Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment of Disease Burden and Palliative Care Needs of Patients During the Course of Incurable Cancer Disease (APM-Project)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02751723
Recruitment Status : Active, not recruiting
First Posted : April 26, 2016
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Florian Lordick, MD, University of Leipzig

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.

Condition or disease Intervention/treatment
Cancer Disease, Palliative Therapy Other: validated questionnaires

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Assessment of Disease Burden and Palliative Care Needs of Patients During the Course of Incurable Cancer Disease
Study Start Date : September 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Group/Cohort Intervention/treatment
lung cancer
validated questionnaires
Other: validated questionnaires
malignant melanoma
validated questionnaires
Other: validated questionnaires
cancer of the hepatobiliary system
validated questionnaires
Other: validated questionnaires
head and neck cancer
validated questionnaires
Other: validated questionnaires
breast cancer
validated questionnaires
Other: validated questionnaires
ovarian carcinoma
validated questionnaires
Other: validated questionnaires
pancreatic cancer
validated questionnaires
Other: validated questionnaires
stomach cancer
validated questionnaires
Other: validated questionnaires
oesophageal cancer
validated questionnaires
Other: validated questionnaires
colorectal cancer
validated questionnaires
Other: validated questionnaires



Primary Outcome Measures :
  1. Change from Baseline Patient´s answers regarding symptom burden at 12 months [ Time Frame: 12 months after enrollment ]

Secondary Outcome Measures :
  1. Change from Baseline physician´s report at 12 months [ Time Frame: 12 months after enrollment ]
  2. Change from Baseline Patient´s answers regarding symptom burden at 6 months [ Time Frame: 6 months after enrollment ]
  3. Change from Baseline physician´s report at 6 months [ Time Frame: 6 months after enrollment ]
  4. Change from Baseline Patient´s answers regarding symptom burden at 3 months [ Time Frame: 3 months after enrollment ]
  5. Change from Baseline physician´s report at 3 months [ Time Frame: 3 months after enrollment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with newly diagnosed incurable cancer disease before start of any tumor therapy
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751723


Locations
Layout table for location information
Germany
UCCL, University of Leipzig
Leipzig, Saxony, Germany, 04103
Municipal Hospital Braunschweig
Braunschweig, Germany
Internal medicine practice
Burgwedel, Germany
Municipal Hospital Essen-Mitte
Essen, Germany
University of Essen
Essen, Germany
University of Göttingen
Göttingen, Germany
University of Hamburg-Eppendorf
Hamburg, Germany
Medical University Hanover
Hanover, Germany
Clinic for Thoraric Diseases (Thoraxklinik)
Heidelberg, Germany
Municipal Hospital Karlsruhe
Karlsruhe, Germany
University of Leipzig, ENT
Leipzig, Germany
Hospital Leverkusen
Leverkusen, Germany
Municipal Hospital Magdeburg
Magdeburg, Germany
University of Mainz
Mainz, Germany
Maria Hilf Clinic
Mönchengladbach, Germany
Radiotherapy practice
Recklinghausen, Germany
University of Regensburg
Regensburg, Germany
Hospital Südstadt Rostock
Rostock, Germany
Immanuel Hospital Rüdersdorf
Rüdersdorf, Germany
Hospital Traunstein
Traunstein, Germany
Comprehensive Cancer Centre Main-Franken
Würzburg, Germany
Sponsors and Collaborators
Florian Lordick, MD
Investigators
Layout table for investigator information
Study Chair: Florian Lordick, Prof. Dr. University of Leipzig
Study Chair: Bend Alt-Epping, PD Dr. University of Göttingen
Study Chair: Anja Mehnert, Prof. Dr. University of Leipzig
Study Chair: Birgitt van Oorschot, Prof. Dr. Comprehensive Cancer Centre Main-Franken, Würzburg
Study Chair: Michael Thomas, Prof. Dr. Heidelberg University

Layout table for additonal information
Responsible Party: Florian Lordick, MD, Prof. Dr. med. (MD, PhD), University of Leipzig
ClinicalTrials.gov Identifier: NCT02751723     History of Changes
Other Study ID Numbers: APM Project
DRKS00007536 ( Registry Identifier: Deutsches Register Klinischer Studien )
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Florian Lordick, MD, University of Leipzig:
cancer disease
palliative care
palliative therapy
cancer
patient´s needs
patient care
disease burden