Patient case: 72-year-old male with melanoma; genetic feature: TP53 loss of function

Clinical trial: Teaching Skin Self -Examination to Melanoma Patients and Their Skin Check Partners

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 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.

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.

Eligibility: Inclusion Criteria:
  -  Personal history of Stage 0 (in situ) to IIB melanoma
  -  At least 6 weeks post-surgical treatment of Stage 0 (in situ) to IIB melanoma
  -  Age 18-70 years old
  -  Have sufficient vision to read a newspaper in order to visually detect changes of the skin
  -  Able to read English or Spanish at a sixth grade language level
  -  Have a skin check partner (i.e. spouse, family member, or friend) who is willing to participate in the research with the patient
  Exclusion Criteria:
  -  Subjects overburdened with other co-morbid diseases (e.g. chronic immunosuppression from organ transplantation) or medical treatments (e.g. chemotherapy)
  -  Subjects unable to participate in a conversation at a sixth grade language level due to cognitive impairment (e.g. by a stroke)
  -  For newly enrolled subjects only: Prior participation in skin self-examination research

Relevance to patient case: not relevant