Strategies to Promote Skin Health

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Strategies to Promote Skin Health

Conditions
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Skin Cancer, Skin Cancer Melanoma, Squamous Cell Carcinoma, Basal Cell Carcinoma

Intervention / Treatment
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* Behavioral: Facial Morphing Intervention
* Behavioral: Mindfulness Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control (Treatment as Usual only)<br>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<br>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<br>* 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.<br>* Other names: Facial Morphing;|
| Placebo Comparator: Treatment as Usual + Mindfulness<br>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<br>* 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<br>* Other names: Mindfulness;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sunbathing, Indoor Tanning, Facial Morphing, Skin Cancer Risk