Assessment of Disease Burden and Palliative Care Needs of Patients During the Course of Incurable Cancer Disease (APM-Project)
March 6, 2019 updated by: Florian Lordick, MD
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Braunschweig, Germany
- Municipal Hospital Braunschweig
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Burgwedel, Germany
- Internal medicine practice
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Essen, Germany
- University of Essen
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Essen, Germany
- Municipal Hospital Essen-Mitte
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Göttingen, Germany
- University of Göttingen
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Hamburg, Germany
- University of Hamburg-Eppendorf
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Hanover, Germany
- Medical University Hanover
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Heidelberg, Germany
- Clinic for Thoraric Diseases (Thoraxklinik)
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Karlsruhe, Germany
- Municipal Hospital Karlsruhe
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Leipzig, Germany
- University of Leipzig, ENT
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Leverkusen, Germany
- Hospital Leverkusen
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Magdeburg, Germany
- Municipal Hospital Magdeburg
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Mainz, Germany
- University of Mainz
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Mönchengladbach, Germany
- Maria Hilf Clinic
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Recklinghausen, Germany
- Radiotherapy practice
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Regensburg, Germany
- University of Regensburg
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Rostock, Germany
- Hospital Südstadt Rostock
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Rüdersdorf, Germany
- Immanuel Hospital Rüdersdorf
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Traunstein, Germany
- Hospital Traunstein
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Würzburg, Germany
- Comprehensive Cancer Centre Main-Franken
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Saxony
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Leipzig, Saxony, Germany, 04103
- UCCL, University of Leipzig
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with newly diagnosed incurable cancer disease before start of any tumor therapy
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
lung cancer
validated questionnaires
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malignant melanoma
validated questionnaires
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|
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cancer of the hepatobiliary system
validated questionnaires
|
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head and neck cancer
validated questionnaires
|
|
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breast cancer
validated questionnaires
|
|
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ovarian carcinoma
validated questionnaires
|
|
|
pancreatic cancer
validated questionnaires
|
|
|
stomach cancer
validated questionnaires
|
|
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oesophageal cancer
validated questionnaires
|
|
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colorectal cancer
validated questionnaires
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from Baseline Patient´s answers regarding symptom burden at 12 months
Time Frame: 12 months after enrollment
|
12 months after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from Baseline physician´s report at 12 months
Time Frame: 12 months after enrollment
|
12 months after enrollment
|
|
Change from Baseline Patient´s answers regarding symptom burden at 6 months
Time Frame: 6 months after enrollment
|
6 months after enrollment
|
|
Change from Baseline physician´s report at 6 months
Time Frame: 6 months after enrollment
|
6 months after enrollment
|
|
Change from Baseline Patient´s answers regarding symptom burden at 3 months
Time Frame: 3 months after enrollment
|
3 months after enrollment
|
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Change from Baseline physician´s report at 3 months
Time Frame: 3 months after enrollment
|
3 months after enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Anticipated)
October 1, 2019
Study Completion (Anticipated)
October 1, 2019
Study Registration Dates
First Submitted
April 14, 2016
First Submitted That Met QC Criteria
April 21, 2016
First Posted (Estimate)
April 26, 2016
Study Record Updates
Last Update Posted (Actual)
March 7, 2019
Last Update Submitted That Met QC Criteria
March 6, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- APM Project
- DRKS00007536 (Registry Identifier: Deutsches Register Klinischer Studien)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.