Patient Reported Outcome Measures After Treatment of Skin Cancers on the Face

Study Overview
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Brief Summary
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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.

Official Title
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Patient Reported Outcome Measures After Treatment of Skin Cancers on the Face - a Pilot Study

Conditions
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Skin Cancer

Intervention / Treatment
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* Other: data collection by questionnaires
* Other: data collection (photos of the patients' tumors)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: individuals diagnosed with melanoma, SCC and/or infiltrative basal cell carcinoma on the face for surgical treatment and planned for excision or Mohs surgery patients who are able to give informed consent Exclusion Criteria: Electrodesication and curettage of the tumour

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: data collection by questionnaires|psychological well-being in patients evaluated by Patient Reported Outcomes (PRO)|
|Other: data collection (photos of the patients' tumors)|photos of the patients' tumors will be taken at baseline and at follow-up after the surgery|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melanoma, SCC in the face, infiltrative basal cell carcinoma on the face, Mohs Surgery