A Comparison of Interventions to Teach Melanoma Patients Skin Self-examination
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional

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.
    

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 pairs (860 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 70 pairs (140 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.
    

Intervention name(s): In-person counseling; Workbook; Tablet Computer-Based Education
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; Participants will read a workbook and perform skills training exercises.; Participants will receive their education from an interactive app designed for a tablet computer.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Screening
Keywords: Skin Self Examination