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Clinical Trials/NCT01013844
NCT01013844CompletedNot Applicable

Partner Assistance in Learning and Performing Skin Self-Examination

Northwestern University6 sites in 1 country130 target enrollmentStarted: December 2003Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
130
Locations
6
Primary Endpoint
Mean Number of Skin Examinations Without Partner Over 4 Months

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Mean Number of Skin Examinations Without Partner Over 4 Months

Time Frame: 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

Time Frame: 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

Time Frame: 4 months

Behavioral outcome was measured by assessing the number of times that participants reviewed skin self examination guidelines in the last 4 months.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

June Robinson

Professor of Dermatology

Northwestern University

Study Sites (6)

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