Trial document



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  DRKS00000539

Trial Description

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Title

Efficacy of a combined shared decision-making intervention including a training program for oncologists and decision aids for breast and colon cancer patients

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Trial Acronym

PPO

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URL of the Trial

http://www.pefmed.de

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Brief Summary in Lay Language

Many cancer patients wish to get detailed information about their condition and treatment options as well as to participate in medical decision making. The enhancement of participation in medical decision making can reduce decisional conflict and psychological distress. Clinical studies show, that patients are more satisfied with their treatment and suffer less anxiety and depressive symptoms after being actively involved in the decision making process. To enhance patient participation, a combination of training for oncologists and decision boards for the patients has been shown to be effective. In this study, the efficacy of a training program for shared decision-making in combination with decision boards will be investigated. Aim of this combined intervention is to reduce decional conflict, to enhance satisfaction with the treatment decisions and also to reduce psychological distresss.

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Brief Summary in Scientific Language

Aim of the Study:
To adapt and evaluate a combined shared decision making intervention consisting of a training program for oncologists and decision boards for patients suffering from primary breast cancer or colon cancer. Primary hypotheses are that the intervention reduces decisional conflict and enhances satisfaction with medical decisions. Secondary hypothesis is that patients in the intervention group experience less psychological distress. Furthermore, we expect better communication skill in the trained oncologists compared to the control condition.

Design and Methods:
In a Cluster-randomized controlled trial, 50 oncologists (25 in the intervention and control group each) and 400 patients with primary breast cancer or colon cancer will be included. The intervention consists of an existing training manual that has been evaluated for other medical conditions (depression, fibromyalgia) and decision boards. The decision boards will be developed during the first phase of the study. After a baseline assessment (audio-taped consultation), each participating oncologist will include 8 patients in the study. All consultations are audiotaped. In addition, patients and oncologists complete a questionnaire immediately after the consultation. Patients receive a postal follow-up questionnaire 3 months after the consultation.

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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

  •   DRKS00000539
  •   2010/10/07
  •   2007/06/01
  •   yes
  •   Approved
  •   274/06, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   UKF001133  (Register klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
  •   C18 -  Malignant neoplasm of colon
  •   C19 -  Malignant neoplasm of rectosigmoid junction
  •   C20 -  Malignant neoplasm of rectum
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Interventions/Observational Groups

  •   Training program for oncologists including
    - theoretical background of shared decision-making
    - implementation of SDM techniques in the medical encounter
    - risk communication
    - usage of decision boards

    Part two of the combined intervention are decision boards for several medical decisions in the treatment of primary breast cancer and colon cancer
  •   no intervention, treatment as usual (TAU)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

1) Decisional Conflict (Decisional Conflict Scale; O'Connor et al., 2005).
2) Saticfaction with Decision (Saticfaction with Decision Scale; Holmes-Rovner, 1996)

Both primary endpoints are assessed by psychometrically defined scales. Patients complete a questionnaire including these scales immediately after the medical consultation. We expect the decisional conflict to be lower and the satisfaction with decision to be higher in the intervention group, compared with the control group.

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Secondary Outcome

• Quality of the doctor-patient relationship: operationalized by the German translation of the consultation and relational empathy (CARE; (Neumann, Wirtz, Bollschweiler, Warm, Wolf & Pfaff, 2008))

• Shared decision-Making is assesed with the OPTION Scale (Elwyn et al. 2005) and the Shared-Decision Making Questionnaire-9 (Kriston et al. 2009)

The OPTION Scale is a coding system for audio-or video-taped consultations - blinded study assistants will rate the extent of shared decision making in the consultation. All other outcomes are included in a patient questionnaire that will be completed immediately after the consultation.
• Anxiety and Depression: German Version of the Hospital Anxiety and Depression Scalen (HADS-D; Herrmann-Lingen, Buss & Snaith, 1995)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2010/01/27
  •   400
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

- patients suffering from primary breast cancer or colon cancer facing a medical decision
- informed consent for study participation

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Exclusion Criteria

- Cancer Patients that do not face a medical decision
- secondary tumors
- distant metastases
- medical contraindications
- insufficiant knowledge of German language

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Addresses

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    • Universitätsklinikum Freiburg Psychiatrie und Psychotherapie Sektion Klinische Epidemiologie und Versorgungsforschung
    • Mr.  Prof. Dr. Dr.  Martin  Härter 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
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    • Universitätsklinikum Heidelberg Klinik für Psychosomatische und Allgemeine Klinische Medizin
    • Ms.  Dr. med.  Christiane  Bieber 
    • Thibautstraße 2
    • 69115  Heidelberg
    • Germany
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    • Universitätsklinik für Psychiatrie und Psychosomatik - Psychiatrie und Psychotherapie
    • Ms.  Dr.  Katrin  Reuter 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Krebshilfe e.V.
    • Ms.  Annika  Thiel 
    • Buschstr. 32
    • 53113  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/06/05
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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.