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IMPROVING MEASUREMENTS OF QUALITY OF LIFE IN SKIN CANCER PATIENTS: Identifying Benchmarks for the Skin Cancer Index Kimberly Shao, B.S. Lynne Taylor, M.S., Ph.D. Thuzar Shin, M.D., Ph.D. Jeremy Etzkorn, M.D. Chris Miller, M.D. Joseph Sobanko, M.D. No financial disclosures INTRODUCTION Clinical research fellow Division of Dermatologic Surgery and Cutaneous Oncology (Perelman Center for Advanced Medicine) University of Pennsylvania INTRODUCTION Primary Investigator: Dr. Joseph Sobanko Assistant Professor and Director of Dermatologic Surgery Education at the Hospital of the University of Pennsylvania Founding member of iMPROVeD (Measurement of PRiority Outcome Variables in Dermatologic surgery) SKIN CANCER: EPIDEMIOLOGY Worldwide, nonmelanoma skin cancer (NMSC) is the most common cancer affecting white-skinned individuals, and the incidence is increasing In the US, 3.3 million persons were treated for at least 1 skin cancer in 2012 HOW DO WE MEASURE OUTCOMES? Mortality 3,500,000 75% from 3,000,000 2,500,000 2,000,000 Incidence Mortality 1,500,000 1,000,000 500,000 0 Per Year in the US for all Skin Cancers https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6421a6.htm melanomas Less utility when applied to skin cancer treatments HOW DO WE MEASURE OUTCOMES? Survival Rates Basal cell (BCC) and squamous cell carcinomas (SCC) are highly curable if detected early and treated Five-year survival for melanoma detected and treated before spread to the lymph nodes is 98% HOW DO WE MEASURE OUTCOMES? Recurrence 5-year tumor recurrence for all procedural treatments is low HOW DO WE MEASURE OUTCOMES? Adverse Events Minimal risk of major complications Studies show <1%-3% minor adverse events WHY DOES SKIN CANCER MATTER? WHAT ELSE CAN WE USE? Patient-reported outcomes (PROs) Satisfaction Scar Appearance Quality of Life Societal interactions Emotional Health Psychosocial Distress WHAT DO WE KNOW? Some earlier studies showed skin cancer had minimal effects on QOL However, most of the QOL instruments were validated in other dermatologic conditions WHAT DO WE (NOW) KNOW? Approximately 20-25% of skin cancer patients have reported elevated levels of anxiety or symptoms of depression Studies have also shown diminished quality of life (QOL) following a diagnosis of skin cancer HOW SHOULD WE MEASURE PROS? Disease-specific instruments European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Melanoma module (EORTC QLQ-M) Functional Assessment of Cancer Therapy – Melanoma (FACT-M) HOW SHOULD WE MEASURE PROS? Disease-specific instruments Skin Cancer Quality of Life Impact Tool (SCQOLIT) Skin Cancer Quality of Life Questionnaire (SCQOL) HOW ARE WE MEASURING PROS? Skin Cancer Index (SCI) Validated, patient-reported instrument developed to measure QOL in skin cancer patients Scale: 0-100 with higher values indicating increased QOL 15 questions split into 3 subscales: 1) Emotions 2) Societal interactions 3) Appearance-related concerns SCI During the past month, how much have you… 1. Worried that your skin cancer will spread to another part of your body? 2. Felt anxious about your skin cancer? 3. Worried that family members may also develop skin cancer? 4. Worried about the cause of skin cancer? 5. Felt frustrated about your skin cancer? 6. Worried that your tumor may become a more serious type of skin cancer? 7. Worried about new skin cancers occurring in the future? 8. Felt uncomfortable when meeting new people? 9. Felt concerned that your skin cancer may worry friends or family? 10. Worried about the length of time before you can go out in the public? 11. Felt bothered by people’s questions related to your skin cancer? 12. Felt embarrassed by your skin cancer? 