KOKON Consultation on Complementary Medicine in Oncology - a Pilot Study

Not Applicable

Completed

• Conditions: Breast-cancer

• Registration Number: NCT02223091
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

The aim of the study is to investigate the effect of a consultation training program for physicians on the quality of their consultations of breast cancer patients regarding complementary medicine. We assume that the training program might enhance the communication of relevant information, empathy of the physicians or satisfaction with the consultation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-08-21
• Study First Posted: 2014-08-22
• Study Start: 2014-09
• Primary Completion: 2015-02
• Study Completion: 2015-03
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-03
• Last Update Posted: 2015-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Effectiveness of the training program	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.

Secondary Outcome Measures

Name	Time	Method
Knowledge about complementary medicine in oncology and consultations (physicians)	day 1-7	Questions regarding different topics relating to complementary medicine in oncology and consultations of oncology patients
Evaluation of each consultation session (physicians)	day 1-7	Evaluation of the consultation session by the physicians (e.g. time spent on the consultation, difficulties, empathy etc.)
Empathy: CARE (patient)	day 1-7	Empathy is assessed via an adaption of the German version of the Consultation and Relational Empathy scale (CARE)
Empathy: REM (patient)	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)	day 1-7	Satisfaction with the consultation session is assessed via questions developed by the study team.
Quality of information (patient)	day 1-7	Quality of the information is assessed via questions developed by the study team
Qualitative analysis of focus groups (physicians)	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	day 1-7	In each group (consulations by trained and by untrained physicians) 8 consultation sessions will be videotaped and analyzed with qualitative methods.

Trial Locations

Locations (8)

Brustzentrum am Vivantes Klinikum am Urban; 🇩🇪 Berlin, Germany

Brustzentrum im Sana-Klinikum Lichtenberg; 🇩🇪 Berlin, Germany

Brustzentrum, Klinik für Gynäkologie, Charité, Campus Mitte; 🇩🇪 Berlin, Germany

DRK Kliniken Westend, Brustzentrum; 🇩🇪 Berlin, Germany

Universitätsklinikum Heidelberg, Brustzentrum; 🇩🇪 Heidelberg, Germany

Brustzentrum der LMU München; 🇩🇪 München, Germany

Brustzentrum Klinikum Nürnberg-Nord; 🇩🇪 Nürnberg, Germany

Universitätsklinikum Würzburg, Frauenklinik und Poliklinik; 🇩🇪 Würzburg, Germany