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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Skin Cancer
• Intervention / Treatment: Other: data collection by questionnaires; Other: data collection (photos of the patients' tumors)

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Department of Plastic, Reconstructive and Aesthetic Surgery and Department of Dermatology , University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Dirk J Schaefer, Prof. Dr. med., Department of Plastic, Reconstructive and Aesthetic Surgery, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: melanoma; Mohs Surgery; SCC in the face; infiltrative basal cell carcinoma on the face
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms
• Other Study ID Numbers: 2018-00301; ch20Schaefer2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No