Clinical trial NCT01013844: Partner Assistance in Learning and Performing Skin Self-Examination
Official title: Partner Assistance in Learning and Performing Skin Self-Examination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Keywords: skin self-examination
SSE
melanoma
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Loyola University
name: Dartmouth-Hitchcock Medical Center
First posted: 2009-11-16
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Mean Number of Skin Examinations Without Partner Over 4 Months
timeFrame: 4 months
measure: Mean Number of Skin Examinations With Partner Over 4 Months
timeFrame: 4 months
measure: Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Maywood
country: United States
facility: Loyola University
state: Illinois
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Northwestern University
name: Dennis P West, PhD
role: STUDY_DIRECTOR
affiliation: Northwestern University
name: June K Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1001/archderm.142.4.447.
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. doi: 10.1001/archderm.143.1.37.
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. doi: 10.1016/j.jaad.2006.10.028. Epub 2006 Dec 4.
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. doi: 10.1001/archdermatol.2007.46.
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. No abstract available.
citation: 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.
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. No abstract available.
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. doi: 10.1001/jama.2009.542. No abstract available.
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. No abstract available.
citation: Robinson JK, Gaber R, Hultgren B, Eilers S, Blatt H, Stapleton J, Mallett K, Turrisi R, Duffecy J, Begale M, Martini M, Bilimoria K, Wayne J. Skin self-examination education for early detection of melanoma: a randomized controlled trial of Internet, workbook, and in-person interventions. J Med Internet Res. 2014 Jan 13;16(1):e7. doi: 10.2196/jmir.2883.