NCT03237013

Brief Summary

The purpose of the intended proposed research is to investigate and determine best strategies for preventing skin cancer for emerging adults. To answer this question, the investigators intended to pilot a randomized control trial with three arms: 1) Facial Morphing, 2) Mindfulness, and 3) Treatment as usual. The population from which the sample was drawn from was undergraduate psychology students from a large public university in Southern California, who report recent indoor/outdoor tanning, and intentions for future tanning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
219

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 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

February 18, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 2, 2017

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

July 5, 2019

Completed
Last Updated

July 5, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

July 26, 2017

Results QC Date

May 8, 2018

Last Update Submit

April 18, 2019

Conditions

Keywords

SunbathingIndoor TanningFacial MorphingSkin Cancer Risk

Outcome Measures

Primary Outcomes (4)

  • Number of Indoor Tanning Sessions in the Last 30 Days

    One free-response item measuring intentional indoor frequency in the last 30 days

    1-month assessment

  • Number of Outdoor Tanning Sessions in the Last 30 Days

    One free-response item measuring intentional outdoor frequency in the last 30 days

    1-month assessment

  • Indoor Tanning Intentions

    A free-response items measuring intentional indoor intentions in the next 30 days.

    Post assessment & 1-month assessment

  • Outdoor Tanning Intentions

    A free-response items measuring intentional outdoor intentions in the next 30 days.

    Post Assessment & 1-month assessment

Secondary Outcomes (10)

  • Appearance Attitudes to Tan

    Post assessment & 1-month assessment

  • Appearance Reasons Not to Tan

    Post assessment and 1-month assessment

  • State Body Satisfaction

    Post-assessment

  • Trait Body Satisfaction

    1-month assessment

  • Appearance Orientation

    1-month assessment

  • +5 more secondary outcomes

Study Arms (3)

Control (Treatment as Usual only)

NO INTERVENTION

Following baseline assessment, all participants were given health literature on tanning behavior from the U.S. Centers for Disease Control and Prevention (CDC). These materials included informational pamphlets addressing common myths regarding tanning behaviors, including "Tanned skin is not healthy skin", and "A base tan is not a safe tan. These misconceptions were accompanied by "burning truth", scientific data debunking these myths. Additionally, all participants received a packet on sun protective practices for oneself and family, which include skin cancer statistics and information on UV rays.

Treatment as Usual + Facial Morphing

EXPERIMENTAL

In addition to the health literature, participants completed the Facial Morphing Intervention. Participants had a digital photograph taken and uploaded to the APRIL® software, accompanied by information about their current age and self-identified race. Participants were presented with two, side-by-side identical 2D images of their face. Participants first viewed an image of their face from their current age, in two-year intervals, to age 72, the maximum age, with the "UV exposure" setting turned on. This process was repeated. Next, participants viewed the projected aging process, toggling the "UV exposure" setting (on and off), every ten year interval. The process was repeated using 3D images to view projected changes to their facial profiles.

Behavioral: Facial Morphing Intervention

Treatment as Usual + Mindfulness

PLACEBO COMPARATOR

In addition to the health literature, participants completed the Mindfulness Intervention. Participants listened to a 10-minute self-guided mindfulness audio exercise. The audio file is a scripted reading of an established, brief mindfulness exercise (Erisman \& Roemer, 2010). During this guided session, participants learned what mindfulness was, when it can be used, and benefits from practice. Listeners were led through steps, focusing on the physical sensations, breathing, and thoughts. After the exercise, participants were provided a handout highlighting key points about mindfulness and how to incorporate informal mindfulness practice into their daily life.

Behavioral: Mindfulness Intervention

Interventions

Participants assigned to this condition were exposed to facial morphing technology that displays the progression of facial-ageing up to 72years, both with and without damage from UV exposure.

