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KOKON Consultation on Complementary Medicine in Oncology - a Pilot Study

Not Applicable
Completed
Conditions
Breast-cancer
Interventions
Behavioral: Consultation by an untrained physician
Behavioral: Consultation by a trained physician
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

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
Arm && Interventions
GroupInterventionDescription
Consultation by an untrained physicianConsultation by an untrained physicianThe 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.
Consultation by a trained physicianConsultation by a trained physicianThe 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.
Primary Outcome Measures
NameTimeMethod
Effectiveness of the training programday 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
NameTimeMethod
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 sessionsday 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)

Universitätsklinikum Würzburg, Frauenklinik und Poliklinik

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Würzburg, Germany

Brustzentrum am Vivantes Klinikum am Urban

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Berlin, Germany

Universitätsklinikum Heidelberg, Brustzentrum

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Heidelberg, Germany

Brustzentrum Klinikum Nürnberg-Nord

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Nürnberg, Germany

Brustzentrum im Sana-Klinikum Lichtenberg

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Berlin, Germany

Brustzentrum der LMU München

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München, Germany

Brustzentrum, Klinik für Gynäkologie, Charité, Campus Mitte

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Berlin, Germany

DRK Kliniken Westend, Brustzentrum

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Berlin, Germany

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