoma. If a personal history of melanoma, the patient was treated at least 1 month ago Evidence of dysplastic nevus syndrome or a large number of moles (Greater than 50) Able to see to read a newspaper, can read at an eighth grade level Speaks English 18 to 70 years old with a spouse or cohabitating partner Exclusion Criteria: Under 18 years of age Patient overburden by other co-morbid diseases such as chronic immunosuppression from organ transplantation Have insufficient vision to to read a newspaper Unable to read English Have insufficient cognitive skills to follow instructions provided at an eighth grade language level

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Solo Learning<br>Participant learning alone (without partner). | Behavioral: Skin Self Examination Information and ABCDE Rule<br>* 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.<br>|
| Active Comparator: Dyadic Learning<br>Participant and partner learning together. | Behavioral: Skin Self Examination Information and ABCDE Rule<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin self-examination, SSE, melanoma