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

Primary Purpose

Melanoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital photographs loaded onto a mobile device
Skin exam reminders
Social support network
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Control

Reminders

Social Support

Combined

Arm Description

Patients use digital photographs loaded onto a mobile device

Patients use digital photographs loaded onto a mobile device and receive skin exam reminders

Patients use digital photographs loaded onto a mobile device and a social support network

Patients use digital photographs loaded onto a mobile device and a social support network and receive skin exam reminders

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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

Full Information

First Posted
August 3, 2015
Last Updated
May 1, 2017
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT02520622
Brief Title
Digital vs. Printed Photographs: Impact on Skin Self-Examinations
Official Title
Evaluation of the Impact of Using Digital Photographs on a Mobile Device Versus Printed Photographs on Patient Conducted Skin Exams
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 16, 2015 (Actual)
Primary Completion Date
January 25, 2017 (Actual)
Study Completion Date
January 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Description
Patients use digital photographs loaded onto a mobile device
Arm Title
Reminders
Arm Type
Experimental
Arm Description
Patients use digital photographs loaded onto a mobile device and receive skin exam reminders
Arm Title
Social Support
Arm Type
Experimental
Arm Description
Patients use digital photographs loaded onto a mobile device and a social support network
Arm Title
Combined
Arm Type
Experimental
Arm Description
Patients use digital photographs loaded onto a mobile device and a social support network and receive skin exam reminders
Intervention Type
Behavioral
Intervention Name(s)
Digital photographs loaded onto a mobile device
Intervention Type
Behavioral
Intervention Name(s)
Skin exam reminders
Intervention Type
Behavioral
Intervention Name(s)
Social support network
Primary Outcome Measure Information:
Title
Skin self-examination rates
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Features important to a skin self-examination tool
Description
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.
Time Frame
6 months
Title
Melanoma thickness at detection
Description
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.
Time Frame
6 months
Title
Office visit rates
Description
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.
Time Frame
6 months
Title
Biopsy rates
Description
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.
Time Frame
6 months
Title
Melanoma detection rates
Description
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.
Time Frame
6 months
Title
Study/technology implementation
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30062632
Citation
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.
Results Reference
derived

Learn more about this trial

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

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