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

18 Years
80 Years
Open (Enrolling)

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Trial Information

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

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.

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Screening

Outcome Measure:

Self-Efficacy in Performing SSE

Outcome Description:

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.

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

June K Robinson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University


United States: Institutional Review Board

Study ID:




Start Date:

September 2011

Completion Date:

August 2015

Related Keywords:

  • Melanoma
  • Skin Self Examination
  • Melanoma



Northwestern University Department of DermatologyChicago, Illinois  60611