Dermatology/Skin - OtherNCT03489356
Project Options - The ABC Method
A study testing Addressing Behavior Change (ABC) in people with Dermatology/Skin - Other and Health Behavior, run by Penn State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatology/Skin - Other, Health Behavior, Sunburn
- What is being tested?
- Addressing Behavior Change (ABC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2016to 21 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- scheduled for a skin exam with participating dermatologists
Who cannot join
- psoriasis
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Efficacy of a Behavioral Intervention to Reduce Skin Cancer Risk Among Patients
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.
- Conditions
- Dermatology/Skin - Other, Health Behavior, Sunburn
- Being tested
- Addressing Behavior Change (ABC)
- Keywords
- Addressing Behavior Change (ABC), Addressing Behavior Change (ABC) Intervention, Addressing Behavior Change (ABC) Intervention Method
- Medical subject headings
- Health Behavior, Sunburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Addressing Behavior Change (ABC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Addressing Behavior Change (ABC) intervention delivery method Receives: Behavioral: Addressing Behavior Change (ABC) |
| Control | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 1 month and 3 months follow-up
Secondary outcomes (1)
Sunburns
Number of sunburns reported by patients
Measured: Baseline, 1 month follow-up, 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start25 Apr 2016
- Primary completion21 Nov 2017
- Study completion21 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dermatology/Skin - OtherStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kimberly Mallett, Penn State University
- Investigators
- Kimberly A Mallett, Ph.D., Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489356
- Sponsor's protocol ID
- 182279
- Other IDs
- R21CA196924
- Status last verified
- Dec 2019
- First submitted
- 16 Mar 2018
- Last updated
- 4 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Behavioral Intervention to Reduce Skin Cancer Risk Among Patients
- ClinicalTrials.gov ID
- NCT03489356
- Acronym / sponsor ID
- 182279
- Conditions
- Dermatology/Skin - Other, Health Behavior, Sunburn
- Keywords
- Addressing Behavior Change (ABC), Addressing Behavior Change (ABC) Intervention, Addressing Behavior Change (ABC) Intervention Method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 25 Apr 2016 (actual)
- Primary completion
- 21 Nov 2017 (actual)
- Study completion
- 21 Nov 2017 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Addressing Behavior Change (ABC)Addressing Behavior Change (ABC) intervention delivery method |
| Control | No intervention | –Control |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- scheduled for a skin exam with participating dermatologists
Key exclusion criteria (1 listed)
- psoriasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention |
Primary outcome
Patient Behavior Changes
Time frame: 1 month and 3 months follow-up
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 secondary outcome
Sunburns
Time frame: Baseline, 1 month follow-up, 3 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Results publication: PubMed 30090918Mallett 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly A Mallett, Ph.D. principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Addressing Behavior Change (ABC) in people with Dermatology/Skin - Other and Health Behavior, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Behavior Changes (time frame: 1 month and 3 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03489356, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2019.