MelanomaNCT02520622
Digital vs. Printed Photographs: Impact on Skin Self-Examinations
A study testing Digital photographs loaded onto a mobile device, Skin exam reminders and Social support network in people with Melanoma, run by University of Pennsylvania at 1 site in United States.
Trial summary
The primary aim is to determine the impact of using digital photographs on a mobile device versus printed photographs on skin self-examination rates. The ease-of-use and overall satisfaction with the two exam modalities will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma
- What is being tested?
- Digital photographs loaded onto a mobile device, Skin exam reminders and Social support network
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2015to 25 Jan 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients presenting to the Penn Dermatology Pigmented Lesion Clinic who have a mobile device for personal use that either:
- (1) already have total body photography images, have a compact disc (CD) of digital versions of these images, and who do NOT already conduct proper monthly skin exams at home, and
- (2) patients that are having new images taken
Who cannot join
- Patients that are children or adolescents
- Patients that are court-ordered to attend residential alcohol or other drug treatment facilities and therefore considered prisoners
- Patients that are incompetent to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Evaluation of the Impact of Using Digital Photographs on a Mobile Device Versus Printed Photographs on Patient Conducted Skin Exams
The primary aim is to determine the impact of using digital photographs on a mobile device versus printed photographs on skin self-examination rates. The ease-of-use and overall satisfaction with the two exam modalities will be evaluated. Secondarily, the impact on melanoma thickness at detection, melanoma detection, biopsy, and office visit rates will be evaluated. The study involves patients in the Pigmented Lesion Clinic that have received total body photography for skin monitoring.
- Conditions
- Melanoma
- Being tested
- Digital photographs loaded onto a mobile device, Skin exam reminders, Social support network
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital photographs loaded onto a mobile deviceBehavioural
Skin exam remindersBehavioural
Social support networkBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Patients use digital photographs loaded onto a mobile device Receives: Behavioral: Digital photographs loaded onto a mobile device |
| Reminders | Experimental | Patients use digital photographs loaded onto a mobile device and receive skin exam reminders Receives: Behavioral: Digital photographs loaded onto a mobile device; Behavioral: Skin exam reminders |
| Social Support | Experimental | Patients use digital photographs loaded onto a mobile device and a social support network Receives: Behavioral: Digital photographs loaded onto a mobile device; Behavioral: Social support network |
| Combined | Experimental | Patients use digital photographs loaded onto a mobile device and a social support network and receive skin exam reminders Receives: Behavioral: Digital photographs loaded onto a mobile device; Behavioral: Skin exam reminders; Behavioral: Social support network |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin self-examination rates
Evaluate if printed photographs alone versus skin self-examinations supplemented with digital photos on a mobile device, or digital photos with reminders, social support networks, or both, lead to improved self-examination rates. This outcome is assessed by survey, before and after the intervention.
Measured: 6 months
Secondary outcomes (6)
Features important to a skin self-examination tool
Identify the features of digital or printed photograph use that are important to patients to have as part of a successful adjunct skin self-examination tool. This outcome is measured via survey after the intervention where participants rank on a Likert scale a series of features from critical to not important.
Measured: 6 months
Melanoma thickness at detection
Determine if using printed photographs alone versus skin self-examinations supplemented with digital photos on a mobile device leads to differing melanoma thickness upon detection. This outcome will be assessed at the group level using descriptive statistics to calculate a mean thickness between the two groups where a Student's t-test will be used to assess significance.
Measured: 6 months
Office visit rates
Determine if using printed photographs alone versus skin self-examinations supplemented with digital photos on a mobile device leads to differing office visit rates. This outcome will be assessed at the group level where the number of office visits over the course of the study will be compared for each group using a proportion's test or a chi-squared association test to assess if the rates between the two groups differ significantly.
Measured: 6 months
Biopsy rates
Determine if using printed photographs alone versus skin self-examinations supplemented with digital photos on a mobile device leads to differing biopsy rates. This outcome will be assessed at the group level where the number of biopsies over the course of the study will be compared for each group using a proportion's test or a chi-squared association test to assess if the rates between the two groups differ significantly.
Measured: 6 months
Melanoma detection rates
Determine if using printed photographs alone versus skin self-examinations supplemented with digital photos on a mobile device leads to differing melanoma detection rates. This outcome will be assessed at the group level where the number of new melanomas detected over the course of the study will be compared for each group using a proportion's test or a chi-squared association test to assess if the rates between the two groups differ significantly.
