ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02223091
Recruitment Status : Completed
First Posted : August 22, 2014
Last Update Posted : August 4, 2015
Sponsor:
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
Claudia M. Witt, 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.

Condition or disease Intervention/treatment Phase
Breast-cancer Behavioral: Consultation by a trained physician Behavioral: Consultation by an untrained physician Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
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)
Study Start Date : September 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.)

  3. 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)

  4. 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)

  5. 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.

  6. Quality of information (patient) [ Time Frame: day 1-7 ]
    Quality of the information is assessed via questions developed by the study team

  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.

  8. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223091


Locations
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, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
Deutsche Krebshilfe e.V., Bonn (Germany)
Investigators
Principal Investigator: Claudia M Witt, MD, MBA Charite University, Berlin, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Claudia M. Witt, Prof. Dr. Claudia M. Witt, MBA, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02223091     History of Changes
Other Study ID Numbers: KOKON-109863
First Posted: August 22, 2014    Key Record Dates
Last Update Posted: August 4, 2015
Last Verified: August 2015

Keywords provided by Claudia M. Witt, Charite University, Berlin, Germany:
complementary therapies
consultants
medical oncology
breast-cancer
education