Strategies to Promote Skin Health

NCT ID: NCT03237013

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 219 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-18
• Study Completion Date: 2017-01-14

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.

Conditions

Skin Cancer; Skin Cancer Melanoma; Squamous Cell Carcinoma; Basal Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Facial Morphing Intervention

Intervention Type: BEHAVIORAL

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.

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.

Group Type: PLACEBO_COMPARATOR

Mindfulness Intervention

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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

Intervention Type: BEHAVIORAL

Other Intervention Names

Facial Morphing; Mindfulness

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

San Diego State University

OTHER

Sponsor Role: lead

Responsible Party

Aaron Blashill

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aaron J Blashill, PhD

Role: PRINCIPAL_INVESTIGATOR

San Diego State University

Locations

San Diego State University

San Diego, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24373775 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25340898 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20141304 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16301398 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24361312 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 23402802 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29698824 (View on PubMed)

Other Identifiers

2253101

Identifier Type: -

Identifier Source: org_study_id