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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT04485442

Studienbeginn:
November 2020

Letztes Update:
13.11.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Skin Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital, Basel, Switzerland

Collaborator:
-

Studienleiter

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

Kontakt

Studienlocations
(1 von 1)

Department of Plastic, Reconstructive and Aesthetic Surgery and Department of Dermatology , University Hospital Basel
4031 Basel
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Dirk J Schaefer, Prof. Dr. med.
Phone: 041 61 265 25 25
E-Mail: Dirk.Schaefer@usb.ch
» Ansprechpartner anzeigen

Studien-Informationen

Brief 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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Change in Belastungs-Thermometer questionnaire (Time Frame - at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery)):
extent of distress on a scale from 0-10 (0=no distress, 10=extremely distress).



Secondary outcome:

1. Change in European Organization for Research and Treatment of Cancer (EORTC-QLQ-C30) questionnaire (Time Frame - at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery)):
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.

2. Change in WHO-DAS questionnaire (Time Frame - at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery)):
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).

3. Change in FACE-Q questionnaire (Time Frame - at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery)):
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

4. Change in photos of the patients' tumors (Time Frame - 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

Geprüfte Regime

  • 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

Quelle: ClinicalTrials.gov


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