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

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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

Tracking Information
First Submitted Date April 14, 2016
First Posted Date April 26, 2016
Last Update Posted Date March 7, 2019
Study Start Date September 2014
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 21, 2016)
Change from Baseline Patient´s answers regarding symptom burden at 12 months [ Time Frame: 12 months after enrollment ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02751723 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 21, 2016)
  • Change from Baseline physician´s report at 12 months [ Time Frame: 12 months after enrollment ]
  • Change from Baseline Patient´s answers regarding symptom burden at 6 months [ Time Frame: 6 months after enrollment ]
  • Change from Baseline physician´s report at 6 months [ Time Frame: 6 months after enrollment ]
  • Change from Baseline Patient´s answers regarding symptom burden at 3 months [ Time Frame: 3 months after enrollment ]
  • Change from Baseline physician´s report at 3 months [ Time Frame: 3 months after enrollment ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients with newly diagnosed incurable cancer disease before start of any tumor therapy
Condition Cancer Disease, Palliative Therapy
Intervention Other: validated questionnaires
Study Groups/Cohorts
  • lung cancer
    validated questionnaires
    Intervention: Other: validated questionnaires
  • malignant melanoma
    validated questionnaires
    Intervention: Other: validated questionnaires
  • cancer of the hepatobiliary system
    validated questionnaires
    Intervention: Other: validated questionnaires
  • head and neck cancer
    validated questionnaires
    Intervention: Other: validated questionnaires
  • breast cancer
    validated questionnaires
    Intervention: Other: validated questionnaires
  • ovarian carcinoma
    validated questionnaires
    Intervention: Other: validated questionnaires
  • pancreatic cancer
    validated questionnaires
    Intervention: Other: validated questionnaires
  • stomach cancer
    validated questionnaires
    Intervention: Other: validated questionnaires
  • oesophageal cancer
    validated questionnaires
    Intervention: Other: validated questionnaires
  • colorectal cancer
    validated questionnaires
    Intervention: Other: validated questionnaires
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: April 21, 2016)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02751723
Other Study ID Numbers APM Project
DRKS00007536 ( Registry Identifier: Deutsches Register Klinischer Studien )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Florian Lordick, MD, University of Leipzig
Study Sponsor Florian Lordick, MD
Collaborators Not Provided
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
PRS Account University of Leipzig
Verification Date March 2019