KOKON Consultation on Complementary Medicine in Oncology - a Pilot Study

Breast-cancer Clinical Trial

— KOKON-AS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02223091
• Other study ID #: KOKON-109863
• Status: Completed
• Phase: N/A
• First received: July 2, 2014
• Last updated: August 3, 2015
• Start date: September 2014
• Est. completion date: March 2015

Study information

• Verified date: August 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for physicians:

• age >18 years

• working in a breast center of comprehensive cancer center

• able to consult 10 patients within working hours

• training group: able to participate in on-site-training

• not primarily treating the patients that are consulted

• good language skills (for consultations)

• informed consent

Inclusion Criteria for patients:

• age > 18 years

• female

• diagnosis of breast-cancer

• patient in the participating center

• good language skills (for consultations)

• informed consent

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Breast-cancer

Intervention

Behavioral:
• Consultation by a trained physician

• Consultation by an untrained physician

Locations

Country	Name	City	State
Germany	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

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Deutsche Krebshilfe e.V., Bonn (Germany)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of the training program	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.	day 1-7	No
Secondary	Knowledge about complementary medicine in oncology and consultations (physicians)	Questions regarding different topics relating to complementary medicine in oncology and consultations of oncology patients	day 1-7	No
Secondary	Evaluation of each consultation session (physicians)	Evaluation of the consultation session by the physicians (e.g. time spent on the consultation, difficulties, empathy etc.)	day 1-7	No
Secondary	Empathy: CARE (patient)	Empathy is assessed via an adaption of the German version of the Consultation and Relational Empathy scale (CARE)	day 1-7	No
Secondary	Empathy: REM (patient)	Empathy is assessed via an adapted version of the Rating Scales for the Assessment of Empathic Communication in Medical Interviews (REM)	day 1-7	No
Secondary	Satisfaction with the consultation session (patient)	Satisfaction with the consultation session is assessed via questions developed by the study team.	day 1-7	No
Secondary	Quality of information (patient)	Quality of the information is assessed via questions developed by the study team	day 1-7	No
Secondary	Qualitative analysis of focus groups (physicians)	Focus groups will be conducted with each group of physicians (trained and untrained). They will be analyzed using qualitative methods.	day 1-7	No
Secondary	Qualitative analysis of videotapings of consultation sessions	In each group (consulations by trained and by untrained physicians) 8 consultation sessions will be videotaped and analyzed with qualitative methods.	day 1-7	No