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Assessment of Disease Burden and Palliative Care Needs of Patients During the Course of Incurable Cancer Disease

NCT ID: NCT02751723

Last Updated: 2019-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2019-10-31

Brief Summary

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The aim of this non-investigational study is to determine the symptoms and disease burden at the time point of diagnosis and in the further course of an incurable cancer disease. The needs and preferences of patients suffering from cancer (ovarian carcinoma, breast cancer, malignant melanoma, lung cancer, stomach cancer, oesophageal cancer, pancreatic cancer, cancer of the hepatobiliary system, colorectal cancer, head and neck cancer) are examined by various validated questionnaires. The data obtained by these questionnaires are collected together with information obtained by the treating physicians at four time points during the study: t0 - patient´s enrollment, at the moment of diagnosis and before the start of tumor therapy, respectively; T1 - 3 months after patient´s enrollment; T2 - 6 months after patient´s enrollment; T3 - 12 months after patient´s enrollment. This highly innovative project offers the chance to identify medical services deficits and risk circumstances for the burden of treatments in an oncology-palliative setting and to optimize the quality of patient care.

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Detailed Description

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Conditions

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Cancer Disease, Palliative Therapy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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lung cancer

validated questionnaires

validated questionnaires

Intervention Type OTHER

malignant melanoma

validated questionnaires

validated questionnaires

Intervention Type OTHER

cancer of the hepatobiliary system

validated questionnaires

validated questionnaires

Intervention Type OTHER

head and neck cancer

validated questionnaires

validated questionnaires

Intervention Type OTHER

breast cancer

validated questionnaires

validated questionnaires

Intervention Type OTHER

ovarian carcinoma

validated questionnaires

validated questionnaires

Intervention Type OTHER

pancreatic cancer

validated questionnaires

validated questionnaires

Intervention Type OTHER

stomach cancer

validated questionnaires

validated questionnaires

Intervention Type OTHER

oesophageal cancer

validated questionnaires

validated questionnaires

Intervention Type OTHER

colorectal cancer

validated questionnaires

validated questionnaires

Intervention Type OTHER

Interventions

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validated questionnaires

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Incurable cancer disease: ovarian carcinoma, breast cancer, malignant melanoma, lung cancer, stomach cancer, oesophageal cancer, pancreatic cancer, cancer of the hepatobiliary system, colorectal cancer, head and neck cancer
* signed and dated Inform Consent Form
* Age ≥ 18 years

Exclusion Criteria

* Patient is not able to understand and to answer questions
* Patient is in a critical health situation and is directly threatened due to cancer disease or the resulting complications
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Florian Lordick, MD

OTHER

Sponsor Role lead

Responsible Party

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Florian Lordick, MD

Prof. Dr. med. (MD, PhD)

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Florian Lordick, Prof. Dr.

Role: STUDY_CHAIR

University of Leipzig

Bend Alt-Epping, PD Dr.

Role: STUDY_CHAIR

University of Göttingen

Anja Mehnert, Prof. Dr.

Role: STUDY_CHAIR

University of Leipzig

Birgitt van Oorschot, Prof. Dr.

Role: STUDY_CHAIR

Comprehensive Cancer Centre Main-Franken, Würzburg

Michael Thomas, Prof. Dr.

Role: STUDY_CHAIR

Heidelberg University

Locations

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UCCL, University of Leipzig

Leipzig, Saxony, Germany

Site Status

Municipal Hospital Braunschweig

Braunschweig, , Germany

Site Status

Internal medicine practice

Burgwedel, , Germany

Site Status

Municipal Hospital Essen-Mitte

Essen, , Germany

Site Status

University of Essen

Essen, , Germany

Site Status

University of Göttingen

Göttingen, , Germany

Site Status

University of Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Medical University Hanover

Hanover, , Germany

Site Status

Clinic for Thoraric Diseases (Thoraxklinik)

Heidelberg, , Germany

Site Status

Municipal Hospital Karlsruhe

Karlsruhe, , Germany

Site Status

University of Leipzig, ENT

Leipzig, , Germany

Site Status

Hospital Leverkusen

Leverkusen, , Germany

Site Status

Municipal Hospital Magdeburg

Magdeburg, , Germany

Site Status

University of Mainz

Mainz, , Germany

Site Status

Maria Hilf Clinic

Mönchengladbach, , Germany

Site Status

Radiotherapy practice

Recklinghausen, , Germany

Site Status

University of Regensburg

Regensburg, , Germany

Site Status

Hospital Südstadt Rostock

Rostock, , Germany

Site Status

Immanuel Hospital Rüdersdorf

Rüdersdorf, , Germany

Site Status

Hospital Traunstein

Traunstein, , Germany

Site Status

Comprehensive Cancer Centre Main-Franken

Würzburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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DRKS00007536

Identifier Type: REGISTRY

Identifier Source: secondary_id

APM Project

Identifier Type: -

Identifier Source: org_study_id

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