Strategies to Promote Skin Health

Squamous Cell Carcinoma Clinical Trial

Official title:

Strategies to Promote Skin Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03237013
• Other study ID #: 2253101
• Status: Completed
• Phase: N/A
• Start date: February 18, 2016
• Est. completion date: January 14, 2017

Study information

• Verified date: April 2019
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: January 14, 2017
• Est. primary completion date: December 14, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Carcinoma, Squamous Cell
• Skin Cancer
• Skin Cancer Melanoma
• Skin Neoplasms
• Squamous Cell Carcinoma

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	San Diego State University	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View Citation

Hillhouse J, Stapleton J, Turrisi R. Association of frequent indoor UV tanning with seasonal affective disorder. Arch Dermatol. 2005 Nov;141(11):1465. — View 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. — View Citation

Ramos Díaz NS, Jiménez Jiménez Ó, 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Indoor Tanning Intentions	A free-response items measuring intentional indoor intentions in the next 30 days.	Post assessment & 1-month assessment
Primary	Outdoor Tanning Intentions	A free-response items measuring intentional outdoor intentions in the next 30 days.	Post Assessment & 1-month assessment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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