MelanomaNCT03177941
Teaching Skin Self-Examination to First-degree Relatives of Melanoma Patients Using Mobile App Technology
A study testing Eviderma Smart Phone Teledermatology Application (Eviderma) in people with Melanoma, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Melanoma
- What is being tested?
- Eviderma Smart Phone Teledermatology Application (Eviderma)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 15Show fewer
- 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
Who cannot join
- 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)
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: Validation of Mobile Technologies for Clinical Assessment, Monitoring, and Intervention (SBIR Topic 342, Direct to Phase II- Vignet, Inc.)
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.
Read the detailed description
The melanoma diagnosis represents a patchwork of transitions for the family with the opportunity to promote early detection in the first-degree relatives of melanoma patients. While family communication is a promising way to promote risk awareness and provide skills training in skin self-examination (SSE), knowing about a family member with a history of melanoma is no guarantee that a relative will accept their risk or act to minimize their risk by performing SSE. Indeed performance of SSE by people at-risk to develop melanoma ranges from 39% to 50%. Family separation by distance can now be overcome with technology (Skype, Facetime), but support for melanoma patients, who frame the risk of developing melanoma for their relatives, does not exist. The melanoma patient needs to be a) confident in their ability to communicate with at-risk relatives, b) able to reassure their loved one(s) that they can learn to do a skin check and perform it well, and c) supported in their decisions about pigmented lesions (moles) by ready access to a physician. The tools to learn how to check for melanoma with the assistance of a partner to see locations that are difficult for a person to see on their own body, e.g. the back and tops of the ears have been developed and validated by Robinson et al. Now, we will use of informatics technology of the proven physician-to-physician consultation of the Vibrent Mobile Telederm system to provide first-degree relatives of melanoma patients with education about their risk of developing melanoma and the importance of early detection, teach the skills to perform SSE, provide diaries for home use and access to a dermatologist. The first-degree relative will download the Eviderma Smart Phone Teledermatology Application (Eviderma), learn how to perform SSE, and self-report their adherence to their care plan by reporting their SSE results, and send the dermatologist a picture of one pigmented lesion (mole) each month with scores of the features and a decision about whether it is concerning, and the dermatologist will recommend next steps. The first-degree relative will benefit from automated self-service supported via tailored content and evidence-based health literacy and educational content. This program gives the first-degree relative of the melanoma patient the right information at the right time to learn the skills needed to detect concerning lesions without unnecessary visits to the doctor, thus, saving cost.
The study aims are as follows:
- To expand the uptake of an efficacious evidence-based SSE training program to first-degree relatives with the Eviderma program.
- Eviderma develops materials for the first-degree relatives of melanoma patients, and improves their education and awareness of the risk of developing melanoma.
- Assess engagement of first-degree relatives within the Eviderma program.
- To assess the efficacy of the Eviderma program for melanoma patients' first-degree relatives.
- A randomized controlled trial with the first-degree relatives of melanoma patients diagnosed with Stage 0-IIIA within the last five years
- Assess change from baseline to 4 months in: a) knowledge about melanoma b) perception of risk of developing melanoma and importance of early detection b) SSE skills c) SSE performance, d) physician visits
- To examine for whom the Eviderma program works best/least by assessing baseline perceived risk, importance of melanoma and its early detection, SSE self-efficacy and sex moderate SSE performance.
- Assess health care expenditures of first-degree relatives using the Eviderma program in comparison with controls for the cost of visits with the primary care physician and dermatologist, including biopsy of lesions and their pathology
- Conditions
- Melanoma
- Being tested
- Eviderma Smart Phone Teledermatology Application (Eviderma)
- Keywords
- Melanoma, Skin Self-Examination, First-degree Relative, Mobile Application
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Eviderma Smart Phone Teledermatology Application (Eviderma) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-months
Secondary outcomes (1)
Engage a partner in helping to check hard to see locations.
Self- reported responses to survey
Measured: 4-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start1 Feb 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: The company decided not to enroll subjects. The app was never developed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 Group Random Clinical Trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Vibrent Health, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, June Robinson, Northwestern University
- Investigators
- June K. Robinson, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177941
- Sponsor's protocol ID
- STU00204232
- Status last verified
- Nov 2018
- First submitted
- 2 Jun 2017
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publish results
Publications
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.
