NCT03489356

Brief Summary

The present study explores the ability of dermatologists to influence patients' behavior using a novel and brief (3 minute) behavioral intervention in the context of naturally occurring patient interactions and shows promise for long term sustainability. The incidence of invasive skin cancers, cutaneous melanoma in particular, has nearly tripled in the U.S. between 1975 and 2004, making it the fastest rising incidence rate for all cancers in the United States. Dermatologists are in an ideal position to effect change in their patients. The present study will assess whether a brief intervention (The ABC-Addressing Behavior Change method) delivered to patients by dermatologists during a skin examination will increase the use of sun protection and reduce risk behaviors compared to patients who receive treatment as usual.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

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

April 25, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
Last Updated

December 4, 2019

Status Verified

December 1, 2019

Enrollment Period

1.6 years

First QC Date

March 16, 2018

Last Update Submit

December 2, 2019

Conditions

Dermatology/Skin - OtherHealth BehaviorSunburn

Keywords

Addressing Behavior Change (ABC)Addressing Behavior Change (ABC) InterventionAddressing Behavior Change (ABC) Intervention Method

Outcome Measures

Primary Outcomes (1)

  • Patient Behavior Changes

    Examine changes in patients' protective behaviors through surveys; Patients asked for the percent of time they use sunscreen on face, use sunscreen on body, reapply sunscreen often, and cover their skin; Response options range from (0) 0% to (5) 100%

    1 month and 3 months follow-up

Secondary Outcomes (1)

  • Sunburns

    Baseline, 1 month follow-up, 3 month follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

Addressing Behavior Change (ABC) intervention delivery method

Behavioral: Addressing Behavior Change (ABC)

Control

NO INTERVENTION

Control

Interventions

Addressing Behavior Change (ABC)BEHAVIORAL

The ABC is a 3-minute brief, dermatologist delivered intervention for dermatological patients that takes place during a skin examination. During the ABC intervention, dermatologists specifically assess patients' UV risk behaviors, discuss patients' motivation to use UV protection, and explore solutions to patient-reported barriers interfering with effective sunscreen use. Based on our previous research, the ABC intervention does not add additional time to the visit, but rather replaces treatment as usual conversations about sun protection.

Intervention

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • scheduled for a skin exam with participating dermatologists

You may not qualify if:

  • psoriasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

  • Mallett KA, Turrisi R, Billingsley E, Trager B, Ackerman S, Reavy R, Robinson JK. Evaluation of a Brief Dermatologist-Delivered Intervention vs Usual Care on Sun Protection Behavior. JAMA Dermatol. 2018 Sep 1;154(9):1010-1016. doi: 10.1001/jamadermatol.2018.2331.

    PMID: 30090918RESULT

MeSH Terms

Conditions

Health BehaviorSunburn

Condition Hierarchy (Ancestors)

BehaviorPhotosensitivity DisordersSkin DiseasesSkin and Connective Tissue DiseasesBurnsWounds and Injuries

Study Officials

  • Kimberly A Mallett, Ph.D.

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

March 16, 2018

First Posted

April 5, 2018

Study Start

April 25, 2016

Primary Completion

November 21, 2017

Study Completion

November 21, 2017

Last Updated

December 4, 2019

Record last verified: 2019-12

Locations

US(1)