Trial document




drksid header

  DRKS00017003

Trial Description

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Title

Advance Care Planning - wishes and views of patients with incurable cancer towards consultations for end-of-life treatment decisions

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Trial Acronym

APM-ACP-Project

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Advance care planning (ACP) is a highly relevant subject especially for patients suffering from incurable cancer. The utmost concern is meeting patients needs at the end of life in order to maintain their self-determination. Currently there are different research approaches focusing on how to strenghthen patients during the process of ACP. In anglo american countries ACP is already partly implemented regionally and/or nationally. In Germany there is still limited experience in terms of incurable cancer patients. The aim of this project is to assess wishes and views of patients with incurable cancer towards consultations for end-of-life treatment decisions. The findings of this project will contribute to establish ACP according to patients needs at oncological centres, institutes and clinics.

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Brief Summary in Scientific Language

Description of possibilities, ressources and standards of current und future practice of ACP at oncological centres, institutes and clinics.
Description of patients wishes and views, their information needs and statisfaction in terms of consultations for end-of-life treatment decisions. Description of oncological treatment and goals of care and additional treatment information collected by the attending physician at two time points during the study: t0 – patient´s enrollment and t1– 12 months after patient´s enrollment

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Organizational Data

  •   DRKS00017003
  •   2019/04/15
  •   [---]*
  •   yes
  •   Approved
  •   290/18-ek , Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Incurable cancer diagnosis
  •   C33 -  Malignant neoplasm of trachea
  •   C34 -  Malignant neoplasm of bronchus and lung
  •   C22 -  Malignant neoplasm of liver and intrahepatic bile ducts
  •   C23 -  Malignant neoplasm of gallbladder
  •   C24 -  Malignant neoplasm of other and unspecified parts of biliary tract
  •   C25 -  Malignant neoplasm of pancreas
  •   C18 -  Malignant neoplasm of colon
  •   C19 -  Malignant neoplasm of rectosigmoid junction
  •   C20 -  Malignant neoplasm of rectum
  •   C21 -  Malignant neoplasm of anus and anal canal
  •   C22 -  Malignant neoplasm of liver and intrahepatic bile ducts
  •   C50 -  Malignant neoplasm of breast
  •   C15 -  Malignant neoplasm of oesophagus
  •   C16 -  Malignant neoplasm of stomach
  •   C61 -  Malignant neoplasm of prostate
  •   C64 -  Malignant neoplasm of kidney, except renal pelvis
  •   C67 -  Malignant neoplasm of bladder
  •   C51 -  Malignant neoplasm of vulva
  •   C53 -  Malignant neoplasm of cervix uteri
  •   C54 -  Malignant neoplasm of corpus uteri
  •   C55 -  Malignant neoplasm of uterus, part unspecified
  •   C56 -  Malignant neoplasm of ovary
  •   C00 -  Malignant neoplasm of lip
  •   C14 -  Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx
  •   C32 -  Malignant neoplasm of larynx
  •   C70 -  Malignant neoplasm of meninges
  •   C71 -  Malignant neoplasm of brain
  •   C72 -  Malignant neoplasm of spinal cord, cranial nerves and other parts of central nervous system
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Interventions/Observational Groups

  •   Questionnaire für patients with diagnosed incurable cancer (cancerof ovaries, cervical and endometrial cancer, breast cancer, malignant melanoma, lung cancer, oesophageal cancer, stomach cancer, pancreatic cancer, hepatobiliary cancer , colorectal cancer, head- and neck-cancer) at t0, Case report form for the attending physician at t0 and t1 (= t0 + 12months)
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Characteristics

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

1. General understanding of ACP and current ACP-practice in oncological centres, institutes and clinics
2. Practice of ACP-consultation
3. Information and counselling needs of patients 4. Existence of ACP-documents of ACP (e.g. advance directive, health care proxy)
5. Performance of lifesustaining and/or resuscitating treatment

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Secondary Outcome

1. QoL of patient
2. Psychosocial burden of patients
3. Understanding of disease and goals of oncological care of patients
4. Patients satisfaction with care

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Planned
  •   2019/04/15
  •   200
  •   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
• Signed and dated informed consent
• Full understanding of german language
• Ability to participate in a 15min interview

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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

  • start of 1:1-Block address primary-sponsor
    • UCCL desUniversitätsklinikum Leipzig
    • Mr.  Prof. Dr. med.   Florian  Lordick 
    • Liebigstr. 22
    • 04103  Leipzig
    • Germany
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    • UCCL des Universitätsklinikum LeipzigHaus 7
    • Mr.  Prof. Dr. med.  Florian  Lordick 
    • Liebigstr. 22
    • 04103  Leipzig
    • Germany
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    • UCCL des Universitätsklinikum Leipzig Haus 7
    • Ms.  Astrid  Schnabel 
    • Liebigstr. 22
    • 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 planned
  •   [---]*
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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.