NCT04485442

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

November 9, 2020

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

3.7 years

First QC Date

July 21, 2020

Last Update Submit

November 20, 2023

Conditions

Skin Cancer

Keywords

melanomaSCC in the faceinfiltrative basal cell carcinoma on the faceMohs Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in European Organization for Research and Treatment of Cancer (EORTC-QLQ-C30) questionnaire

    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

    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

    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

    at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery)

Interventions

data collection by questionnairesOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Electrodesication and curettage of the tumour

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Skin NeoplasmsMelanoma

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and Melanomas

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Dirk J Schaefer, Prof. Dr. med.

    Department of Plastic, Reconstructive and Aesthetic Surgery, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2020

First Posted

July 24, 2020

Study Start

November 9, 2020

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

November 21, 2023

Record last verified: 2023-11

Locations

CH(1)