Trial document




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  DRKS00007536

Trial Description

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Title

Determination of burden and requirements of therapies for patients during the course of incurable cancer disease

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Trial Acronym

APM-Project

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URL of the Trial

http://none

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Brief Summary in Lay Language

The aim of this non-investigational study is to determine the symptoms and burden at the moment 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) will be examined by various questionnaires. The data obtained by these questionnaires will be 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 the patient´s enrollment; T2 – 6 months after the patient´s enrollment; T3 – 12 months after the 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.

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Brief Summary in Scientific Language

The aim of this non-investigational study is to determine the symptoms and burden at the moment 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) will be examined by various questionnaires. The data obtained by these questionnaires will be 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 the patient´s enrollment; T2 – 6 months after the patient´s enrollment; T3 – 12 months after the 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.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00007536
  •   2014/11/27
  •   [---]*
  •   yes
  •   Approved
  •   275/14-25082014, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  •   U1111-1164-2967 
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Health Condition or Problem studied

  •   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)
  •   C56 -  Malignant neoplasm of ovary
  •   C50 -  Malignant neoplasm of breast
  •   C43-C44 -  Melanoma and other malignant neoplasms of skin
  •   C34 -  Malignant neoplasm of bronchus and lung
  •   C16 -  Malignant neoplasm of stomach
  •   C15 -  Malignant neoplasm of oesophagus
  •   C25 -  Malignant neoplasm of pancreas
  •   C22 -  Malignant neoplasm of liver and intrahepatic bile ducts
  •   C18 -  Malignant neoplasm of colon
  •   C19 -  Malignant neoplasm of rectosigmoid junction
  •   C20 -  Malignant neoplasm of rectum
  •   C00-C14 -  Malignant neoplasms of lip, oral cavity and pharynx
  •   C30 -  Malignant neoplasm of nasal cavity and middle ear
  •   C31 -  Malignant neoplasm of accessory sinuses
  •   C32 -  Malignant neoplasm of larynx
  •   C23 -  Malignant neoplasm of gallbladder
  •   C24 -  Malignant neoplasm of other and unspecified parts of biliary tract
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Interventions/Observational Groups

  •   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);
    The aim of this non-investigational study is to determine the symptoms and burden at the moment of diagnosis and in the further course of an incurable cancer disease. The needs and preferences of patients suffering from cancer will be examined by various questionnaires (FACIT, PHQ4, SCNS-34 in condensed form, SEIQol-Q, Distress Thermometer). The data obtained by these questionnaires will be collected together with information obtained by the treating physicians (information regarding demography, anamnesis and cancer treatment) 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 the patient´s enrollment; T2 – 6 months after the patient´s enrollment; T3 – 12 months after the patient´s enrollment.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Health care system
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

What?: Burden by symptoms
When?: T0 – patient´s enrollment, at the moment of diagnosis and before the start of tumor therapy, respectively; T1 – 3 months after the patient´s enrollment; T2 – 6 months after the patient´s enrollment; T3 – 12 months after the patient´s enrollment
How?: FACIT - questionnaire

What?: Care Needs
When?: T0 – patient´s enrollment, at the moment of diagnosis and before the start of tumor therapy, respectively; T1 – 3 months after the patient´s enrollment; T2 – 6 months after the patient´s enrollment; T3 – 12 months after the patient´s enrollment
How?: SCNS-34 - questionnaire (in condensed form)

What?: Stress
When?: T0 – patient´s enrollment, at the moment of diagnosis and before the start of tumor therapy, respectively; T1 – 3 months after the patient´s enrollment; T2 – 6 months after the patient´s enrollment; T3 – 12 months after the patient´s enrollment
How?: Distress Thermometer


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Secondary Outcome

What?: Psychic comorbidity
When?: T0 – patient´s enrollment, at the moment of diagnosis and before the start of tumor therapy, respectively; T1 – 3 months after the patient´s enrollment; T2 – 6 months after the patient´s enrollment; T3 – 12 months after the patient´s enrollment
How?: PHQ4 questionnaire

What?: Quality of Life
When?: T0 – patient´s enrollment, at the moment of diagnosis and before the start of tumor therapy, respectively; T1 – 3 months after the patient´s enrollment; T2 – 6 months after the patient´s enrollment; T3 – 12 months after the patient´s enrollment
How?: SEIQol-Q questionnaire

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2014/12/22
  •   500
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Universität Leipzig, Universitäres Krebszentrum Leipzig
    • Mr.  Prof. Dr.   Florian   Lordick 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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    • Universität Leipzig; UCCL
    • Mr.  Prof. Dr.  Florian  Lordick 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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    • Universität Leipzig; UCCL
    • Ms.  Dr.  Jeannette  Vogt 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Krebsgesellschaft e.V.
    • Kuno-Fischer-Str. 8
    • 14057  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.