Project Options - The ABC Method

NCT ID: NCT03489356

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-25
• Study Completion Date: 2017-11-21

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.

Conditions

Dermatology/Skin - Other; Health Behavior; Sunburn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

Addressing Behavior Change (ABC) intervention delivery method

Group Type: EXPERIMENTAL

Addressing Behavior Change (ABC)

Intervention Type: 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.

Control

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Addressing 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• scheduled for a skin exam with participating dermatologists

Exclusion Criteria

• psoriasis

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Kimberly Mallett

Research Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kimberly A Mallett, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 30090918 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R21CA196924

Identifier Type: NIH

Identifier Source: secondary_id

View Link

182279

Identifier Type: -

Identifier Source: org_study_id