Skin CancerNCT03419637
Mobile Devices as Educational Skin History Tools
A study testing Mobile app in people with Skin Cancer, run by University of Pennsylvania at 1 site in United States.
Trial summary
Part I of this study surveys patients in the Penn Dermatologic Surgery Clinic to evaluate if a need exists for increased patient understanding of their skin history and which factors, if any, related to the patient or their skin history are associated with this need. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Mobile app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2017to 31 Dec 2018
- 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
- Have an appointment in the Penn Dermatologic Surgery Clinic for removal of a skin area during the study enrollment period
- Possession of a mobile device running iOS with the study mobile app (intervention) successfully installed (assistance will be provided by research staff if needed)
Who cannot join
- Children or adolescents, or if the patient is court-ordered to attend residential alcohol or other drug treatment facilities and therefore considered prisoners
- Patients will also be excluded if they are incompetent to provide informed consent and HIPAA authorization.
- If the area being operated on is of the genitals or breasts
- If the area being operated on is of the face, and photos of the area cannot be cropped or the eyes cannot be covered sufficiently such that photos are non-identifying
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Evaluating the Use of Mobile Devices as Educational Tools Regarding Skin History
Part I of this study surveys patients in the Penn Dermatologic Surgery Clinic to evaluate if a need exists for increased patient understanding of their skin history and which factors, if any, related to the patient or their skin history are associated with this need. In part II, the study aim is to evaluate mobile technology as a way of improving patient understanding of diagnoses, treatments, and procedures. In this part of the study, eligible patients from part I will be randomized either to a control group that receives the current standard of care regarding in-clinic counseling, informational handouts, and access to their medical records, or to an intervention group that in addition to the current standard of care, is setup with a mobile app, allowing patients to view a skin history summary report and a reference on their skin findings and procedures. Patients then complete a survey to establish their baseline understanding of their clinic visit. Three weeks later the patient is emailed a follow-up survey to assess their understanding of their in-clinic visit. Differences in understanding between the two study groups will be assessed by comparing the number of correctly answered survey items regarding their in-clinic visit, both at baseline (immediately following their surgery) and three weeks later. Qualitative information regarding satisfaction and areas of improvement will also be collected via survey. Patients who have an appointment during the study period at the Penn Dermatologic Surgery clinic for a skin excision will be eligible for inclusion.
- Conditions
- Skin Cancer
- Being tested
- Mobile app
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile appOther
The mobile app, or app, is installed on the patient's mobile device and is used to document the surgical procedure with before and after photographs, including pre- and post-surgery diagnosis. The app allows patients to view a skin history summary report and a reference on their skin findings and procedures.
| Study group | Role | What they receive |
|---|---|---|
| Control - Standard of Care | No intervention | The standard of care consists of in-clinic counseling, informational handouts, and access to patient medical records |
| Intervention - Mobile app | Experimental | The mobile app, or app, is used to document before and after photos of the excised skin areas and to document related diagnoses. The app allows patients to view a skin history summary report and a reference on their skin findings and procedures. Receives: Other: Mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding of recent skin excision - 3 weeks later
After study enrollment, patients have one or more skin areas excised. They complete an in-clinic survey immediately after the excision and another survey 3 weeks later where they are asked questions regarding the clinic visit and the related excised skin areas and diagnoses. Understanding is assessed by comparing against the medical record to calculate the number/percent of correct responses.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start4 Apr 2017
- Primary completion2 Aug 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Miller, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419637
- Sponsor's protocol ID
- 826558
- Status last verified
- Jun 2023
- First submitted
- 26 Jan 2018
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Mobile Devices as Educational Tools Regarding Skin History
- ClinicalTrials.gov ID
- NCT03419637
- Acronym / sponsor ID
- 826558
- Conditions
- Skin Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 2 Aug 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 5 Feb 2018 (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.
Part I of this study surveys patients in the Penn Dermatologic Surgery Clinic to evaluate if a need exists for increased patient understanding of their skin history and which factors, if any, related to the patient or their skin history are associated with this need. In part II, the study aim is to evaluate mobile technology as a way of improving patient understanding of diagnoses, treatments, and procedures. In this part of the study, eligible patients from part I will be randomized either to a control group that receives the current standard of care regarding in-clinic counseling, informational handouts, and access to their medical records, or to an intervention group that in addition to the current standard of care, is setup with a mobile app, allowing patients to view a skin history summary report and a reference on their skin findings and procedures. Patients then complete a survey to establish their baseline understanding of their clinic visit. Three weeks later the patient is emailed a follow-up survey to assess their understanding of their in-clinic visit. Differences in understanding between the two study groups will be assessed by comparing the number of correctly answered survey items regarding their in-clinic visit, both at baseline (immediately following their surgery) and three weeks later. Qualitative information regarding satisfaction and areas of improvement will also be collected via survey. Patients who have an appointment during the study period at the Penn Dermatologic Surgery clinic for a skin excision will be eligible for inclusion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control - Standard of Care | No intervention | –The standard of care consists of in-clinic counseling, informational handouts, and access to patient medical records |
| Intervention - Mobile app | Experimental | Other: Mobile appThe mobile app, or app, is used to document before and after photos of the excised skin areas and to document related diagnoses. The app allows patients to view a skin history summary report and a reference on their skin findings and procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have an appointment in the Penn Dermatologic Surgery Clinic for removal of a skin area during the study enrollment period
- Possession of a mobile device running iOS with the study mobile app (intervention) successfully installed (assistance will be provided by research staff if needed)
Key exclusion criteria (4 listed)
- Children or adolescents, or if the patient is court-ordered to attend residential alcohol or other drug treatment facilities and therefore considered prisoners
- Patients will also be excluded if they are incompetent to provide informed consent and HIPAA authorization.
- If the area being operated on is of the genitals or breasts
- If the area being operated on is of the face, and photos of the area cannot be cropped or the eyes cannot be covered sufficiently such that photos are non-identifying
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 |
|---|---|---|
| Mobile appThe mobile app, or app, is installed on the patient's mobile device and is used to document the surgical procedure with before and after photographs, including pre- and post-surgery diagnosis. The app allows patients to view a skin history summary report and a reference on their skin findings and procedures. | Other | Intervention - Mobile app |
Primary outcome
Understanding of recent skin excision - 3 weeks later
Time frame: 3 weeks
After study enrollment, patients have one or more skin areas excised. They complete an in-clinic survey immediately after the excision and another survey 3 weeks later where they are asked questions regarding the clinic visit and the related excised skin areas and diagnoses. Understanding is assessed by comparing against the medical record to calculate the number/percent of correct responses.
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 29 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Christopher Miller, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile app in people with Skin Cancer, 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 2 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: finished, as of the sponsor's last update on 29 Jun 2023. 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?
Understanding of recent skin excision - 3 weeks later (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2023.