KOKON Consultation on Complementary Medicine in Oncology - a Pilot Study (KOKON-AS)

August 3, 2015 updated by: Claudia M. Witt, Charite University, Berlin, Germany

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

137

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, 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
      • Heidelberg, Germany
        • Universitätsklinikum Heidelberg, Brustzentrum
      • München, Germany
        • Brustzentrum der LMU München
      • Nürnberg, Germany
        • Brustzentrum Klinikum Nürnberg-Nord
      • Würzburg, Germany
        • Universitätsklinikum Würzburg, Frauenklinik und Poliklinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
day 1-7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 1-7
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.)
day 1-7
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)
day 1-7
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)
day 1-7
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.
day 1-7
Quality of information (patient)
Time Frame: day 1-7
Quality of the information is assessed via questions developed by the study team
day 1-7
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.
day 1-7
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.
day 1-7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Deutsche Krebshilfe e.V., Bonn (Germany)

Investigators

  • Principal Investigator: Claudia M Witt, MD, MBA, Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

July 2, 2014

First Submitted That Met QC Criteria

August 21, 2014

First Posted (Estimate)

August 22, 2014

Study Record Updates

Last Update Posted (Estimate)

August 4, 2015

Last Update Submitted That Met QC Criteria

August 3, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOKON-109863

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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