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Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00008921
Date of registration:	06/09/2017
Prospective Registration:	No
Primary sponsor:	Medizinische Hochschule Hannover, Klinik und Gesichtschirurgie
Public title:	Developing a screening for distress during cancer– A prospective longitudinal study of patients with oral cancer.
Scientific title:	Developing a screening for distress during cancer– A prospective longitudinal study of patients with oral cancer.
Date of first enrolment:	13/04/2016
Target sample size:	100
Recruitment status:	Recruiting
URL:	http://drks.de/search/en/trial/DRKS00008921
Study type:	observational
Study design:	Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: other
Phase:

Countries of recruitment
Germany

Contacts

Name:	Majeed Rana
Address:	Carl Neuberg Straße 1 30625 Hannover Germany
Telephone:	+49-511-532-4716
Email:	rana.majeed at mh-hannover.de
Affiliation:	Medizinische Hochschule Hannover, Klinik und Poliklinik für Mund-, Kiefer-, und Gesichtschirurgie

Name:	Madiha Rana
Address:	Holstenhofweg 85 22043 Hamburg Germany
Telephone:	+49-40-6541-2932
Email:	rana at hsu-hh.de
Affiliation:	Helmut-Schmidt-Universität, Universität der Bundeswehr

Key inclusion & exclusion criteria

Inclusion criteria: squamous cell carcinoma

majority

Written informed consent
Exclusion criteria: No possibility for follow-up survey,

drug addiction,

mental disability,
need of a carer

Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Other malignant neoplasms of skin

C44

Intervention(s)

Group 1: Patients with squamous cell carcinoma are asked about their personality , their personal resources and their current burdens and demographic data prior to biopsy ( T1 ) , after their surgery ( T2 ) 3months after ( T3 ) , six months thereafter, and be interviewed nine months thereafter. Moreover partners need to fill out the screening and another questionnaire to ensure external validation

Primary Outcome(s)

Patients will be asked about their personality , personal resources, their distress level and demographic data prior to biopsy ( T1 ) , after their surgery ( T2 ) 3months after ( T3 ) , six months thereafter, and 9 months are surveyed after terms They shall fill out a newly developed screening and the Distress Thermometer .The aim is to vailidate the new screening

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Universitätsklinikum Düsseldorf

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 08/09/2015
Contact:

ethikkommission@mh-hannover.de

Ethikkommission der Medizinischen Hochschule Hannover

+49-511-5323443

ethikkommission@mh-hannover.de

Results

Results available:
Date Posted:
Date Completed:
URL:	http://drks.de/search/en/trial/DRKS00008921#studyResults

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