Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Melanoma

Facies

Carcinoma, Basal Cell

Skin Neoplasms

Melanoma, Cutaneous Malignant

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neoplasms, Basal Cell

Neuroendocrine Tumor

Neuroepithelioma

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.

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.

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.

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.

Facial Morphing 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

Mindfulness Intervention

Aaron J Blashill, PhD

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.

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.

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.

Strategies to Promote Skin Health

There is no IPD sharing plan at this time.

One free-response item measuring intentional indoor frequency in the last 30 days

One free-response item measuring intentional outdoor frequency in the last 30 days

A free-response items measuring intentional indoor intentions in the next 30 days.

A free-response items measuring intentional outdoor intentions in the next 30 days.

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).

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).

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.

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.

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).

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.

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.

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.

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.

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.

San Diego State University

Assistant Professor

Adverse events were monitored/assessed, however, no adverse events occurred/were reported to study personnel. No adverse events to report.

Control (Treatment as Usual Only)

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.

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.

Treatment as Usual + Facial Morphing

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.

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, ph

Treatment as Usual + Mindfulness

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Participants were asked to self-report their skin type among six options representing a range of light to dark skin tones indicating greater burning and tanning characteristics using the Fitzpatrick Skin Type Scale (Fitzpatrick, 1988). Participants were provided with six skin types (i.e., Skin Type I: Very Fair--always burns cannot tan; Skin Type 2: Fair--usually burns sometimes tans; Skin Type 3: Medium--sometimes burns usually tans; Skin Type 4: Olive--rarely burns always tans; Skin Type 5: Brown--never burns always tans; and Skin Type 6: Black--never burns always tans) to self-select from.

Skin Type

Participants reported the number of sessions of indoor tanning they experienced in the past month

Indoor Tanning Frequency

Participants were asked to self-report the number of sessions of outdoor tanning they engaged in within the last month

Outdoor Tanning Frequency

Participants were asked to estimate the number of times they plan to indoor tan in the next month

Indoor Tanning Intentions

Participants were asked to estimate the number of times they plan to outdoor tan in the next month

Outdoor Tanning Intentions

Appearance Attitudes to Tan

Appearance Attitudes Not to Tan

State Body Satisfaction

Trait Body Satisfaction

Appearance Orientation

State Positive Affect

State Negative Affect

Depressive Symptoms

Anxiety Symptoms

Stress

Dr. Aaron Blashill

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.

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.

Number of Indoor Tanning Sessions in the Last 30 Days

Number of Outdoor Tanning Sessions in the Last 30 Days

Post-Assessment

1-Month Assessment

Post-assessment

Appearance Reasons Not to Tan

Baseline to Immediate Post-treatment

Immediate Post-treatment to 1-mo F/u

Behaviors and Mental Disorders

Postoperative Complications

Quality of Life

Jeremy Etzkorn, MD

The primary purpose of this study is to address the limited knowledge regarding patient well- being and nasal function after interpolated flap repair of post-Mohs surgical defects on the nose. Improved understanding of the patient experience will allow providers to better counsel their patients pre-operatively and potentially identify patients who may benefit from additional interventions.

This project is a multi-center prospective cohort study evaluating postoperative complication rates, quality of life outcomes, and nasal function after interpolated flap repair of post-Mohs surgical defects of the nose. Our primary outcome is the incidence of short-term complications(within 4 weeks of surgery) defined by the American College of Mohs Surgery as: death, bleeding requiring additional intervention, functional loss attributable to surgery, hospitalization for an operative complication, and surgical site infection. Secondary outcomes will include incidence of flap necrosis and evaluation of quality of life at 1, 4 and 16 weeks after repair. Quality of life will be investigated using the Skin Cancer Index (SCI)- a skin cancer specific quality of life instrument and the Nasal Appearance and Functional Evaluation Questionnaire (NAFEQ). Previous literature has demonstrated that Mohs surgery in the outpatient setting has a very low complication rate but this literature is generally limited to single-institution studies or studies examining smaller repairs. Furthermore, it has been proven that receiving a skin cancer diagnosis is stressful and patient satisfaction with skin cancer surgery is related to their appearance and scarring or changes in appearance can decrease quality of life. Our study serves to fill the current literature knowledge gaps by examining repair of large defects and looking at both complications and quality of life outcomes. Data collection will begin pre-operatively on patients 18 and older who require an interpolated flap repair of a post-Mohs surgical defect. These patients will then be followed and asked to complete SCI and NAFEQ surveys as well as complication questionnaires at prescribed intervals. All data will be stored via a secure RedCap database.

Interpolated Flap Study

Postoperative Complications, Nasal Function, and Quality of Life Following Interpolated Flap Repair for Post-Mohs Surgical Defects of the Nose: a Multi-center Prospective Observational Cohort Study

Short term (30 day) complications are defined by the American College of Mohs Surgery as death, bleeding requiring additional intervention, functional loss attributable to surgery, hospitalization for an operative outcome, and surgical site infection.

Skin Cancer Index is 15-item, disease specific, validated, quality of life instrument with three sub-scales, Emotion, Social, Appearance. A 5-point response format is used for each question where 1 equals "very much" and 5 equals "not at all". Standardized Scores Range from 0-100 with higher scores indicating higher quality of life. Standardized scores are obtained by summing the individual scores and dividing them by the number of items in each sub-scale.

The NAFEQ is a 14-item, validated quality of life instrument with two sections. The first seven items regard nasal function and airway passage, while the following seven questions assess satisfaction with nasal appearance. Responses are rated on a 5-point Likert scale where 1 equals "always" or "very dissatisfied", depending on the question, and 5 equals "never" or "very satisfied". Potential scores range from 7-35 with higher scores indicating greater satisfaction with overall nasal functioning and appearance.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Strategies to Promote Skin Health	NCT03237013	Skin Cancer Skin Cancer Mel... Squamous Cell C... Basal Cell Carc...	Facial Morphing... Mindfulness Int...	18 Years -	San Diego State University
Strategies to Promote Skin Health	NCT03237013	Skin Cancer Skin Cancer Mel... Squamous Cell C... Basal Cell Carc...	Facial Morphing... Mindfulness Int...	18 Years -	San Diego State University
Interpolated Flap Study	NCT04164550	Skin Cancer, No... Skin Cancer Mel... Mohs Micrograph...		18 Years -	University of Pennsylvania

Spots Global Cancer Trial Database for skin cancer melanoma