Digital vs. Printed Photographs: Impact on Skin Self-Examinations

Melanoma Clinical Trial

Official title:

Evaluation of the Impact of Using Digital Photographs on a Mobile Device Versus Printed Photographs on Patient Conducted Skin Exams

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02520622
• Other study ID #: 821426
• Status: Completed
• Phase: N/A
• First received: August 3, 2015
• Last updated: May 1, 2017
• Start date: February 16, 2015
• Est. completion date: January 25, 2017

Study information

• Verified date: May 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: January 25, 2017
• Est. primary completion date: January 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Melanoma

Intervention

Behavioral:
• Digital photographs loaded onto a mobile device

• Skin exam reminders

• Social support network

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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; a. 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	6 months