PubMed 24418949
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Mobile Technologies for Clinical Assessment, Monitoring, and Intervention (SBIR Topic 342, Direct to Phase II- Vignet, Inc.)
- ClinicalTrials.gov ID
- NCT03177941
- Acronym / sponsor ID
- STU00204232
- Conditions
- Melanoma
- Keywords
- Melanoma, Skin Self-Examination, First-degree Relative, Mobile Application
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The company decided not to enroll subjects. The app was never developed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Vibrent Health, National Institutes of Health (NIH)
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The melanoma diagnosis represents a patchwork of transitions for the family with the opportunity to promote early detection in the first-degree relatives of melanoma patients. While family communication is a promising way to promote risk awareness and provide skills training in skin self-examination (SSE), knowing about a family member with a history of melanoma is no guarantee that a relative will accept their risk or act to minimize their risk by performing SSE. Indeed performance of SSE by people at-risk to develop melanoma ranges from 39% to 50%. Family separation by distance can now be overcome with technology (Skype, Facetime), but support for melanoma patients, who frame the risk of developing melanoma for their relatives, does not exist. The melanoma patient needs to be a) confident in their ability to communicate with at-risk relatives, b) able to reassure their loved one(s) that they can learn to do a skin check and perform it well, and c) supported in their decisions about pigmented lesions (moles) by ready access to a physician. The tools to learn how to check for melanoma with the assistance of a partner to see locations that are difficult for a person to see on their own body, e.g. the back and tops of the ears have been developed and validated by Robinson et al. Now, we will use of informatics technology of the proven physician-to-physician consultation of the Vibrent Mobile Telederm system to provide first-degree relatives of melanoma patients with education about their risk of developing melanoma and the importance of early detection, teach the skills to perform SSE, provide diaries for home use and access to a dermatologist. The first-degree relative will download the Eviderma Smart Phone Teledermatology Application (Eviderma), learn how to perform SSE, and self-report their adherence to their care plan by reporting their SSE results, and send the dermatologist a picture of one pigmented lesion (mole) each month with scores of the features and a decision about whether it is concerning, and the dermatologist will recommend next steps. The first-degree relative will benefit from automated self-service supported via tailored content and evidence-based health literacy and educational content. This program gives the first-degree relative of the melanoma patient the right information at the right time to learn the skills needed to detect concerning lesions without unnecessary visits to the doctor, thus, saving cost.
The study aims are as follows:
- To expand the uptake of an efficacious evidence-based SSE training program to first-degree relatives with the Eviderma program.
- Eviderma develops materials for the first-degree relatives of melanoma patients, and improves their education and awareness of the risk of developing melanoma.
- Assess engagement of first-degree relatives within the Eviderma program.
- To assess the efficacy of the Eviderma program for melanoma patients' first-degree relatives.
- A randomized controlled trial with the first-degree relatives of melanoma patients diagnosed with Stage 0-IIIA within the last five years
- Assess change from baseline to 4 months in: a) knowledge about melanoma b) perception of risk of developing melanoma and importance of early detection b) SSE skills c) SSE performance, d) physician visits
- To examine for whom the Eviderma program works best/least by assessing baseline perceived risk, importance of melanoma and its early detection, SSE self-efficacy and sex moderate SSE performance.
- Assess health care expenditures of first-degree relatives using the Eviderma program in comparison with controls for the cost of visits with the primary care physician and dermatologist, including biopsy of lesions and their pathology
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 2 Group Random Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Skin Self-Examination | Experimental | Other: Eviderma Smart Phone Teledermatology Application (Eviderma)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. |
| Active Control | Active comparator | Other: Eviderma Smart Phone Teledermatology Application (Eviderma)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. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eviderma Smart Phone Teledermatology Application (Eviderma)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 | Active Control, Skin Self-Examination |
Primary outcome
Performance of skin-self examination
Time frame: 4-months
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.
1 secondary outcome
Engage a partner in helping to check hard to see locations.
Time frame: 4-months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Background: PubMed 24418949Robinson 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.
- Individual participant dataSharing planned: Yes. Publish results
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
June K. Robinson, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eviderma Smart Phone Teledermatology Application (Eviderma) in people with Melanoma, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of skin-self examination (time frame: 4-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03177941, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.