Trial document




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  DRKS00012552

Trial Description

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Title

Patient involvement in multidisciplinary tumor conferences in breast cancer care – an exploratory study

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Trial Acronym

PINTU

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URL of the Trial

https://www.ukbonn.de/42256BC8002AF3E7/vwWebPagesByID/FC88253FD2502F6AC12580D700471829

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Brief Summary in Lay Language

A central instrument of the multidisciplinary care is the so-called multidisciplinary tumor conference (MTC). In MTC the diagnosis and the further treatment of cancer patients are being discussed and therapy recommendations are worked out. The study situation on the risks and benefits of the patient participation does not yet provide substantiated findings. In this study, MTCs in six breast centers in North Rhine-Westphalia, Germany, with and without patient participation are examined. Firstly, a) caregivers are invited to interviews, in which the feasibility of patient participation, as well as the quality of the decision-making shall be discussed. Subsequently, b) video- or audiotaped participatory observations in MTC are executed. Video- and transcribed audio data will be rated using an established rating scale. Lastly, c) patients participating and not participating in the MTC fill out a questionnaire before and after the discussion of their case in the MTC in a short survey.

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Brief Summary in Scientific Language

The treatment in oncology is rather complex and requires the cooperation of many specialists and multidisciplinary teams. A central instrument of the multidisciplinary care is the so-called multidisciplinary tumor conference (MTC). In MTC the diagnosis and the further treatment of cancer patients are being discussed and therapy recommendations are worked out. However, the study situation on the risks and benefits of the patient participation does not yet provide substantiated findings.

Therefore the target of the research project is to examine, how MTCs are arranged with and without the patient participation, and how the parties rate the patient participation. Research questions are: 1.) In what way do the MTCs with and without patient participation differ with regard to the organization, interaction and patient orientation? 2.) How do the patients experience the participation and which direct effects does the participation have? 3.) How do the caregivers assess the participation of patients in the MTCs with regard to feasibility and quality of the decision-making? On the base of these results the potential effects on the patient outcomes can be explored systematically and interventionally.

In an explorative study, MTCs in six North Rhine-Westphalian breast centers with and without patient participation are examined with a triangulation of different methods. In the qualitative part, caregivers are invited to focus group discussions, in which the feasibility of patient participations, as well as the quality of the decision-making shall be discussed. The results are evaluated by means of content analyses. Subsequently, videotaped participatory observations in MTC are executed. The data evaluation is taken out by means of a description and comparison of the organization of the MTC and by means of a diagram to assess the quality of MTC. In the quantitative part, patients participating in the MTC are being interviewed before and after the participation in a short survey about the topics anxiety, therapy confidence, health literacy and psychosocial need for information, as well as their expectations before and their experiences after the MTC. The evaluation of the questionnaire content is carried out by means of descriptive statistics and content analytical evaluations of unanswered questions. Furthermore, statistic tests on differences between the survey dates are carried out.

From the results, first indications of feasibility, risks and benefits of the patient participation in MTC for patients and caregivers can be derived. The results shall be discussed with patients and caregivers in workshops and also be nationally published.

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

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00012552
  •   2018/05/04
  •   [---]*
  •   yes
  •   Approved
  •   17-405, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  •   VfD_PINTU_17_003846  (Datenbank Versorgungsforschung des DNVF)
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Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
  •   D05 -  Carcinoma in situ of breast
  •   C51-C58 -  Malignant neoplasms of female genital organs
  •   D06 -  Carcinoma in situ of cervix uteri
  •   D07 -  Carcinoma in situ of other and unspecified genital organs
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Interventions/Observational Groups

  •   - Qualitative interviews (focus groups) with MTC provider (MTC with patient participation)
    - Quantitative patient survey using various (psychological, psychosocial and care) questionnaires and self-developed items before, after and four weeks after the MTC
    - Qualitative videographic non-participating observations of the MTC (MTC with patient participation)
  •   - Qualitative interviews (focus groups) with MTC providers (MTC without participation)
    - Qualitative videographic non-participating observations of MTC (MTC without patient participation)
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Health care system
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

- Patient-orientation in tumorconferences
- Analysis of the structure and process quality of tumoconferences
- Cognitive and emotional effects of participation in tumorconferences for patients
- Participative decision-making and patient-centered focus in tumorconferences from the perspective of patients and providers
- Conditions of decision-making in tumorconferences

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/04/13
  •   180
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

ICD10 C50.xx, ICD10 D05.xx, ICD10 C51-58.xx, ICD10 D06-07.xx, sufficient German language skills, physical and psychological ability to participate

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Exclusion Criteria

not meeting the inclusion criteria

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Addresses

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    • Institut für Medizinsoziologie, Versorgungsforschung und Rehabilitationswissenschaften
    • Eupener Straße 129
    • 50933  Köln
    • Germany
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    •   (0)221/478-97144
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    •   [---]*
    •   [---]*
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    • Universitätsklinikum Bonn, Forschungsstelle für Gesundheitskommunikation und Versorgungsforschung
    • Sigmund-Freud-Straße 25
    • 53127  Bonn
    • Germany
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    • Universitätsklinikum Bonn, Forschungsstelle für Gesundheitskommunikation und Versorgungsforschung
    • Ms.  Prof. Dr.  Nicole  Ernstmann 
    • Sigmund-Freud-Straße 25
    • 53127  Bonn
    • Germany
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    • Institut für Medizinsoziologie, Versorgungsforschung und Rehabilitationswissenschaften
    • Ms.  Jun.-Prof. Dr.  Lena  Ansmann 
    • Eupener Straße 129
    • 50933  Köln
    • Germany
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    • Universitätsklinikum Bonn, Forschungsstelle für Gesundheitskommunikation und Versorgungsforschung
    • Mr.  M.A.  Christian  Heuser 
    • Sigmund-Freud-Straße 25
    • 53127  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Krebshilfe e.V.
    • Buschstraße 32
    • 53113  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2020/02/29
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* This entry means the parameter is not applicable or has not been set.