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Completed

NCT Number: NCT02520622

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

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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital photographs loaded onto a mobile device

Behavioral

Skin exam reminders

Behavioral

Social support network

Behavioral

Primary outcomes

  1. 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.

Secondary outcomes

  1. Features important to a skin self-examination tool

    Time frame: 6 months

    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.

  2. Melanoma thickness at detection

    Time frame: 6 months

    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.

  3. Office visit rates

    Time frame: 6 months

    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.

  4. Biopsy rates

    Time frame: 6 months

    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.

  5. Melanoma detection rates

    Time frame: 6 months

    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. Study/technology implementation

    Time frame: 6 months

    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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 13, 2015
Registry last updated
May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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