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This study is to evaluate the psychological well-being in patients diagnosed with skin cancer (melanoma and Squamous Cell Carcinoma (SCC) in the face) at the time of diagnosis and after treatment. Patients diagnosed with primary melanoma and/or SCC and/or infiltrative basal cell carcinoma on the face subjected to surgical treatment (excision or Mohs Surgery) will be included. All patients will receive questionnaires.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| data collection by questionnaires | Other | psychological well-being in patients evaluated by Patient Reported Outcomes (PRO) | ||
| data collection (photos of the patients' tumors) | Other | photos of the patients' tumors will be taken at baseline and at follow-up after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Belastungs-Thermometer questionnaire | extent of distress on a scale from 0-10 (0=no distress, 10=extremely distress). | at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in European Organization for Research and Treatment of Cancer (EORTC-QLQ-C30) questionnaire | TheEORTC- QLQ-C30 is composed of both multiitem scales and single-item measures. These include 5 functional scales (cognitive, CF; emotional, EF; physical, PF; role, RF; and social functioning, SF), 3 symptom scales (fatigue, FA; nausea/vomiting, NV; and pain, PA), a global health status/QoL scale and 5 single items assessing additional symptoms (appetite loss, AP; constipation, CO; diarrhea, DI; dyspnea, DY; and sleep disturbance, SL) and perceived financial impact, FI. Each of the multiitem scales includes a different set of items-no item occurs in more than 1 scale. All of the scales and single-item measures range in score from 0-100. A high scale score represents a higher response level. |
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Inclusion Criteria:
Exclusion Criteria:
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All patients diagnosed with melanoma, SCC and /or infiltrative basal cell carcinoma on the face are eligible for the study and will be recruited at the Department of Dermatology and Plastic Surgery at University Hospital Basel.
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| Name | Affiliation | Role |
|---|---|---|
| Dirk J Schaefer, Prof. Dr. med. | Department of Plastic, Reconstructive and Aesthetic Surgery, University Hospital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Plastic, Reconstructive and Aesthetic Surgery and Department of Dermatology , University Hospital Basel | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery) |
| Change in WHO-DAS questionnaire | The WHO-DAS measures items in six domains of functioning as experienced over the past 30 days: mobility, self-care, life activities, understanding and communicating (U&C), interpersonal interactions, and participation in society. The 12-item tool assesses each domain with two items that are measured on a 3-point scale in which 1 indicates no disability, 2 indicates mild to moderate disability, and 3 indicates severe to extreme disability. These items were summed to generate a total score between 12 (no disability) and 36 (maximum disability). | at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery) |
| Change in FACE-Q questionnaire | The FACE-Q questionnaire measures three overarching domains: facial appearance, quality of life and experience of care over the past 7 days. The FACE-Q Skin Cancer Module is composed of 56 items with scales from 1-4 which range in scoring from 0-100. The FACE-Q Skin Cancer module includes two quality of life scales measuring appearance-related distress and skin cancer worry. Additionally, the participants will be asked about skin protection behaviours and adverse events following the skin cancer treatment. The FACE-Q appearance scale consists of satisfaction with the appearance of the face overall and how bothered a patient is by facial scars | at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery) |
| Change in photos of the patients' tumors | Change in photos of the patients' tumors | at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery) |
| D018358 |
| Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |