Clinical trial · Interventional
Teaching Skin Self-Examination to First-degree Relatives of Melanoma Patients Using Mobile App Technology
Validation of Mobile Technologies for Clinical Assessment, Monitoring, and Intervention (SBIR Topic 342, Direct to Phase II- Vignet, Inc.)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The company decided not to enroll subjects. The app was never developed.
Summary
Brief summary (as posted)
The proposed study builds upon the success of our research program (STU00017005: Interventions to teach melanoma patients skin self-examination and the continuation STU0201983) designed to increase early detection of melanomas before they metastasize. This study seeks to expand the use of our efficacious skin self-examination (SSE) training program to first-degree relatives with automated support with reminders and the dermatologist coaching about pictures of moles submitted by user. In 2015 there are more than 1 million living melanoma patients in the United States (US), and almost 500,000 were age 40-60 years. If each melanoma patient has 2.79 first-degree relatives (children, and siblings of melanoma patients), then there are 2.79 million first-degree relatives and 1 million melanoma patients or 3.79 million people at-risk to develop melanoma, who are predominantly non-Hispanic White. A first-degree relative (FDR) is the parent, sibling or child of a melanoma patient. In 2015, approximately 73,870 individuals in the US will be diagnosed with invasive melanoma and about 9,940 will die from the disease. People with a history of melanoma have 10 times greater risk of developing a second new melanoma relative to the general population. A first-degree relative of a melanoma patient (parent, child, sibling) has an 8 times greater chance of developing melanoma. Early detection with surgical excision at an early stage when treatment is usually more effective is the only proven curative strategy. Thus, enhanced surveillance for melanoma patients and screening for their first-degree relatives, who have the same skin type (skin that easily sunburns) and melanoma-risk habits (sunny vacations) as the melanoma survivor, has the potential to detect melanomas in the early stages where treatment prognosis is optimal. Indeed, several societies recommend routine screening by a physician for persons with a family history of melanoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eviderma Smart Phone Teledermatology Application (Eviderma) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Skin Self-Examination
- description
- Melanoma patients (n=300) and their first-degree relatives (n=300) that are between 16-70 years old will participate in the study. Participants will be randomized to receive the intervention or the control group. Participants randomized to the control group will have access to the app later. Assigned Interventions Behavioral: Skin self-examination structure training First-degree relatives download a mobile application onto their smart phone (n=150). This is the skin self-examination training intervention used in the original RCT (MoleScore). Participants will perform a Skin Self-Examination with partner assistance each month during the study. Participants will take a picture of one of their moles using their smart phone and upload to the application one image of a mole/freckle with a decision about their mole/freckle.
- interventionNames
- Other: Eviderma Smart Phone Teledermatology Application (Eviderma)
- type
- ACTIVE_COMPARATOR
- label
- Active Control
- description
- Participants (n=150) will complete web-based surveys at baseline and 4-months. Control participants do not initially receive training; however, after completing the 4-month survey they will be given access to the training. Assigned Interventions Behavioral: Skin self-examination structured training Training will be provided via a mobile application. After completing the 4-month survey, the control participants may request the link to download the application.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Inclusion Criteria for Melanoma Patient: * Melanoma patient with Stage 0-IIIA diagnosed within the last 5 years * At least 2 months post-surgical treatment * Age 18-70 years old * Has Internet access * Owns and can use a smartphone * Has an adult (18-70 years old) first-degree relative (sibling, parent, child) * Willing to recruit a first-degree relative to be educated in SSE * If the melanoma patient is selected to participate as a skin check partner by their first-degree relative, then they may serve as a skin check partner over the duration of the 4 months; however, no data is collected from skin check partners. Inclusion Criteria for First-degree Relative: * Have a first-degree relative who is melanoma patient with Stage 0-IIIA diagnosed within the last five years * No personal history of melanoma * Age 18-70 years old * Teen child 16 to 17 years of age. * Owns and can use a smartphone that can take close-up pictures of moles and can upload pictures of moles to the HIPPA secure website * Has Internet access * Willing to participate in two online assessments with an optional third survey if the person finds a clinically concerning mole and has an appointment with a primary care physician or a dermatologist to evaluate the clinically concerning mole, and receive reminders via the mobile device Exclusion Criteria: \- Exclusion Criteria for Melanoma Patient: • Subjects overburdened with other co-morbid diseases (e.g. chronic immunosuppression from organ transplantation) or medical treatments (e.g. chemotherapy) Exclusion Criteria for First-degree Relative: * Subjects overburdened with other co-morbid diseases (e.g. chronic immunosuppression from organ transplantation) or medical treatments (e.g. chemotherapy) * Do not own a smartphone
References
Publications (1)
- BACKGROUNDRobinson JK, Gaber R, Hultgren B, Eilers S, Blatt H, Stapleton J, Mallett K, Turrisi R, Duffecy J, Begale M, Martini M, Bilimoria K, Wayne J. Skin self-examination education for early detection of melanoma: a randomized controlled trial of Internet, workbook, and in-person interventions. J Med Internet Res. 2014 Jan 13;16(1):e7. doi: 10.2196/jmir.2883. PMID 24418949