13. Worried about how large the scar will be? 14. Thought about how skin cancer affects your attractiveness? 15. Thought about how noticeable the scar will be to others? Very Much Quite Moderately A a Bit Little Bit Not at All SCI: BENEFITS SCI is a relatively quick instrument. Generalized instruments may not capture QOL issues that are most relevant to patients with skin cancer. Especially true for appearance! As a majority of skin cancers are located on the head and neck, skin cancer and its treatments involve highly visible areas. SCI: LIMITATIONS No validated benchmarks for normal scores No established clinical correlates IN COMPARISON… HOSPITAL ANXIETY AND DEPRESSION SCALE (HADS) Validated, self-reported instrument Designed to measure anxiety and depression in non- psychiatric-hospital patients* 14 questions 7 anxiety 7 depression HOSPITAL ANXIETY AND DEPRESSION SCALE (HADS) Scale: 0-21, with higher values indicating increased suspicion for clinical anxiety or depression Has established cut-offs: 0-7: Normal 8-10: Borderline case 11-21: Probable clinical anxiety or depression OBJECTIVE Identify the relationship between the SCI and the HADS Establish clinically meaningful cut-off scores for the SCI METHODS Cross-sectional study Enrollment: February 1st, 2015-April 1st, 2015 PARTICIPANTS Inclusion criteria: 18 or older Biopsy-proven skin cancer Treated at the Division of Dermatologic Surgery at the Perelman Center for Advanced Medicine or Buck’s County Exclusion criteria: Nodal or distant metastases High grade melanoma PROTOCOL Immediately prior to surgery, patients were asked to provide and complete: Demographics 2. Health information 3. SCI 4. HADS 1. STATISTICAL ANALYSIS Summary statistics were calculated from sociodemographic and health survey questions Missing data from unanswered questions in the SCI or HADS were imputed using means from the same individual’s subscale scores STATISTICAL ANALYSIS SCI and HADS scores (and each of their subscales) were correlated via linear regression ROC curve analysis was performed to determine cut-off point for the SCI Logistic regressions were conducted for dichotomous outcomes and to estimate relative risk ratios TABLE 1A: DEMOGRAPHICS Total: n = 134 62% males Average age: 65.4 years All Caucasian Range of educational levels, income levels, employment statuses TABLE 1B: MEDICAL CHARACTERISTICS 16% were immunosuppressed Majority were healthy or had mild systemic disease (e.g. obesity, well-controlled DM/HTN, mild lung disease) 70% with prior history of skin cancer TABLE 1B: MEDICAL CHARACTERISTICS Medical Characteristics Current diagnosis (n = 130) Basal cell carcinoma Squamous cell carcinoma Melanoma Other Anatomic location (n = 134) Scalp Face Neck Back Chest Upper extremity Lower extremity N (%) 59 (45) 62 (48) 7 (5) 2 (2) 17 (13) 92 (69) 4 (3) 3 (2) 2 (1) 7 (5) 9 (7) TABLE 2A: SCI TOTAL SCORES Demographic Characteristics Average Metric Score Age (n=115) 40-60 60-80 > 80 Income (n=126) > 150K Employment (n = 131) Homemaker Self-employed Mean 69.8 SCI Total 95% CI p-value (66.3, 73.4) <0.001 60.1 74.8 79.3 (53.6, 66.6) (69.8, 79.7) (68.3, 90.3) 0.011 60.4 (53.3, 67.5) 0.002 51.6 51.0 (36.0, 67.3) (35.4, 66.7) TABLE 2B: SCI EMOTION SUBSCALE Demographic Characteristics Average Metric Score Income (n = 126) > 150K Employment (n = 131) Homemaker Self-employed SCI Emotion Mean 95% CI p-value 59.2 (54.9, 63.4) 0.010 46.4 (37.7, 55.1) 0.004 35.1 33.3 (15.9, 54.4) (14.1, 52.6) TABLE 2C: SCI SOCIAL SUBSCALE Demographic Characteristics Average Metric Score Age (n=115) 40-60 60-80 > 80 SCI Social Mean 95% CI 79.8 pvalue (76.5, 83.2) 0.027 74.3 82.9 89.4 (68.0, 80.6) (78.1, 87.6) (78.8, 100.0) TABLE 2D: SCI APPEARANCE SUBSCALE Demographic Characteristics