NCT02520622

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2017

Completed
Last Updated

May 2, 2017

Status Verified

May 1, 2017

Enrollment Period

1.9 years

First QC Date

August 3, 2015

Last Update Submit

May 1, 2017

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Features important to a skin self-examination tool

    6 months

  • Melanoma thickness at detection

    6 months

  • Office visit rates

    6 months

  • Biopsy rates

    6 months

  • Melanoma detection rates

    6 months

  • +1 more secondary outcomes

Study Arms (4)

Control

EXPERIMENTAL

Patients use digital photographs loaded onto a mobile device

Behavioral: Digital photographs loaded onto a mobile device

Reminders

EXPERIMENTAL

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

Behavioral: Digital photographs loaded onto a mobile deviceBehavioral: Skin exam reminders

Social Support

EXPERIMENTAL

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

Behavioral: Digital photographs loaded onto a mobile deviceBehavioral: Social support network

Combined

EXPERIMENTAL

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 deviceBehavioral: Skin exam remindersBehavioral: Social support network

Interventions

Digital photographs loaded onto a mobile deviceBEHAVIORAL
CombinedControlRemindersSocial Support
Skin exam remindersBEHAVIORAL
CombinedReminders
Social support networkBEHAVIORAL
CombinedSocial Support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 30062632DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 13, 2015

Study Start

February 16, 2015

Primary Completion

January 25, 2017

Study Completion

January 25, 2017

Last Updated

May 2, 2017

Record last verified: 2017-05

Locations

US(1)