Partner Assistance in Learning and Performing Skin Self-Examination - Full Text View

Purpose

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.

Condition	Intervention
Melanoma	Behavioral: Skin Self Examination Information and ABCDE Rule

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Partner Assistance in Learning and Performing Skin Self-Examination

Resource links provided by NLM:

MedlinePlus related topics: Melanoma

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

Mean Number of Skin Examinations Without Partner Over 4 Months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Behavioral outcome was measured by assessing the number of times that participants reviewed skin self examination guidelines in the last 4 months.

Enrollment:	130
Study Start Date:	December 2003
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Solo Learning Participant learning alone (without partner).	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.
Active Comparator: Dyadic Learning Participant and partner learning together.	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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013844

Locations

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Loyola University
Maywood, Illinois, United States, 60153
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756

Sponsors and Collaborators

Northwestern University

Loyola University

Dartmouth-Hitchcock Medical Center

Investigators

Study Director:	Dennis P West, PhD	Northwestern University
Principal Investigator:	June K Robinson, MD	Northwestern University

More Information

Publications:

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.

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.

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.

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.

Robinson JK, Ortiz S. Use of photographs illustrating ABCDE criteria in skin self-examination. Arch Dermatol. 2009 Mar;145(3):332-3. No abstract available.

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.

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. No abstract available.

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. No abstract available.

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. No abstract available.

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. Epub 2008 Feb 6.

Responsible Party:	June Robinson, Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier:	NCT01013844 History of Changes
Other Study ID Numbers:	2003-01
Study First Received:	November 11, 2009
Results First Received:	December 3, 2010
Last Updated:	July 31, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Northwestern University:

skin self-examination
SSE
melanoma

Additional relevant MeSH terms:

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on May 19, 2013