A Comparison of Interventions to Teach Melanoma Patients Skin Self-examination

NCT01432860 | Completed DMC

• 1 other identifier: STU17005
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The almost 724,000 Americans survivors of melanoma are estimated to have 4 first degree relatives per case; thus, 2.8 million Americans are at increased risk of developing melanoma in comparison to the general public. Skin self-examination (SSE) with the assistance of a partner by these individuals could improve survival. If effective, the workbook tested in this proposal could be distributed to people at risk of developing melanoma by large scale means in physicians office.

Conditions

Melanoma

Keywords

Skin Self Examination

Outcome Measures

Primary Outcomes (1)

• Self-Efficacy in Performing SSE

  To compare the self-efficacy of the in-person training vs. workbook for patients and partners by self-report on a survey at 4-month intervals over 24 months.

  24 months

Secondary Outcomes (1)

• Accuracy

  24 months

Study Arms (4)

In-person Counseling and Education

ACTIVE COMPARATOR

In the in-person training the Research Assistant demonstrates the use of a mm ruler, a lighted magnifying lens, a set of body maps and a scorecard, 4 pens, ABCDE rule on the skin exam card and discusses the ABCDE rule by pointing to the color examples on the skin exam card. 165 pairs (330 subjects) are randomized to this arm.

Behavioral: In-person counseling

Workbook

ACTIVE COMPARATOR

The workbook, which includes all of the information delivered in the in-person intervention, is 39 pages in length, and has 76 color figures. Each element of the in-person training represents a chapter in the workbook. The introduction explores the partners' understanding of melanoma and their personal risk of developing another melanoma, and attitudes about the benefit of early detection assisted by a partner. The early detection segment uses a skin diagram to illustrate the difference between thin and thick melanoma and presents the treatment based on the depth of the melanoma. 165 pairs (330 subjects) are randomized to this arm.

Behavioral: Workbook

Control

NO INTERVENTION

Education and counseling as usually delivered in clinical practice. 100 pairs (200 subjects) are randomized to this arm.

Tablet Computer-Based Education

ACTIVE COMPARATOR

Education will be given by an interactive tablet app. Each pair will view video recordings of certain parts of the in-person presentation as well as select slides from the in-person PowerPoint presentation. Parts of the workbook will be incorporated as well. 70 pairs (140 subjects) are randomized into this arm.

Behavioral: Tablet Computer-Based Education

Interventions

In-person counseling BEHAVIORAL

The design is a 3 \[in-person training of patients and partners (PARTNER) vs. workbook training of patients and partners (WORKBOOK) vs. an assessment only group that receives education and treatment as usual care\] X 7 \[baseline, 4, 8, 12, 16, 20, and 24 month follow-up\] study. Standard education of melanoma patients, which are to be performed with the study partner, includes a recommendation to check moles and mark ones to remember on a body map. All participants receive the same measures and will be recruited using the same procedures, thus, yielding equivalence across conditions. Pairs will observe how to use their skin check tools and be asked to demonstrate their competence in using them.

In-person Counseling and Education

Workbook BEHAVIORAL

Participants will read a workbook and perform skills training exercises.

Workbook

Tablet Computer-Based Education BEHAVIORAL

Participants will receive their education from an interactive app designed for a tablet computer.

Tablet Computer-Based Education

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Personal history of Stage 0 through IIB melanoma
• At least 6 weeks post surgical treatment of Stage 0 through IIA melanoma
• Age 18-80 years old
• Have sufficient vision to read a newspaper in order to visually detect changes on skin
• Able to read English
• Have a partner willing to participate in skin checks

You may not qualify if:

• Subjects overburdened with other co- morbid diseases, medical treatments (e.g. chemotherapy), unable to participate in a conversation at a sixth grade language level due to cognitive impairment (e.g. by a stroke), or prior participation in SSE research.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Related Publications (7)

• Hultgren BA, Turrisi R, Mallett KA, Ackerman S, Robinson JK. Influence of Quality of Relationship Between Patient With Melanoma and Partner on Partner-Assisted Skin Examination Education: A Randomized Clinical Trial. JAMA Dermatol. 2016 Feb;152(2):184-90. doi: 10.1001/jamadermatol.2015.2819.

  PMID: 26422745 BACKGROUND

• Robinson JK, Wayne JD, Martini MC, Hultgren BA, Mallett KA, Turrisi R. Early Detection of New Melanomas by Patients With Melanoma and Their Partners Using a Structured Skin Self-examination Skills Training Intervention: A Randomized Clinical Trial. JAMA Dermatol. 2016 Sep 1;152(9):979-85. doi: 10.1001/jamadermatol.2016.1985.

  PMID: 27367303 BACKGROUND

• Stapleton JL, Turrisi R, Mallett KA, Robinson JK. Correspondence between pigmented lesions identified by melanoma patients trained to perform partner-assisted skin self-examination and dermatological examination. Cancer Epidemiol Biomarkers Prev. 2015 Aug;24(8):1247-53. doi: 10.1158/1055-9965.EPI-15-0218. Epub 2015 Jun 10.

  PMID: 26063475 RESULT

• Turrisi R, Hultgren B, Mallett KA, Martini M, Robinson JK. Comparison of Efficacy of Differing Partner-Assisted Skin Examination Interventions for Melanoma Patients: A Randomized Clinical Trial. JAMA Dermatol. 2015 Sep;151(9):945-51. doi: 10.1001/jamadermatol.2015.0690.

  PMID: 26049533 RESULT

• Rikki G, Brittney H, Jerod S, Mallett Kimberly A, Rob T, Claudia H, Karl B, Wayne Jeffrey D, Martini Mary C, Robinson June K. The Influence of Disease Perceptions on the Participation of Melanoma Patients and their Partners in Skin Self-Examination Education. J Community Med Health Educ. 2013 Nov 1;3(6):242. doi: 10.4172/2161-0711.1000242.

  PMID: 24795843 RESULT

• Gaber R, Mallett KA, Hultgren B, Turrisi R, Gilbertsen ML, Martini MC, Robinson JK. Enhanced fidelity of an educational intervention on skin self-examination through surveillance and standardization. J Nurs Educ Pract. 2014;4(2):253-258. doi: 10.5430/jnep.v4n2p253.

  PMID: 25414761 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 RESULT

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

Study Officials

• June K Robinson, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: September 13, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 12, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)