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

Skin Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04485442
• Other study ID #: 2018-00301; ch20Schaefer2
• Status: Active, not recruiting
• Start date: November 9, 2020
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Skin Cancer
• Skin Neoplasms

Intervention

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

Locations

Country	Name	City	State
Switzerland	Department of Plastic, Reconstructive and Aesthetic Surgery and Department of Dermatology , University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)