Teaching Skin Self -Examination to Melanoma Patients and Their Skin Check Partners
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional

Summary: 
      The proposed study is a continuation of a research program (STU00017005: Interventions to
      teach melanoma patients skin self-examination) designed to increase early detection of
      melanomas before they metastasize. In 2015, approximately 73,870 individuals in the U.S. will
      be diagnosed with invasive melanoma and about 9,940 will die from the disease. During
      2002-2011, melanoma incidence increased at an average annual rate of 1.6% for men and 1.5%
      for women. People with a history of melanoma have a 10 times greater risk of developing a
      second primary melanoma relative to the general population. Early detection with surgical
      excision at an earlier stage when treatment is usually more effective is the only proven
      curative strategy.

      Relationship factors to help sustain skin self-examination will also be evaluated.

      The study has been amended to include an administrative supplement, which builds upon the
      pilot research completed during the summer of 2017 that measured the efficacy of two wearable
      UV sensors (Shade and Wearifi) and a survey assessing sun protection along with the quality
      of life. See Detailed Description for a description of amendment addition.

      This research was expanded to distance (remote) learning provided by mailing the same
      workbook used in the in-office training.
    

Detailed description: 
      The completed R01 demonstrated preliminary evidence for a melanoma survivor and partner skin
      self-examination (SSE) training program resulting in regular and accurate SSEs relative to
      patients and partners receiving treatment as usual care. However, one caveat is that the
      patients and partners in the well-controlled study are potentially being cued to conduct the
      SSEs following training and reinforced for their actions. Whereas in "real-world" conditions
      the participants would see their dermatologist less frequently with significantly less cueing
      to conduct SSEs.

      This research addresses this limitation by examining the long-term influence of SSE training
      on SSE knowledge, self-efficacy, performance, and accuracy under real-world conditions for
      melanoma patients in the treatment group from the ongoing R01 study relative to controls (Aim
      1). In addition, the continuation study will also examine for whom the intervention works
      best under real-world conditions (Aim 2). Findings from clinical RCTs of behavioral
      interventions involving patients are rarely if ever, examined to determine generalizability
      to real-world settings. The current proposal will contribute critical information to the
      scientific literature on the impact of early detection of melanomas using SSEs and will be
      the first to test the sustainability and long-term impact of an efficacious SSE intervention
      for early detection targeting melanoma survivors in real-world settings. Relationship factors
      to help sustain skin self-examination will also be evaluated.

      The amended part of the study is an administrative supplement, which builds upon the pilot
      research completed during the summer of 2017 that measured the efficacy of two wearable UV
      sensors (Shade and Wearifi) and a survey assessing sun protection along with the quality of
      life. The Shade sensor provided a more reliable time-stamped assessment. With the use of the
      Daily Minutes of Unprotected Sun Exposure Inventory (MUSE) and the Shade sensors, the
      investigators assessed the sun protection behaviors of melanoma survivors and found that 13%
      of the melanoma survivors were surprised by their amount of UV exposure.

      The investigators now wish to determine the feasibility of simultaneously obtaining wearable
      sensor data for physical activity (ActiGraph) and the Shade sensor and completion of
      self-reported surveys for the same time period. The feasibility and methodological
      information derived from this project are highly relevant to capture and quantify UV exposure
      among physically active individuals.

      A total of 40 participants will be recruited for this phase (324 from initial study + 40 from
      amended section = 364 anticipated total).Ten participants (5 melanoma survivors and 5 young
      adult relatives), testing the feasibility of wearing two sensors and completing daily online
      surveys. After feasibility testing, the study will enroll melanoma survivors, age 18-70
      years, with Stages 0-1A (n=15) and their young adult relatives (n=15) who are 18-39 years
      old. The sex of enrolled participants will be monitored to assure equivalent numbers of male
      and female participants.

      Two arms were added: a) Feasibility of wearing 2 sensors, and b) Feasibility of completing
      online daily survey. The research team will strive to integrate event level data in
      real-time. At the conclusion of the study, participants receive a report of their UV exposure
      and physical activity over the 7 days of the study. Eligibility Criteria has also been
      updated for the amended portion of the study.

      Distance (remote) learning will be compared with in-person learning with online surveys
      assessing SSE knowledge, confidence, anxiety and performance. Electronic health record review
      will identify biopsies of concerning moles and the number and stage of melanomas identified.
    

Intervention name(s): Skin Self- examination structured training
Intervention type(s): Behavioral
Intervention description(s): A PowerPoint presentation will be provided as a PDF file. The file will be available in English and Spanish. This is the same skin self-examination structured training intervention used in the original RCT (MoleScore)
Other intervention name(s): MoleScore
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: melanoma; skin self-examination