Partner Assistance in Learning and Performing Skin Self-Examination

Melanoma Clinical Trial

Official title:

Partner Assistance in Learning and Performing Skin Self-Examination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01013844
• Other study ID #: 2003-01
• Status: Completed
• Phase: N/A
• First received: November 11, 2009
• Last updated: September 24, 2014
• Start date: December 2003
• Est. completion date: November 2010

Study information

• Verified date: September 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Melanoma

Intervention

Behavioral:
• Skin Self Examination Information and ABCDE Rule
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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Loyola University	Maywood	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	Dartmouth-Hitchcock Medical Center, Loyola University

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. do — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Dec 4. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	4 months	No
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.	4 months	No
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.	4 months	No