KOKON Consultation on Complementary Medicine in Oncology - a Pilot Study (KOKON-AS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02223091|
Recruitment Status : Completed
First Posted : August 22, 2014
Last Update Posted : August 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Breast-cancer||Behavioral: Consultation by a trained physician Behavioral: Consultation by an untrained physician||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||137 participants|
|Intervention Model:||Single Group Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Prospective, Multi-center, Cluster-randomized, Pragmatic, Mixed-method Pilot Study Evaluating a Consultation Training Program for Physicians Within the Framework of KOKON (Competence Network Complementary Medicine in Oncology)|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||March 2015|
Experimental: Consultation by a trained physician
The physicians of this group receive a free consultation training program on skills regarding consultations on complementary medicine for breast-cancer patients. The training was developed by a multi-professional team and is comprised of three parts: (1) online-training, (2) on-site-training, and (3) consultation manual. Each of the physicians will counsel 10 patients. The patients in this group therefore receive a consultation by a trained physician.
Behavioral: Consultation by a trained physician
Active Comparator: Consultation by an untrained physician
The physicians of the control arm receive no training. Each will counsel 10 patients. The patients in this group therefore receive a consultation by an untrained physician.
Behavioral: Consultation by an untrained physician
- Effectiveness of the training program [ Time Frame: day 1-7 ]This is an exploratory study. The main aim is to evaluate the effectiveness of the training program which will be achieved using the different outcome measures defined here as secondary outcome measures.
- Knowledge about complementary medicine in oncology and consultations (physicians) [ Time Frame: day 1-7 ]Questions regarding different topics relating to complementary medicine in oncology and consultations of oncology patients
- Evaluation of each consultation session (physicians) [ Time Frame: day 1-7 ]Evaluation of the consultation session by the physicians (e.g. time spent on the consultation, difficulties, empathy etc.)
- Empathy: CARE (patient) [ Time Frame: day 1-7 ]Empathy is assessed via an adaption of the German version of the Consultation and Relational Empathy scale (CARE)
- Empathy: REM (patient) [ Time Frame: day 1-7 ]Empathy is assessed via an adapted version of the Rating Scales for the Assessment of Empathic Communication in Medical Interviews (REM)
- Satisfaction with the consultation session (patient) [ Time Frame: day 1-7 ]Satisfaction with the consultation session is assessed via questions developed by the study team.
- Quality of information (patient) [ Time Frame: day 1-7 ]Quality of the information is assessed via questions developed by the study team
- Qualitative analysis of focus groups (physicians) [ Time Frame: day 1-7 ]Focus groups will be conducted with each group of physicians (trained and untrained). They will be analyzed using qualitative methods.
- Qualitative analysis of videotapings of consultation sessions [ Time Frame: day 1-7 ]In each group (consulations by trained and by untrained physicians) 8 consultation sessions will be videotaped and analyzed with qualitative methods.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223091
|Brustzentrum am Vivantes Klinikum am Urban|
|Brustzentrum im Sana-Klinikum Lichtenberg|
|Brustzentrum, Klinik für Gynäkologie, Charité, Campus Mitte|
|DRK Kliniken Westend, Brustzentrum|
|Universitätsklinikum Heidelberg, Brustzentrum|
|Brustzentrum der LMU München|
|Brustzentrum Klinikum Nürnberg-Nord|
|Universitätsklinikum Würzburg, Frauenklinik und Poliklinik|
|Principal Investigator:||Claudia M Witt, MD, MBA||Charite University, Berlin, Germany|