CLINICAL PRACTICE GUIDELINE CU-014 Version 1

PREVENTION OF SKIN CANCER Effective Date: February, 2013

The recommendations contained in this guideline are a consensus of the Alberta Provincial Cutaneous Tumour Team based on a synthesis of currently accepted approaches to management, derived from a review of relevant scientific literature. Clinicians applying these guidelines should, in consultation with the patient, use independent medical judgment in the context of individual clinical circumstances to direct care.

CLINICAL PRACTICE GUIDELINE CU-014 Version 1

BACKGROUND Skin cancer is collectively the most frequently diagnosed type of cancer. 1 The most common types of skin cancer include basal cell carcinoma, squamous cell carcinoma, and melanoma. In 2012, an estimated 81,300 Canadians were diagnosed with non-melanoma skin cancer, with an estimated 320 deaths. 1 Nonmelanoma skin cancer is typically curable if not very advanced; 2 however, melanoma is one of the more devastating types of cancers. The 5-year survival rate for melanoma is 62% and 16% for regional and distant stage disease, respectively, as compared to 98% for localized disease. 2 Advanced stage melanoma often requires highly toxic immunotherapy or chemotherapy 3,4 and carries a higher risk than non-melanoma skin cancer of metastasizing to the liver, lungs, or brain. 5 The incidence of melanoma is increasing by about 1.4% per year; in 2012, an estimated 5,800 Canadians were diagnosed with melanoma, with an estimated 970 deaths. 1 In 2004, the total economic burden of skin cancer (melanoma and non-melanoma) was $532 million per year in direct ($66 million) and indirect ($466 million) costs. 6 The majority (83.4%) of these costs was attributable to melanoma. 6 By 2031, the total economic burden of skin cancer is expected to rise to $922 million per year. 6 These estimates do not account for the cost of newly available targeted drugs, such as vemurafenib or second-line ipilimumab, which cost $10,425 and $32,480, respectively, per patient per month. 7,8 The majority of both melanoma and non-melanoma skin cancers are attributable to exposure to ultraviolet (UV) radiation. 9 Non-melanoma skin cancers are found most often on the parts of the body exposed frequently to the sun (i.e., ears, face, neck and forearms), suggesting that long-term, repeated UV radiation exposure is a major causal factor. 9 Melanoma appears to be highest among those who have been exposed to intermittent high exposure to solar UV radiation; there is less evidence for the role of cumulative exposure, but given that the risk of melanoma is higher in those with a history of non-melanoma skin cancers and of solar keratoses (e.g., indicators of cumulative UV exposure), there may well be a strong role for cumulative UV exposure. 9 Since exposure to UV radiation is preventable, it may be possible to prevent non-melanoma and melanoma skin cancers by taking precautions to avoid exposure. The purpose of guideline is to: (1) provide family physicians with recommendations on how to counsel patients on the prevention of skin cancer; and (2) provide policy makers with recommendations on the efficacy of sun protection interventions and policies. GUIDELINE QUESTIONS 1. Who is most at risk and, therefore, most likely to benefit from sun protection strategies? 2. What counseling should healthcare providers offer to high-risk individuals regarding UV exposure? 3. What types of interventions are effective in limiting UV exposure to high-risk individuals? DEVELOPMENT This guideline was reviewed and endorsed by the Alberta Cutaneous Tumour Team. Members of the Alberta Cutaneous Tumour Team include surgeons, medical oncologists, radiation oncologists, dermatologists, pathologists, and nurses. Evidence was selected and reviewed by a working group comprised of members from the Alberta Cutaneous Tumour Team, content experts from the Health Protection Unit (Population and Public Health), and a Knowledge Management Specialist from the Guideline Utilization Resource Unit (CancerControl Alberta). A detailed description of the methodology used to develop the guideline can be found in the Guideline Utilization Resource Unit handbook.