Also known as: Facial Morphing
Treatment as Usual + Facial Morphing

Participants assigned to this condition engaged in a self-guided mindfulness intervention audio tape. This intervention instructed participants to pay attention to the present moment, with a non-judgemental stance. For example, participants were instructed to notice their breath, thoughts, feelings, physical sensations, and to internally describe them, without passing judgement

Also known as: Mindfulness
Treatment as Usual + Mindfulness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) aged 18 years old or older
  • \) enrolled as a student at the University
  • \) engaged in either indoor or outdoor tanning in the last 30 days
  • \) intended to tan (indoor or outdoor) in the last 30 days
  • \) English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego State University

San Diego, California, 92182, United States

Location

Related Publications (8)

  • Ashrafioun L, Bonar EE. Tanning addiction and psychopathology: Further evaluation of anxiety disorders and substance abuse. J Am Acad Dermatol. 2014 Mar;70(3):473-80. doi: 10.1016/j.jaad.2013.10.057. Epub 2013 Dec 25.

    PMID: 24373775BACKGROUND
  • Ramos Diaz NS, Jimenez Jimenez O, Lopes PN. The role of mindfulness in coping with recollections of acute stressors: a laboratory study. Psicothema. 2014;26(4):505-10. doi: 10.7334/psicothema2014.71.

    PMID: 25340898BACKGROUND
  • Erisman SM, Roemer L. A preliminary investigation of the effects of experimentally induced mindfulness on emotional responding to film clips. Emotion. 2010 Feb;10(1):72-82. doi: 10.1037/a0017162.

    PMID: 20141304BACKGROUND
  • Hillhouse J, Stapleton J, Turrisi R. Association of frequent indoor UV tanning with seasonal affective disorder. Arch Dermatol. 2005 Nov;141(11):1465. doi: 10.1001/archderm.141.11.1465. No abstract available.

    PMID: 16301398BACKGROUND
  • Marchiori D, Papies EK. A brief mindfulness intervention reduces unhealthy eating when hungry, but not the portion size effect. Appetite. 2014 Apr;75:40-5. doi: 10.1016/j.appet.2013.12.009. Epub 2013 Dec 20.

    PMID: 24361312BACKGROUND
  • Rogojanski J, Vettese LC, Antony MM. Coping with cigarette cravings: Comparison of suppression versus mindfulness-based strategies. Mindfulness, 2(1): 14-26, 2011.

    BACKGROUND
  • Williams AL, Grogan S, Buckley E, Clark-Carter D. Men's experiences of an appearance-focussed facial-ageing sun protection intervention: a qualitative study. Body Image. 2013 Mar;10(2):263-6. doi: 10.1016/j.bodyim.2013.01.003. Epub 2013 Feb 9.

    PMID: 23402802BACKGROUND
  • Blashill AJ, Rooney BM, Luberto CM, Gonzales M 4th, Grogan S. A brief facial morphing intervention to reduce skin cancer risk behaviors: Results from a randomized controlled trial. Body Image. 2018 Jun;25:177-185. doi: 10.1016/j.bodyim.2018.04.002.

MeSH Terms

Conditions

Skin NeoplasmsMelanomaCarcinoma, Squamous CellCarcinoma, Basal Cell

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Squamous CellNeoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr. Aaron Blashill
Organization
San Diego State University

Study Officials

  • Aaron J Blashill, PhD

    San Diego State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: At initial visit, participants were screened for study eligibility, consented, and randomized to a study condition. Participants first completed baseline assessment. Following, all participants completed intervention as determined by randomized assignment (i.e., control, facial morphing or mindfulness). At the initial visit, all subjects were assigned a subject ID number. Each subject ID was pre-assigned to a study condition, determined by an online randomization program, prior to recruitment. Each eligible participant had a 1/3 chance to be assigned to each of the three study conditions. Immediately after intervention, participants completed acute assessment, also consisting of self-report questionnaires. At the end of the initial visit, participants provided researchers a valid email address to be sent a subsequent follow-up survey. Approximately one month from the intervention date, participants received and completed the online follow-up survey.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 26, 2017

First Posted

August 2, 2017

Study Start

February 18, 2016

Primary Completion

December 14, 2016

Study Completion

January 14, 2017

Last Updated

July 5, 2019

Results First Posted

July 5, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

There is no IPD sharing plan at this time.

Locations