Trial document





This trial has been registered retrospectively.
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  DRKS00000492

Trial Description

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Title

Communication skills training about clinical trials. A communication training for Oncologist

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

When oncologists disclose information about randomized clinical trials (RCT), they have to address requirements of high research standard and respect patients’ rights. This is one of the most difficult communication tasks and physicians lack adequate training. Only few Communication Skills Trainings (CST) concerning this topic have been developed. Results show the need for further improvement: focusing on individual needs of participants and evaluation in a randomized design.

We developed an individualized CST, focusing on individual learning goals derived from video-assessment, and integrated a coaching after the workshop. For evaluation, 40 physicians were randomly assigned to training or waiting control group. Training success was evaluated by blinded rater using a specific checklist to evaluate video-recorded standardized consultations with actor-patients (1). The physicians’ feeling of competence in general (2), after each consultation (3) and the satisfaction of actor-patients (4) were assessed using questionnaires.

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Brief Summary in Scientific Language

When oncologists disclose information about randomized clinical trials (RCT), they have to address requirements of high research standard and respect patients’ rights. This is one of the most difficult communication tasks and physicians lack adequate training. Only few Communication Skills Trainings (CST) concerning this topic have been developed. Results show the need for further improvement: focusing on individual needs of participants and evaluation in a randomized design.

Methods:
We developed an individualized CST, focusing on individual learning goals derived from video-assessment, and integrated a coaching after the workshop. For evaluation, 40 physicians were randomly assigned to training or waiting control group. Training success was evaluated by blinded rater using a specific checklist to evaluate video-recorded standardized consultations with actor-patients (1). The physicians’ feeling of competence in general (2), after each consultation (3) and the satisfaction of actor-patients (4) were assessed using questionnaires.

Expected Results:
The training will improve the communication skills of the participating medical doctors.

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Organizational Data

  •   DRKS00000492
  •   2010/07/22
  •   2008/03/27
  •   yes
  •   Approved
  •   180/06, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
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Secondary IDs

  •   UKF001580  (Register klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

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Interventions/Observational Groups

  •   The 17-hour long training combines a video-assessment, communication skills training and coaching. In the video-assessment individual learning goals are derived. These are used in the workshop and practised in in role play with actor-patients. In the Coaching there is a focus of how the individual learning goals are implemented in daily practise.
  •   The waiting-control group does not receive no training first. Later they participate on the intervention.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Single blind
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  •   Active control
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  •   Parallel
  •   N/A
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Primary Outcome

Improvment of key information about clinical trials, Evaluation of video-recorded consultations, evaluated by blinded rater with a checklist

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Secondary Outcome

1.) Feeling of competence of physicians; questionaire at t0, t1, t2
2.) Understanding of actor patients; questionaire at t0, t1, t2
3.) Understanding of real patients, qualitative study

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2007/08/30
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

physicians in the field of oncology and RCTs

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Exclusion Criteria

physicians from other medical disciplines

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Addresses

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    • Universitätsklinikum Freiburg Abt. Psychosomatische Medizin und Psychotherapie
    • Mr.  Alexander  Wünsch 
    • Hauptstr. 8
    • 79104  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Abt. Psychosomatische Medizin und Psychotherapie
    • Mr.  Alexander  Wünsch 
    • Hauptstr. 8
    • 79104  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Abt. Psychosomatische Medizin und Psychotherapie
    • Mr.  Alexander  Wünsch 
    • Hauptstr. 8
    • 79104  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Roche Pharma AG
    • Postfach 1260
    • 79630  Grenzach-Whylen
    • Germany
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    • Deutsche Krebshilfe German Cancer Aid
    • Buschstr. 32
    • 53004  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2010/05/31
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Trial Publications, Results and other Documents

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