Melanoma
Conditions
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.
Interventions
BEHAVIORALDigital photographs loaded onto a mobile device
BEHAVIORALSkin exam reminders
BEHAVIORALSocial support network
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin self-examination rates | 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
| Measure | Time frame | Description |
|---|---|---|
| Melanoma thickness at detection | 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. |
| Office visit rates | 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. |
| Features important to a skin self-examination tool | 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. |
| Melanoma detection rates | 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. |
| Study/technology implementation | 6 months | Evaluate the study/technology implementation process using the implementation sciences RE-AIM framework to categorize and describe as follows: Reach 1. Number of skin exams 2. Number of first time skin exams 3. 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 1. Number and extent of changes to patient surveys 2. Number and extent of changes to educational/training materials 3. Number and percent of patients expressing interest in, or inquiring about the study 4. Time spent educating patients on how to conduct a skin self-examination 5. Time spent educating clinicians on the study Maintenance 1. Number and percent of repeat skin exams 2. Number and percent of patients abandoning a particular modality 3. Changes in RE-AIM measurements from one month to the next |
| Biopsy rates | 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. |
Countries
United States
Outcome results
None listed