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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
June Robinson, Northwestern University
ClinicalTrials.gov Identifier:
NCT01432860
First received: August 15, 2011
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Melanoma
Behavioral: In-person counseling
Behavioral: Workbook
Behavioral: Tablet Computer-Based Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Screening
Official Title: A Comparison of Interventions to Teach Melanoma Patients Skin Self-examination

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Self-Efficacy in Performing SSE [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Accuracy [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Accurate identification of concerning lesions (melanoma) by participants performing SSE in comparison with the dermatologist's assessment.


Estimated Enrollment: 1000
Study Start Date: September 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: In-person Counseling and Education
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.
Behavioral: In-person counseling
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.
Active Comparator: Workbook
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 are randomized to this arms.
Behavioral: Workbook
Participants will read a workbook and perform skills training exercises.
No Intervention: Control
Education and counseling as usually delivered in clinical practice. 100 pairs are randomized to this arm.
Active Comparator: Tablet Computer-Based Education
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. 50 pairs will be randomized into this arm.
Behavioral: Tablet Computer-Based Education
Participants will receive their education from an interactive app designed for a tablet computer.

Detailed Description:

Population based registries document that survival from melanoma, a growing public health problem with approximately 70,000 new melanoma cases and an estimated 8,600 deaths in 2010, is dependent on the thickness of the melanoma. By facilitating seeking medical care, skin self-examinations (SSEs) by individuals with a prior history of melanoma, who are at risk to develop subsequent melanomas, may lead to the early detection and treatment of melanoma when it is usually more effective. Thus, further research that enhances early detection is warranted and our application directly tests novel methods of training high-risk melanoma patients and their partners on how to conduct SSEs to promote early detection. Our proposed research builds upon the strengths of the R21 that: a) established that in-person training to conduct SSE with a partner significantly enhanced SSE performance 4 months after the intervention, and b) developed and pilot tested a manualized take-home workbook training approach (WORKBOOK). Our pilot work on the WORKBOOK with partners suggests that patient-partner dyads (n = 21) perceived it to be readable, useful, and in the short term 4 month follow-up, empirically equivalent in promoting SSE knowledge, skills, and behaviors compared with patient-partner dyads in the in-person partner training condition (n = 19). Our proposed research builds on our NCI funded studies by conducting a formal examination with 430 subjects randomized to either the in-person or workbook training vs. an assessment only control group that receives standard of care over a 2 year longitudinal study with 4 month interval evaluations. An additional group of 50 subjects has been added to test a tablet computer-based program.

Our proposed research directly tests novel methods of training Stage I and IIB melanoma patients, who have a 5 year survival of 80-90%, and their partners, on how to conduct SSEs. We will compare the efficacy of the in-person training vs. workbook for patients and partners vs. controls on SSE knowledge/skill acquisition and retention, and SSE performance and accuracy on a short (4 and 8 months post baseline) and long term basis (12, 16, 20, and 24 months post baseline) and examine whether partner-patient relationship-qualities moderate the relationship between the training approaches and SSEs knowledge/skill acquisition and retention, and SSE performance and accuracy. The tablet computer-based program will also be tested for efficacy and compared with the previous groups.

Establishing health promotion partnerships is important to those at risk to develop melanoma because SSE is difficult to successfully perform as an individual. It is expected that the workbook will promote SSE at least as well as and perhaps better than in-person training and become an easily disseminated SSE training approach that is not dependent on the time and teaching skills of the non-MD clinical office staff.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1.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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01432860

Locations
United States, Illinois
Northwestern University Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: June K Robinson, MD Northwestern University
  More Information

No publications provided

Responsible Party: June Robinson, Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT01432860     History of Changes
Other Study ID Numbers: STU17005
Study First Received: August 15, 2011
Last Updated: September 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Skin Self Examination

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 20, 2014