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Project Options - The ABC Method

Primary Purpose

Dermatology/Skin - Other, Health Behavior, Sunburn

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Addressing Behavior Change (ABC)
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dermatology/Skin - Other focused on measuring Addressing Behavior Change (ABC), Addressing Behavior Change (ABC) Intervention, Addressing Behavior Change (ABC) Intervention Method

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • scheduled for a skin exam with participating dermatologists

Exclusion Criteria:

  • psoriasis

Sites / Locations

  • Penn State Health Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Addressing Behavior Change (ABC) intervention delivery method

Control

Outcomes

Primary Outcome Measures

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%

Secondary Outcome Measures

Sunburns
Number of sunburns reported by patients

Full Information

First Posted
March 16, 2018
Last Updated
December 2, 2019
Sponsor
Penn State University
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03489356
Brief Title
Project Options - The ABC Method
Official Title
Efficacy of a Behavioral Intervention to Reduce Skin Cancer Risk Among Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 25, 2016 (Actual)
Primary Completion Date
November 21, 2017 (Actual)
Study Completion Date
November 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatology/Skin - Other, Health Behavior, Sunburn
Keywords
Addressing Behavior Change (ABC), Addressing Behavior Change (ABC) Intervention, Addressing Behavior Change (ABC) Intervention Method

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Addressing Behavior Change (ABC) intervention delivery method
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control
Intervention Type
Behavioral
Intervention Name(s)
Addressing Behavior Change (ABC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Behavior Changes
Description
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 Outcome Measure Information:
Title
Sunburns
Description
Number of sunburns reported by patients
Time Frame
Baseline, 1 month follow-up, 3 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: scheduled for a skin exam with participating dermatologists Exclusion Criteria: psoriasis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly A Mallett, Ph.D.
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Health Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30090918
Citation
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.
Results Reference
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Project Options - The ABC Method

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