Partner Assistance in Learning and Performing Skin Self-Examination

NCT ID: NCT01013844

Last Updated: 2014-10-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Solo Learning

Participant learning alone (without partner).

Group Type ACTIVE_COMPARATOR

Skin Self Examination Information and ABCDE Rule

Intervention Type 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

Participant and partner learning together.

Group Type ACTIVE_COMPARATOR

Skin Self Examination Information and ABCDE Rule

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Loyola University

OTHER

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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June Robinson

Professor of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dennis P West, PhD

Role: STUDY_DIRECTOR

Northwestern University

June K Robinson, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Loyola University

Maywood, Illinois, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18258332 (View on PubMed)

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.

Reference Type RESULT
PMID: 16618863 (View on PubMed)

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.

Reference Type RESULT
PMID: 17224540 (View on PubMed)

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.

Reference Type RESULT
PMID: 17147966 (View on PubMed)

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.

Reference Type RESULT
PMID: 18283179 (View on PubMed)

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.

Reference Type RESULT
PMID: 19289774 (View on PubMed)

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.

Reference Type RESULT
PMID: 19659978 (View on PubMed)

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.

Reference Type RESULT
PMID: 19380671 (View on PubMed)

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.

Reference Type RESULT
PMID: 19388140 (View on PubMed)

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.

Reference Type RESULT
PMID: 20083705 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24418949 (View on PubMed)

Other Identifiers

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2003-01

Identifier Type: -

Identifier Source: org_study_id

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Information Presentation Formats
NCT02267928 COMPLETED NA