Average Metric Score Gender (n=128) Male Female Age (n=115) 40-60 60-80 > 80 Income (n = 126) > 150K Employment (n = 131) Homemaker Self-employed SCI Appearance Mean 95% CI p-value 70.5 (65.8, 75.2) 0.015 75.6 63.4 (69.6, 81.7) (55.6, 71.2) < 0.001 55.0 78.6 84.5 (46.4, 63.5) (72.1, 85.0) (70.0, 98.9) 0.006 57.3 (47.9, 66.8) 0.001 46.9 54.2 (26.1, 67.6) (33.4, 74.9) TABLE 3: HADS- ANXIETY SCORES Demographic Characteristics Average Metric Score Age (n=115) 40-60 60-80 > 80 Employment (n = 131) Homemaker Self-employed HADS-Anxiety Mean 95% CI p-value 5.0 (4.5, 5.6) 0.006 6.2 4.1 4.9 (5.2, 7.2) (3.3, 4.9) (3.2, 6.6) 0.004 7.7 7.5 (5.2, 10.2) (5.0, 10.0) TABLE 3: HADS-DEPRESSION SCORES Demographic Characteristics Average Metric Score Income (n = 126) < 25K HADS-Depression Mean 95% CI p-value 2.9 (2.4, 3.3) 0.036 4.5 (2.8, 6.2) TABLE 3: HADS-DEPRESSION SCORES Medical Characteristics Average Metric Score Immune status (n = 131) Immunosuppressed ASA Health Status (n = 130) Life-threatening systemic disease Anatomic location (n = 134) Scalp Face Neck Back Chest Upper extremity Lower extremity HADS-Depression Mean 95% CI p-value 2.9 (2.4, 3.3) < 0.001 5.1 (3.9, 6.2) 0.008 8.0 (4.3, 11.7) 0.018 2.5 (1.2, 3.7) 2.6 (2.0, 3.1) 3.3 (0.7, 5.8) 6.7 (3.8, 9.6) 4.0 (0.4, 7.6) 5.4 (3.5, 7.3) 2.6 (0.9, 4.2) FIGURE I: SCATTERPLOT OF HADS-ANXIETY AND SCI TOTAL SCORE r = - 0.39, p<0.001 FIGURE 2: SCATTERPLOT OF HADSDEPRESSION AND SCI TOTAL SCORE r = - 0.045, p = 0.6079 FIGURE 3: ROC CURVE FOR SCI TOTAL SCORE AS A PREDICTOR OF HADSANXIETY ≥8 • Area under curve (AUC) = 0.6821 (p=0.003, 95% CI 0.5750-0.7892) • For SCI Total Score of ≤78, sensitivity is 84.4% (specificity 48.0%) TABLE 4: RELATIVE RISK RATIO FOR FOR SCI TOTAL SCORE OF ≤78 AS A PREDICTOR OF HADS-ANXIETY ≥8 Measure Risk 95% CI SCI > 78 0.09 0.03-0.20 SCI ≤ 78 0.34 0.24-0.45 Relative Risk 3.65 1.50-8.87 p-value 0.004 DISCUSSION Young age, female gender, higher income, and lack of full- or part-time employment were associated with reduced QOL In regards to appearance, women were 2x more likely to report reduced QOL Facial location of skin cancer magnified the disparities DISCUSSION SCI has a statistically significant moderate inverse linear relationship with HADS-Anxiety score In the ROC Curve analysis for a HADS-Anxiety cut-off of ≥8/21 AUC was >0.50 Indicates SCI’s predictive ability to discriminate those with a HADS anxiety subscale score of ≥8 from normal subjects DISCUSSION Cut-off score for SCI of ≤78 showed a sensitivity of 84.4% SCI of ≤78 showed nearly 4x greater risk of having a HADS Anxiety score of ≥8 CONCLUSION & SIGNIFICANCE The Skin Cancer Index (SCI) can be used as a single- instrument screening tool for clinical anxiety. This allows physicians to identify and risk-stratify those patients who are more likely to have psychosocial distress. WHY NOT JUST USE THE HADS? SCI provides disease-specific information about the impact of skin cancer on factors such as emotional health, societal interactions, and appearance-related concerns. Can be used to measure concerns in patients receiving surgical treatment FUTURE DIRECTIONS We plan to either develop interventions or improve peri- operative counseling to help those at risk for clinical anxiety Using the subscales of the SCI, may even be able to narrow a foci for interventions (e.g. appearance-related concerns) ACKNOWLEDGMENTS PI and mentor: Dr. Sobanko Statistical assistance: Dr. Taylor Co-authors: Dr. Shin, Dr. Etzkorn, Dr. Miller Chair of the Department of Dermatology: Dr. George Cotsarelis University of Pennsylvania REFERENCES 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. Rogers HW, Weinstock MA, Feldman SR, Coldiron BM. 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