Teaching Skin Self-Examination to First-degree Relatives of Melanoma Patients Using Mobile App Technology
| Status: | Withdrawn |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 16 - 70 |
| Updated: | 11/18/2018 |
| Start Date: | February 1, 2019 |
| End Date: | December 2019 |
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.
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.
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:
1. 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.
2. 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
3. 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.
4. 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
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:
1. 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.
2. 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
3. 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.
4. 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
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
We found this trial at
1
site
Chicago, Illinois 60611
Principal Investigator: June K. Robinson, MD
Phone: 312-503-5920
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