Teaching Skin Self -Examination to Melanoma Patients and Their Skin Check Partners
Completed · Not applicable
Conditions studied: Melanoma
In brief
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.
Key facts
- Study ID
- NCT02854657
- Run by
- Northwestern University
- People needed
- 682
- Starts
- 2016-05-01
- Expected to finish
- 2021-03-09
- Last updated by the study team
- 2021-03-11
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Eligibility Criteria for amended portion of the study:
- Inclusion Criteria Melanoma survivors
- Ages 18-70, who are participating in the research supported by the R01
- Able to read English at a sixth-grade language level
- Willing to participate in daily online assessments
- Willingness to wear two sensors for 7 consecutive days
- Own a smartphone and able to use a mobile application
- Reliable access to the Internet
- Reliable mailing address for safe delivery and return of sensors
- Capable of walking a quarter of a mile (about 3 city blocks) with little to no difficulty
- Young adult relatives of melanoma survivors
- Ages 18-39 years old
- Able to read English at a sixth-grade language level
- Willing to participate in daily online assessments
- Willing to wear two sensors for 7 consecutive days
- Own a smartphone and able to use a mobile application
- Reliable access to the Internet
- Reliable mailing address for safe delivery and return of sensors
- Capable of walking a quarter of a mile (about 3 city blocks) with little to no difficulty
- Exclusion Criteria
- Excluded subjects are those 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) and have an ECOG performance status >1 will also be excluded.
Where it is running
- June K Robinson — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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