Partner Assistance in Learning and Performing Skin Self-Examination

Not Applicable

Completed

• Conditions: Melanoma
• Interventions: Behavioral: Skin Self Examination Information and ABCDE Rule

• Registration Number: NCT01013844
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2009-11-11
• Study First Submitted QC: 2009-11-13
• Study First Posted: 2009-11-16
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Results First Submitted: 2010-12-03
• Results First Submitted QC: 2011-02-11
• Results First Posted: 2011-03-10
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-24
• Last Update Posted: 2014-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Solo Learning	Skin Self Examination Information and ABCDE Rule	Participant learning alone (without partner).
Dyadic Learning	Skin Self Examination Information and ABCDE Rule	Participant and partner learning together.

Primary Outcome Measures

Name	Time	Method
Mean Number of Skin Examinations Without Partner Over 4 Months	4 months	Behavioral outcome was measured by assessing the number of times that participants examined their skin in the last 4 months.
Mean Number of Skin Examinations With Partner Over 4 Months	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 Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months	4 months	Behavioral outcome was measured by assessing the number of times that participants reviewed skin self examination guidelines in the last 4 months.

Trial Locations

Locations (3)

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Loyola University; 🇺🇸 Maywood, Illinois, United States

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States