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

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.

Study Overview

• Status: Completed
• Conditions: Melanoma
• Intervention / Treatment: Behavioral: Digital photographs loaded onto a mobile device; Behavioral: Skin exam reminders; Behavioral: Social support network

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Control; Patients use digital photographs loaded onto a mobile device	Behavioral: Digital photographs loaded onto a mobile device
EXPERIMENTAL: Reminders; Patients use digital photographs loaded onto a mobile device and receive skin exam reminders	Behavioral: Digital photographs loaded onto a mobile device; Behavioral: Skin exam reminders
EXPERIMENTAL: Social Support; Patients use digital photographs loaded onto a mobile device and a social support network	Behavioral: Digital photographs loaded onto a mobile device; Behavioral: Social support network
EXPERIMENTAL: Combined; Patients use digital photographs loaded onto a mobile device and a social support network and receive skin exam reminders	Behavioral: Digital photographs loaded onto a mobile device; Behavioral: Skin exam reminders; Behavioral: Social support network

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 16, 2015
• Primary Completion (ACTUAL): January 25, 2017
• Study Completion (ACTUAL): January 25, 2017

Study Registration Dates

• First Submitted: August 3, 2015
• First Submitted That Met QC Criteria: August 7, 2015
• First Posted (ESTIMATE): August 13, 2015

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2017
• Last Update Submitted That Met QC Criteria: May 1, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: 821426