Trial document




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  DRKS00013304

Trial Description

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Title

Identification and analysis of relevant attributes for choices for liver cancer therapies.

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Trial Acronym

IRALCT

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of the study is to identify the most important factors influencing the choice of therapy of malignant liver lesions from the patients’, the physicians’, and the medical laymen’s points of view. As a first step towards this goal, we want to gather information from 343 patients, 343 physicians and 343 medical laymen. Subsequently we plan to evaluate the collected data and publish the results. By this means, we hope to achieve sustainable improvements in the inclusion of the patient´s preferences in the decision making process about the choice of treatment.

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Brief Summary in Scientific Language

The aim of the preliminary study is to identify the relevant attributes of liver cancer therapies influencing the choice of therapy made by patients, medical professionals, and medical laymen. To collect the necessary data, a computer-based survey will be conducted with all three groups of participants, each containing 343 individuals. In this preliminary study, we will use the maximum difference scaling method to create a ranking over 14 preselected attributes for each group, from the most important to the least important attribute. As a first result we will see if the groups rate the attributes differently regarding their perceived relevance and which group prefers which treatment. The set of the highest ranked attributes serves as the starting point for the main study.
In the main study, we will use the method of Choice-Based Conjoint Analysis. The goal of this analysis is to determine part-worth utilities of the highest ranked attributes and to investigate the total utilities of treatment options. In addition, the main study aims to reveal the patients’ preferences for specific treatment options that, if medically justified, might be taken into account in future decision-making processes by medical professionals. The results can improve medical treatment in terms of evidence-based medicine and shared decision-making, and thereby increase the satisfaction (welfare) of both patients and physicians.

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Organizational Data

  •   DRKS00013304
  •   2017/11/16
  •   [---]*
  •   yes
  •   Approved
  •   3561-2017, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  •   U1111-1204-8265 
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Health Condition or Problem studied

  •   C22.9 -  Malignant neoplasm: Liver, unspecified
  •   C78.7 -  Secondary malignant neoplasm of liver and intrahepatic bile duct
  •   C24.9 -  Malignant neoplasm: Biliary tract, unspecified
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Interventions/Observational Groups

  •   A computer-based survey will be conducted with participants to identify relevent attributes of liver cancer therapies. Each group will edit the same questionaire. The participants were interviewed once.
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Characteristics

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

The main study aims to reveal the patients’ preferences for specific treatment options that, if medically justified, might be taken into account in future decision-making processes by medical professionals. The results can improve medical treatment in terms of evidence-based medicine and shared decision-making, and thereby increase the satisfaction (welfare) of both patients and physicians.

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Secondary Outcome

The aim of the preliminary study is to identify the relevant attributes of liver cancer therapies influencing the choice of therapy.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/11/16
  •   1029
  •   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

The study includes full aged liver cancer patients from Hannover Medical School who undergo a minimal invasive therapy e.g. thermal ablation, selective chemotherapy/radiotherapy, and surgical treatment. Moreover, we interview physicians stationed in the gastroenterology and medical nonprofessionals

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Exclusion Criteria

Underage persons, critically ill and unstable patients, and patients who have participated in another study within the last 30 days are excluded from the study. Another exclusion criterion is to terminate the survey upon request. In order to determine the eligibility of a patient, the treating physician will ensure the examination of the medical exclusion criteria.

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Addresses

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    • Medizinische Hochschule Hannover
    • Carl-Neuberg Straße 1
    • 30625  Hannover
    • Germany
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    • Otto-von-Guericke-Universität Magdeburg
    • Ms.  Carolin  Deistler 
    • Universitätsplatz 2
    • 39106  Magdeburg
    • Germany
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    • Medizinische Hochschule Hannover
    • Mr.  Dr.  Bennet  Hensen 
    • Carl-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung
    • Kapelle-Ufer 1
    • 10117  Berlin
    • Germany
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    • EU-EFRE Sachsen Anhalt Verwaltungsbehörde für EFRE /ESF im Ministerium der Finanzen
    • Editharing 40
    • 39108  Magdeburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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