Teaching Skin Self-Examination to First-degree Relatives of Melanoma Patients Using Mobile App Technology

NCT03177941 | Withdrawn DMC

• 1 other identifier: STU00204232
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Melanoma

Keywords

Melanoma; Skin Self-Examination; First-degree Relative; Mobile Application

Outcome Measures

Primary Outcomes (1)

• Performance of skin-self examination

  The first-degree relative and their skin check partner check about 5 moles/ freckles monthly, and upload a photograph of one mole with a decision about whether the mole is benign, needs to be watched for change, or may be malignant and they need to see a doctor.

  4-months

Secondary Outcomes (1)

• Engage a partner in helping to check hard to see locations.

  4-months

Study Arms (2)

Skin Self-Examination

EXPERIMENTAL

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.

Other: Eviderma Smart Phone Teledermatology Application (Eviderma)

Active Control

ACTIVE COMPARATOR

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.

Other: Eviderma Smart Phone Teledermatology Application (Eviderma)

Interventions

Eviderma Smart Phone Teledermatology Application (Eviderma) OTHER

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.

Active Control; Skin Self-Examination

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

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 overburdened with other co-morbid diseases (e.g. chronic immunosuppression from organ transplantation) or medical treatments (e.g. chemotherapy)
• Do not own a smartphone

Sponsors & Collaborators

• Northwestern University: lead
• Vibrent Health: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Northwestern University Feinberg School of Medicine Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Robinson 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 BACKGROUND

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• June K. Robinson, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: 2 Group Random Clinical Trial

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 6, 2017
• Study Start: February 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 16, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)