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

• Conditions: Cancer Disease, Palliative Therapy
• Interventions: Other: validated questionnaires

• Registration Number: NCT02751723
• Lead Sponsor: Florian Lordick, MD

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-04-14
• Study First Submitted QC: 2016-04-21
• Study First Posted: 2016-04-26
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-07
• Primary Completion: 2019-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
head and neck cancer	validated questionnaires	validated questionnaires
ovarian carcinoma	validated questionnaires	validated questionnaires
oesophageal cancer	validated questionnaires	validated questionnaires
pancreatic cancer	validated questionnaires	validated questionnaires
lung cancer	validated questionnaires	validated questionnaires
breast cancer	validated questionnaires	validated questionnaires
stomach cancer	validated questionnaires	validated questionnaires
colorectal cancer	validated questionnaires	validated questionnaires
malignant melanoma	validated questionnaires	validated questionnaires
cancer of the hepatobiliary system	validated questionnaires	validated questionnaires

Primary Outcome Measures

Name	Time	Method
Change from Baseline Patient´s answers regarding symptom burden at 12 months	12 months after enrollment

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Patient´s answers regarding symptom burden at 3 months	3 months after enrollment
Change from Baseline physician´s report at 3 months	3 months after enrollment
Change from Baseline physician´s report at 6 months	6 months after enrollment
Change from Baseline physician´s report at 12 months	12 months after enrollment
Change from Baseline Patient´s answers regarding symptom burden at 6 months	6 months after enrollment

Trial Locations

Locations (21)

Municipal Hospital Braunschweig; 🇩🇪 Braunschweig, Germany

Internal medicine practice; 🇩🇪 Burgwedel, Germany

Municipal Hospital Essen-Mitte; 🇩🇪 Essen, Germany

University of Göttingen; 🇩🇪 Göttingen, Germany

UCCL, University of Leipzig; 🇩🇪 Leipzig, Saxony, Germany

Clinic for Thoraric Diseases (Thoraxklinik); 🇩🇪 Heidelberg, Germany

Municipal Hospital Magdeburg; 🇩🇪 Magdeburg, Germany

University of Mainz; 🇩🇪 Mainz, Germany

University of Regensburg; 🇩🇪 Regensburg, Germany

University of Essen; 🇩🇪 Essen, Germany

University of Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

University of Leipzig, ENT; 🇩🇪 Leipzig, Germany

Medical University Hanover; 🇩🇪 Hanover, Germany

Municipal Hospital Karlsruhe; 🇩🇪 Karlsruhe, Germany

Hospital Leverkusen; 🇩🇪 Leverkusen, Germany

Hospital Südstadt Rostock; 🇩🇪 Rostock, Germany

Immanuel Hospital Rüdersdorf; 🇩🇪 Rüdersdorf, Germany

Comprehensive Cancer Centre Main-Franken; 🇩🇪 Würzburg, Germany

Maria Hilf Clinic; 🇩🇪 Mönchengladbach, Germany

Radiotherapy practice; 🇩🇪 Recklinghausen, Germany

Hospital Traunstein; 🇩🇪 Traunstein, Germany