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Partner Assistance in Learning and Performing Skin Self-Examination

Primary Purpose

Melanoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Skin Self Examination Information and ABCDE Rule
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Melanoma focused on measuring skin self-examination, SSE, melanoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University
  • Loyola University
  • Dartmouth Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Solo Learning

Dyadic Learning

Arm Description

Participant learning alone (without partner).

Participant and partner learning together.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 11, 2009
Last Updated
September 24, 2014
Sponsor
Northwestern University
Collaborators
Loyola University, Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01013844
Brief Title
Partner Assistance in Learning and Performing Skin Self-Examination
Official Title
Partner Assistance in Learning and Performing Skin Self-Examination
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Loyola University, Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
skin self-examination, SSE, melanoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Solo Learning
Arm Type
Active Comparator
Arm Description
Participant learning alone (without partner).
Arm Title
Dyadic Learning
Arm Type
Active Comparator
Arm Description
Participant and partner learning together.
Intervention Type
Behavioral
Intervention Name(s)
Skin Self Examination Information and ABCDE Rule
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Number of Skin Examinations Without Partner Over 4 Months
Description
Behavioral outcome was measured by assessing the number of times that participants examined their skin in the last 4 months.
Time Frame
4 months
Title
Mean Number of Skin Examinations With Partner Over 4 Months
Description
Behavioral outcome was measured by assessing the number of times that participants examined their skin with a partner in the last 4 months.
Time Frame
4 months
Title
Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months
Description
Behavioral outcome was measured by assessing the number of times that participants reviewed skin self examination guidelines in the last 4 months.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis P West, PhD
Organizational Affiliation
Northwestern University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
June K Robinson, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Loyola University
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18258332
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.
Results Reference
background
PubMed Identifier
16618863
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.
Results Reference
result
PubMed Identifier
17224540
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.
Results Reference
result
PubMed Identifier
17147966
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.
Results Reference
result
PubMed Identifier
18283179
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.
Results Reference
result
PubMed Identifier
19289774
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.
Results Reference
result
PubMed Identifier
19659978
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.
Results Reference
result
PubMed Identifier
19380671
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.
Results Reference
result
PubMed Identifier
19388140
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.
Results Reference
result
PubMed Identifier
20083705
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.
Results Reference
result
PubMed Identifier
24418949
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.
Results Reference
derived

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Partner Assistance in Learning and Performing Skin Self-Examination

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