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SEARCH STRATEGY The MEDLINE, PubMed, EMBASE, and CINAHL databases were searched for primary literature on skin cancer prevention. In addition, the following grey literature sources were also searched: Google Scholar, World Health Organization, OpenDOAR, OAISter, TRIP Database, Health Sciences Online, Health Canada, and Public Health Agency of Canada. The search strategy for literature on counseling in the primary care setting for patients regarding UV exposure included the search terms: primary care AND (counseling OR counselling) AND (UV exposure OR ultraviolet light exposure) AND (melanoma OR skin cancer); primary care AND (counseling OR counselling) AND (UV exposure OR ultraviolet light exposure) AND (risk* OR risk factor*). Publications included in this review were limited to systematic reviews and guidelines and totaled eight publications. The search strategy for literature on interventions for the general population included the search terms: (melanoma or skin cancer) AND (policy OR policies); (melanoma or skin cancer) AND (policy OR policies) AND prevent*; (melanoma or skin cancer) AND (policy OR policies) and sun protection. Non-English publications were excluded from the search; otherwise, any publications describing interventions intended to decrease UV exposure were included if they reported on outcomes related to UV exposure or rates of skin cancer. A total of 20 publications were included in the review. The search strategy for literature on interventions for specific high-risk groups included the search terms (counseling OR policy OR policies OR social marketing) AND (melanoma OR skin cancer) combined with each of the following: (1) (first-degree relative* OR hereditary); (2) (pediatric OR child*); (3) (outdoor worker* OR exposure OR occupational exposure); (4) (immunosuppressed OR immune deficien*); (5) (freckles OR lentigo); and (6) (indoor tanning OR tanning bed* OR tanning salon*). Non-English publications were excluded from the search; otherwise, any publications describing interventions intended to decrease UV exposure were included if they reported on outcomes related to UV exposure or rates of skin cancer. A total of 18 publications were included in the review. TARGET POPULATION The recommendations in this guideline apply to individuals at high risk of sustaining UV damage, leading to the development of skin cancer later in life. This includes individuals who meet any of the following criteria: o a personal history of melanoma or a first-degree relative who was diagnosed with melanoma; o a history of blistering or severe sunburns before adulthood or chronic exposure to UV light, either due to geographic location or due to the use of artificial tanning; o a skin type that is prone to burning (i.e., fair skin or skin that burns easily, rarely tans, red or blond hair, blue or light eyes, freckle easily); o a large number of moles, irregular moles, or large moles; o an occupation that requires work outdoors; and o a medical condition that makes them immunocompromised.

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RECOMMENDATIONS The Alberta Cutaneous Tumour Team endorses the strategies described in the Snapshot of Skin Cancer Prevention Facts and Figures: A Resource to Guide Skin Cancer Prevention in Alberta, 10 developed by the Health Protection Unit (Alberta Health Services, Population and Public Health). Described briefly is an adaptation of the key recommendations: 1. Counseling in the healthcare setting. The emphasis of counseling should be on children, adolescents, and young adults for whom there is the most evidence of success and who are at the highest risk of developing skin cancer (see Target Population) about minimizing exposure to UV radiation to reduce the risk of skin cancer. Current evidence is insufficient to recommend counseling adults older than age 24 years about minimizing UV radiation exposure to prevent skin cancer. Counseling should include the following: o Limit sun exposure.  Limit time in the midday sun (typically between 10am and 4pm) or when the sun is at its 11 highest.  Use shade wisely (when UV rays are the most intense), but remember that shade structures such as trees, umbrellas or canopies do not offer complete sun protection. Exposure to UV rays reflected on snow, water, and concrete should be avoided. o Wear protective clothing.  Wear a wide brim (>7.5 cm) hat to protect eyes, ears, face, and back of neck.  Use sunglasses that provide 99-100% UV-A/B protection to protect eyes.  Wear tightly woven, loose fitting clothes that cover as much of the body as possible; if possible, clothing with an ultraviolet protection factor (UPF) is optimal. o Use sunscreen and protective lip balm.  Use a broad spectrum sunscreen with an SPF of at least 30.  Apply liberally to ensure adequate protection; higher SPF sunscreens are best.  Reapply often: - every two hours or more often if swimming, toweling, or perspiring heavily - immediately after swimming, toweling, or heavy perspiration o Avoid indoor tanning (tanning beds and sun lamps). o Protect children and teens.  Babies younger than six months of age should be kept out of direct sunlight and protected from the sun using hats and protective clothing.  Children should be provided with sun protection for outdoor activities; use sunscreen on children six months of age or older.  Parents should counsel teens about the dangers of UV over-exposure and discourage them from using indoor tanning equipment.

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o Get vitamin D safely. Use vitamin D supplements and consume vitamin D fortified foods. Specifically, physicians and health care workers should not recommend tanning beds for Vitamin D supplementation. o Examine the skin. Regular examination of the skin will allow an individual to become familiar with his skin and become more likely to notice any changes. Changes to look for include an unusual lesion or a lesion that had changed. Prompt assessment and early referral to a dermatologist is recommended for suspicious pigmented lesions. 2.

3.

Population-based interventions that limit UV exposure. The literature suggests that the most effective interventions for reducing UV exposure are multifaceted and often have a follow-up component or multiple opportunities for interaction with participants. Therefore, combining these interventions may generate greater success than any one intervention can achieve alone. o Legislation to restrict the use of indoor tanning and to ban retail displays, advertising and promotion of indoor tanning. Legislation aimed at adolescents should consider both the stringency of the laws (i.e., parental consent versus age group ban for youth restrictions) and the enforcement of the laws (i.e., frequency of local inspections). o

Policies on the use of sun protection in high risk settings. School policies enforcing the use of sun protection are just one component of a larger community- wide, multi-component strategy to address sun exposure in children. There is limited evidence on the effectiveness of sun protection policies for outdoor workers.

o

Social marketing and mass media campaigns. Carefully planned campaigns designed to build public awareness of skin cancer and increase engagement from the community have been shown to change attitudes, beliefs, knowledge and behavior around UV exposure, with a trending decrease in skin cancer incidence.  Promotional efforts that utilize television advertising, radio, public service announcements, outdoor billboard advertising, transit advertising (bus sides), print advertisements, and the Internet can be considered.  Media campaigns involving an appearance-focused intervention such as UV photography that demonstrate cumulative skin damage in real time could be considered.

