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CompletedNCT03489356Updated Dec 4, 2019

Project Options - The ABC Method

An interventional study of Addressing Behavior Change (ABC) in Dermatology/Skin - Other, Health Behavior and Sunburn, sponsored by Penn State University. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-04.

Sponsored by Penn State University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
186
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

Skin cancer is the most common malignancy in the U.S. and the incidence and mortality from skin cancer is on the rise. Individuals can decrease their risk of skin cancer by engaging in protective behaviors such as limiting intentional and unintentional UV exposure, and wearing broad-spectrum sunscreens and protective clothing. Despite knowing the risks and receiving dermatological care, many patients with and without a history of skin cancer frequently forget to use UV protection or fail to use it in an optimal manner to reduce their UV risk. To address these concerns, Mallett and colleagues developed a 3-minute brief ABC intervention - Addressing Behavior Change. The ABC intervention is designed to be delivered by dermatologists in the context of a routine office visit involving a skin examination. Previous work by Mallett and colleagues showed dermatologists were highly motivated to deliver the intervention, quickly learned the requisite skills, delivered the intervention with fidelity, and showed minimal decay in knowledge, motivation, and skills over a 6-month period. This study builds on a previous study by conducting an examination of the efficacy of the ABC intervention on patients' motivations and behaviors utilizing a prospective longitudinal design.

02

Conditions studied

  • Dermatology/Skin - Other
  • Health Behavior
  • Sunburn

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Keywords

  • Addressing Behavior Change (ABC)
  • Addressing Behavior Change (ABC) Intervention
  • Addressing Behavior Change (ABC) Intervention Method
03

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • scheduled for a skin exam with participating dermatologists

Exclusion criteria

Exclusion Criteria:

  • psoriasis
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
186 participants (actual)

Study arms

  • Experimental
    Intervention

    Addressing Behavior Change (ABC) intervention delivery method

    Behavioral: Addressing Behavior Change (ABC)

  • No intervention
    Control

    Control

Interventions

  • BehavioralAddressing Behavior Change (ABC)

    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.

05

What researchers measure

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%

    Time frame: 1 month and 3 months follow-up

Secondary outcomes

  1. Sunburns

    Number of sunburns reported by patients

    Time frame: Baseline, 1 month follow-up, 3 month follow-up

06

Study locations

1 site
  • Penn State Health Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
07

References and documents

Publications

  • 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. PubMed 30090918 ↗

Study documents

  • Protocol and statistical analysis plan · Jan 23, 2018

Documents are hosted by the registry — open the source record to download them.

08

Registry details

Key details

Study ID
NCT03489356
Lead sponsor
Penn State University
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
Responsible party
Kimberly Mallett (Research Associate Professor, Penn State University) — Principal investigator
First posted
Apr 5, 2018
Start date
Apr 25, 2016
Primary completion
Nov 21, 2017
Completion
Nov 21, 2017
Last update
Dec 4, 2019

Study contacts

Kimberly A Mallett, Ph.D.
principal investigator · Penn State University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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