Strategies to Promote Skin Health

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.

Study Overview

• Status: Completed
• Conditions: Skin Cancer; Basal Cell Carcinoma; Squamous Cell Carcinoma; Skin Cancer Melanoma
• Intervention / Treatment: Behavioral: Facial Morphing Intervention; Behavioral: Mindfulness Intervention

Detailed Description

Indoor and outdoor tanning are two of the most common risk factors for developing skin cancer. Predictors of indoor and outdoor tanning including negative body image and negative affect. Thus, to subsequently prevent skin cancer, interventions should focus on appearance concerns and negative affect. To date, limited brief efficacious skin cancer preventions exist. One potential program (APRIL AGE) a facial morphing software program, has recently been evaluated as a potential prevention program of skin cancer. However, limited data exists on the long term benefits of this program. Additionally, brief mindfulness programs have been found to be efficacious in preventing other health risk behaviors (e.g., smoking, negative affect, eating behaviors). To the investigators' knowledge, these brief mindfulness interventions have yet to be applied in skin cancer prevention. Thus, the investigators sought to compare the relative efficacy of the facial morphing intervention and the mindfulness intervention vs. control condition (treatment as usual). It was hypothesized that both facial morphing and mindfulness would lead to reductions in tanning behavior compared to the TAU condition. The investigators also tested contrasts between the facial morphing and mindfulness conditions, however, no directional hypotheses could be generated, due to the dearth of prior data on these interventions in skin cancer prevention.

• Study Type: Interventional
• Enrollment (Actual): 219
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92182
      • San Diego State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Failure to meet any of the above mentioned inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control (Treatment as Usual only); 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.
Experimental: Treatment as Usual + Facial Morphing; 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; 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.; Other Names: Facial Morphing
Placebo Comparator: Treatment as Usual + Mindfulness; 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; 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; Other Names: Mindfulness

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appearance Attitudes to Tan	Participants completed the Appearance Reasons to Tan latent subscale of the Physical Appearance Reasons for Tanning Scale (PARTS; Cafri et al., 2006, 2008). This scale consists of three manifest subscales: General Attractiveness, Acne, and Body Shape. These 19 items were scored along a five-point scale: 1 (definitely disagree) to 5 (definitely agree), with a possible total score range of 19-95 (higher scores indicating greater agreement). Total scores are averaged to reflect the average agreement with attitudes which may motivate one to tan (higher average scores indicating greater agreement).	Post assessment & 1-month assessment
Appearance Reasons Not to Tan	Participants completed the Appearance Reasons Not to Tan latent subscale of the Physical Appearance Reasons for Tanning Scale (PARTS; Cafri et al., 2006, 2008). This scale consists of two manifest subscales: Skin Damage and Skin Aging. These 9 items were scored along a five-point scale 1 (definitely disagree) to 5 (definitely agree) with a possible total score range of 9-45 (higher scores indicating greater agreement). Total scores are averaged to reflect the average agreement with attitudes to not tan; (higher average scores indicating greater agreement).	Post assessment and 1-month assessment
State Body Satisfaction	State level body satisfaction was measured using the Body Image States Scale (BISS; Cash, Fleming, Alindogan, Steadman, & Whitehead, 2002). This six-item self-report instrument utilizes a nine-point scale (1 [extremely dissatisfied] to 9 [extremely satisfied]); possible total scores range 6-54; higher scores indicate greater satisfaction. This measure is scored by averaging all scores to these six items, with higher average scores indicating greater body satisfaction.	Post-assessment
Trait Body Satisfaction	Trait level body satisfaction was measured using the Multidimensional Body-Self Relations Questionnaire-Appearance Evaluation subscale (MSBRQ-AE; Brown, Cash, & Mikulka, 1990; Cash, 2000). This seven-item self-report subscale utilizes a five-point scale (1 [definitely disagree] to 5 [definitely agree]) with possible score range of 7-35. This measure was scored by averaging all scores to these seven items, with higher scores indicating greater body satisfaction.	1-month assessment
Appearance Orientation	Trait level appearance orientation satisfaction was measured using the Appearance Schemas Inventory-Revised Short Form (ASI-R; Cash, Melnyk, & Hrabosky, 2004). This twenty-item self-report instrument assesses cognitive and behavioral investment in one's physical appearance. This measure utilizes a five-point scale (1 [definitely disagree] to 5 [definitely agree]), with total scores ranging from 20-100; higher scores indicate greater appearance investment. This measure is scored by averaging all scores to these twenty items (higher scores indicating greater appearance investment).	1-month assessment
State Positive Affect	State positive affect was measured using the positive affect subscale of the Positive and Negative Affect Scale-Short Form (PANAS-SF; Thompson, 2007). This self-report subscale consists of five items of the full ten-item measure. This subscale utilizes a five-point Likert-type scale ranging from 1 (never) to 5 (always). This measure is scored by summing all scores to these five items (range 5-25), with higher scores indicating greater state positive affect. For the purposes of this project, participants' item scores to these five items were averaged.	Post assessment
State Negative Affect	State negative affect was measured using the negative affect subscale of the Positive and Negative Affect Scale-Short Form (PANAS-SF; Thompson, 2007). This self-report subscale consists of five items of the full ten-item measure. This subscale utilizes a five-point Likert-type scale ranging from 1 (never) to 5 (always). This measure is scored by summing all scores to these five items (range 5-25), with higher scores indicating greater state negative affect. For the purposes of this project, participants' item scores to these five items were averaged.	Post assessment
Depressive Symptoms	Participants completed the Depression Anxiety Stress Scales Short Version (DASS-21) as a marker of trait level negative affect (Henry & Crawford, 2005). This 21-item self-report measure consists of three seven-item subscales: depression, anxiety, and stress. Items are measured along a 4-point scale (0 [not at all like me] to 3 [applied to me very much, or most of the time]); higher scores denote increased symptoms. Total sum scores for this instrument ranges from 0-63; scores for the depressive symptom subscale range from 0-21.	1-month assessment
Anxiety Symptoms	Participants completed the Depression Anxiety Stress Scales Short Version (DASS-21) as a marker of trait level negative affect (Henry & Crawford, 2005). This 21-item self-report measure consists of three seven-item subscales: depression, anxiety, and stress. Items are measured along a 4-point scale (0 [not at all like me] to 3 [applied to me very much, or most of the time]); higher scores denote increased symptoms. Total sum scores for this instrument ranges from 0-63; scores for the anxiety symptom subscale range from 0-21.	1-month assessment
Stress	Participants completed the Depression Anxiety Stress Scales Short Version (DASS-21) as a marker of trait level negative affect (Henry & Crawford, 2005). This 21-item self-report measure consists of three seven-item subscales: depression, anxiety, and stress. Items are measured along a 4-point scale (0 [not at all like me] to 3 [applied to me very much, or most of the time]); higher scores denote increased symptoms. Total sum scores for this instrument ranges from 0-63; scores for the stress symptom subscale range from 0-21.	1-month assessment

Collaborators and Investigators

• Sponsor: San Diego State University
• Investigators: Principal Investigator: Aaron J Blashill, PhD, San Diego State University

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2016
• Primary Completion (Actual): December 14, 2016
• Study Completion (Actual): January 14, 2017

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: August 1, 2017
• First Posted (Actual): August 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: April 18, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Sunbathing; Indoor Tanning; Facial Morphing; Skin Cancer Risk
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Skin Neoplasms; Carcinoma, Basal Cell
• Other Study ID Numbers: 2253101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no IPD sharing plan at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No