Clinical trial NCT03237013: Strategies to Promote Skin Health
Official title: Strategies to Promote Skin Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Cancer
Skin Cancer Melanoma
Squamous Cell Carcinoma
Basal Cell Carcinoma
Keywords: Sunbathing
Indoor Tanning
Facial Morphing
Skin Cancer Risk
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Indoor Tanning Sessions in the Last 30 Days
timeFrame: 1-month assessment
measure: Number of Outdoor Tanning Sessions in the Last 30 Days
timeFrame: 1-month assessment
measure: Indoor Tanning Intentions
timeFrame: Post assessment & 1-month assessment
measure: Outdoor Tanning Intentions
timeFrame: Post Assessment & 1-month assessment
Secondary outcomes:
measure: Appearance Attitudes to Tan
timeFrame: Post assessment & 1-month assessment
measure: Appearance Reasons Not to Tan
timeFrame: Post assessment and 1-month assessment
measure: State Body Satisfaction
timeFrame: Post-assessment
measure: Trait Body Satisfaction
timeFrame: 1-month assessment
measure: Appearance Orientation
timeFrame: 1-month assessment
measure: State Positive Affect
timeFrame: Post assessment
measure: State Negative Affect
timeFrame: Post assessment
measure: Depressive Symptoms
timeFrame: 1-month assessment
measure: Anxiety Symptoms
timeFrame: 1-month assessment
measure: Stress
timeFrame: 1-month assessment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
affiliation: San Diego State University
name: Aaron J Blashill, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Rogojanski J, Vettese LC, Antony MM. Coping with cigarette cravings: Comparison of suppression versus mindfulness-based strategies. Mindfulness, 2(1): 14-26, 2011.
citation: 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.
citation: 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.