Clinical trial NCT02751723: Assessment of Disease Burden and Palliative Care Needs of Patients During the Course of Incurable Cancer Disease
Official title: Assessment of Disease Burden and Palliative Care Needs of Patients During the Course of Incurable Cancer Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer Disease, Palliative Therapy
Keywords: cancer disease
palliative care
palliative therapy
cancer
patient´s needs
patient care
disease burden
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2016-04-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with newly diagnosed incurable cancer disease before start of any tumor therapy

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Patient´s answers regarding symptom burden at 12 months
timeFrame: 12 months after enrollment
Secondary outcomes:
measure: Change from Baseline physician´s report at 12 months
timeFrame: 12 months after enrollment
measure: Change from Baseline Patient´s answers regarding symptom burden at 6 months
timeFrame: 6 months after enrollment
measure: Change from Baseline physician´s report at 6 months
timeFrame: 6 months after enrollment
measure: Change from Baseline Patient´s answers regarding symptom burden at 3 months
timeFrame: 3 months after enrollment
measure: Change from Baseline physician´s report at 3 months
timeFrame: 3 months after enrollment
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: UCCL, University of Leipzig
state: Saxony
city: Braunschweig
country: Germany
facility: Municipal Hospital Braunschweig
city: Burgwedel
country: Germany
facility: Internal medicine practice
city: Essen
country: Germany
facility: Municipal Hospital Essen-Mitte
city: Essen
country: Germany
facility: University of Essen
city: Göttingen
country: Germany
facility: University of Göttingen
city: Hamburg
country: Germany
facility: University of Hamburg-Eppendorf
city: Hanover
country: Germany
facility: Medical University Hanover
city: Heidelberg
country: Germany
facility: Clinic for Thoraric Diseases (Thoraxklinik)
city: Karlsruhe
country: Germany
facility: Municipal Hospital Karlsruhe
city: Leipzig
country: Germany
facility: University of Leipzig, ENT
city: Leverkusen
country: Germany
facility: Hospital Leverkusen
city: Magdeburg
country: Germany
facility: Municipal Hospital Magdeburg
city: Mainz
country: Germany
facility: University of Mainz
city: Mönchengladbach
country: Germany
facility: Maria Hilf Clinic
city: Recklinghausen
country: Germany
facility: Radiotherapy practice
city: Regensburg
country: Germany
facility: University of Regensburg
city: Rostock
country: Germany
facility: Hospital Südstadt Rostock
city: Rüdersdorf
country: Germany
facility: Immanuel Hospital Rüdersdorf
city: Traunstein
country: Germany
facility: Hospital Traunstein
city: Würzburg
country: Germany
facility: Comprehensive Cancer Centre Main-Franken
Study officials:
affiliation: University of Leipzig
name: Florian Lordick, Prof. Dr.
role: STUDY_CHAIR
affiliation: University of Göttingen
name: Bend Alt-Epping, PD Dr.
role: STUDY_CHAIR
affiliation: University of Leipzig
name: Anja Mehnert, Prof. Dr.
role: STUDY_CHAIR
affiliation: Comprehensive Cancer Centre Main-Franken, Würzburg
name: Birgitt van Oorschot, Prof. Dr.
role: STUDY_CHAIR
affiliation: Heidelberg University
name: Michael Thomas, Prof. Dr.
role: STUDY_CHAIR
References: