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
-
-
-
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.
|
|
|
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.
|
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.
Collaborators
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.
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
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.