Measured: 6 months
Study/technology implementation
Evaluate the study/technology implementation process using the implementation sciences RE-AIM framework to categorize and describe as follows:
Reach
- Number of skin exams
- Number of first time skin exams
- Percent of patients offered/recommended full body photography
Effectiveness a. (Please see the primary outcome variables)
Adoption
- Percent opting for total body photography of whom it is offered/recommended
Implementation
- Number and extent of changes to patient surveys
- Number and extent of changes to educational/training materials
- Number and percent of patients expressing interest in, or inquiring about the study
- Time spent educating patients on how to conduct a skin self-examination
- Time spent educating clinicians on the study
Maintenance
- Number and percent of repeat skin exams
- Number and percent of patients abandoning a particular modality
- Changes in RE-AIM measurements from one month to the next
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study start16 Feb 2015
- Primary completion25 Jan 2017
- Study completion25 Jan 2017
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 University of PennsylvaniaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520622
- Sponsor's protocol ID
- 821426
- Status last verified
- May 2017
- First submitted
- 3 Aug 2015
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marek AJ, Chu EY, Ming ME, Khan ZA, Kovarik CL. Piloting the Use of Smartphones, Reminders, and Accountability Partners to Promote Skin Self-Examinations in Patients with Total Body Photography: A Randomized Controlled Trial. Am J Clin Dermatol. 2018 Oct;19(5):779-785. doi: 10.1007/s40257-018-0372-7.
PubMed 30062632
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Using Digital Photographs on a Mobile Device Versus Printed Photographs on Patient Conducted Skin Exams
- ClinicalTrials.gov ID
- NCT02520622
- Acronym / sponsor ID
- 821426
- Conditions
- Melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 16 Feb 2015 (actual)
- Primary completion
- 25 Jan 2017 (actual)
- Study completion
- 25 Jan 2017 (actual)
- First posted
- 13 Aug 2015 (estimated)
- 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 primary aim is to determine the impact of using digital photographs on a mobile device versus printed photographs on skin self-examination rates. The ease-of-use and overall satisfaction with the two exam modalities will be evaluated. Secondarily, the impact on melanoma thickness at detection, melanoma detection, biopsy, and office visit rates will be evaluated. The study involves patients in the Pigmented Lesion Clinic that have received total body photography for skin monitoring.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Behavioral: Digital photographs loaded onto a mobile devicePatients use digital photographs loaded onto a mobile device |
| Reminders | Experimental | Behavioral: Digital photographs loaded onto a mobile device, Behavioral: Skin exam remindersPatients use digital photographs loaded onto a mobile device and receive skin exam reminders |
| Social Support | Experimental | Behavioral: Digital photographs loaded onto a mobile device, Behavioral: Social support networkPatients use digital photographs loaded onto a mobile device and a social support network |
| Combined | Experimental | Behavioral: Digital photographs loaded onto a mobile device, Behavioral: Skin exam reminders, Behavioral: Social support networkPatients use digital photographs loaded onto a mobile device and a social support network and receive skin exam reminders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients presenting to the Penn Dermatology Pigmented Lesion Clinic who have a mobile device for personal use that either:
- (1) already have total body photography images, have a compact disc (CD) of digital versions of these images, and who do NOT already conduct proper monthly skin exams at home, and
- (2) patients that are having new images taken
Key exclusion criteria (3 listed)
- Patients that are children or adolescents
- Patients that are court-ordered to attend residential alcohol or other drug treatment facilities and therefore considered prisoners
- Patients that are incompetent to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
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 |
|---|---|---|
| Digital photographs loaded onto a mobile device | Behavioural | Combined, Control, Reminders, Social Support |
| Skin exam reminders | Behavioural | Combined, Reminders |
| Social support network | Behavioural | Combined, Social Support |
Primary outcome
Skin self-examination rates
Time frame: 6 months
Evaluate if printed photographs alone versus skin self-examinations supplemented with digital photos on a mobile device, or digital photos with reminders, social support networks, or both, lead to improved self-examination rates. This outcome is assessed by survey, before and after the intervention.
6 secondary outcomes
Features important to a skin self-examination tool
Time frame: 6 months
Melanoma thickness at detection
Time frame: 6 months
Office visit rates
Time frame: 6 months
Biopsy rates
Time frame: 6 months
Melanoma detection rates
Time frame: 6 months
Study/technology implementation
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Derived from this study: PubMed 30062632Marek AJ, Chu EY, Ming ME, Khan ZA, Kovarik CL. Piloting the Use of Smartphones, Reminders, and Accountability Partners to Promote Skin Self-Examinations in Patients with Total Body Photography: A Randomized Controlled Trial. Am J Clin Dermatol. 2018 Oct;19(5):779-785. doi: 10.1007/s40257-018-0372-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital photographs loaded onto a mobile device, Skin exam reminders and Social support network in people with Melanoma, run by University of Pennsylvania 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 2 May 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Skin self-examination rates (time frame: 6 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 NCT02520622, 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 2 May 2017.