Partner Assistance in Learning and Performing Skin Self-Examination

NCT01013844 | Completed Results

• 1 other identifier: 2003-01
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 3

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.

Conditions

Melanoma

Keywords

skin self-examination; SSE; melanoma

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Solo Learning

ACTIVE COMPARATOR

Participant learning alone (without partner).

Behavioral: Skin Self Examination Information and ABCDE Rule

Dyadic Learning

ACTIVE COMPARATOR

Participant and partner learning together.

Behavioral: Skin Self Examination Information and ABCDE Rule

Interventions

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.

Dyadic Learning; Solo Learning

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• to 70 years old with a spouse or cohabitating partner

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Loyola University: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator

Study Sites (3)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Loyola University

Maywood, Illinois, 60153, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (11)

• 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.

  PMID: 18258332 BACKGROUND

• 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.

  PMID: 16618863 RESULT

• 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.

  PMID: 17224540 RESULT

• 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.

  PMID: 17147966 RESULT

• 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.

  PMID: 18283179 RESULT

• 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.

  PMID: 19289774 RESULT

• 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.

  PMID: 19659978 RESULT

• 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.

  PMID: 19380671 RESULT

• 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.

  PMID: 19388140 RESULT

• 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.

  PMID: 20083705 RESULT

• 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.

  PMID: 24418949 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: June Robinson, MD
• Organization: Northwestern University Department of Dermatology

june-robinson@northwestern.edu

312-695-6624

Study Officials

• Dennis P West, PhD

  Northwestern University

  STUDY DIRECTOR

• June K Robinson, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Study Record Dates

• First Submitted: November 11, 2009
• First Posted: November 16, 2009
• Study Start: December 1, 2003
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: October 2, 2014
• Results First Posted: March 10, 2011

Record last verified: 2014-09

Locations

US (3)