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Completed

NCT Number: NCT01013844

Partner Assistance in Learning and Performing Skin Self-Examination

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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Dartmouth-Hitchcock Medical Center
  • Loyola University

Registry information

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Nov 16, 2009
Registry last updated
Oct 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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