Education on sun protection. In the workplace setting, training and education for employees, as well as the provision of sun protection equipment may help to improve sun safety practices. Educational, curriculum-based programs in elementary schools that take place over several years have been shown to be effective.

DISCUSSION Included below is a brief summary of the most pertinent research articles (i.e., randomized controlled trials, where available, or the highest level of evidence available for a specific topic). For a complete summary of all articles included in the literature review, please see the Appendix on page 14. Counseling in the healthcare setting Primary care counseling can increase sun-protective behaviors and decrease indoor tanning based on randomized controlled trial data. 12 Dietrich AJ, et al. provided randomized data on the SunSafe intervention, in which practices were assisted with establishing an office system that promoted sun

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protection advice to children and parents during office visits. A total of 261 children and their parents were randomized to either the intervention group or a control group and then completed a survey, underwent observation, and underwent interviews. About half of respondents reported using sun protection 'most of the time' or 'almost always' during summer well care visits. Clinicians involved in the intervention increased their use of handouts, waiting room educational materials, and sunscreen samples. Sun protection advice was greater among parents randomized to the intervention, versus those randomized to the control group. 13 Another randomized trial by Norman GJ, et al. compared the use of patient assessment and counseling by a primary care physician, followed by several expert feedback reports, a brief printed manual, and periodic mailings with a control physician activity and nutrition intervention. The population was adolescents aged 11-15 years (n=819), who completed a composite questionnaire on sun protection behavior. Adoption of sun protection behavior was greater in intervention group over time, versus control group and at 24 months more adolescents in the intervention group reported avoiding the sun and limiting exposure during midday hours and using sunscreen with an SPF of at least 15. Furthermore, more adolescents in the intervention group had moved to the action or the maintenance stage of change than those in the control group. 14 Smaller cohort studies have also reported positive effects of physician advice and counseling on patients’ behaviors, especially regular sunscreen use, appropriate sunscreen application practices, and intermittent hat use. 15 Interventions targeted at both patients and providers may be useful. A 2006 survey among physicians in the U.S. found that the proportion of physicians actually providing counseling on the prevention of skin cancer to high risk patients was 67%. Specifically, 67% recommended sunscreen use, but only 13% counseled on other protective behaviors and only 7% discussed sunscreen types or procedures for effective use. Moreover, only 13% asked about changes in existing moles and none asked questions related to skin phototype or sun exposure habits. 16 The U.S. Preventative Services Task Force has recently (2012) 17 updated their guideline from 2003 18 on Behavioral Counseling to Prevent Skin Cancer. The recommendations now support counseling interventions for children, adolescents, and young adults aged 10 to 24 years with fair skin. They state that effective interventions are those that are generally of low intensity and are almost entirely accomplished within the primary care visit. They further state that successful counseling interventions use cancer prevention or appearance-focused messages (i.e., aging effect of ultraviolet radiation on the skin) to reach specific audiences. 17 This is in contrast to the 2003 recommendations that did not support routine counseling to prevent skin cancer. 18 Both the 2003 and 2012 reports do not recommend counseling for adults aged 24 years and older, as there is insufficient evidence. 17,18 Population-based interventions that limit ultraviolet (UV) exposure The most effective interventions for reducing UV exposure are multifaceted and often have a follow-up component or multiple opportunities for interaction with participants. Therefore, combining the following interventions may generate greater success than any one intervention can achieve alone. Legislation to restrict the use of indoor tanning In the United States, 33 of 50 states currently have at least some legislation regarding youth access to indoor tanning (i.e., youth ban, parental accompaniment, and/or parental consent). 19 In Australia, six states or territories have prohibited indoor tanning to all minors. 20 In Canada, Nova Scotia and Quebec have banned individuals less than 19 years of age and 18 years of age, respectively, from using tanning beds. 21 Similar legislation for youth under 18 years of age is being planned for British Columbia and

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Ontario; and in Manitoba written parental consent is required before individuals less than 18 years of age can use a tanning bed. 21 There is currently no Alberta legislation on the use of tanning beds. Despite the wide-spread adoption of indoor tanning legislation, studies evaluating legislation as an intervention are lacking. Epidemiologic data is premature, as legislation on indoor tanning has been introduced only recently in most jurisdictions. Nevertheless, the effectiveness of legislation for limiting UV radiation exposure among individuals at the highest risk of developing skin cancer cannot be ruled out. Among individuals aged 25 to 59 years who were diagnosed with invasive cutaneous melanoma in Minnesota (n=1,167), the rate of previous indoor tanning, as ascertained by survey, was 62.9%, versus 51.1% for age-matched controls (n=1,101) (adjusted OR 1.74; 95% CI 1.42-2.14). Risk also increased with use by years (p