Clinical trial NCT02223091: KOKON Consultation on Complementary Medicine in Oncology - a Pilot Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast-cancer
Keywords: complementary therapies
consultants
medical oncology
breast-cancer
education
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Deutsche Krebshilfe e.V., Bonn (Germany)
First posted: 2014-08-22
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Effectiveness of the training program
timeFrame: day 1-7
Secondary outcomes:
measure: Knowledge about complementary medicine in oncology and consultations (physicians)
timeFrame: day 1-7
measure: Evaluation of each consultation session (physicians)
timeFrame: day 1-7
measure: Empathy: CARE (patient)
timeFrame: day 1-7
measure: Empathy: REM (patient)
timeFrame: day 1-7
measure: Satisfaction with the consultation session (patient)
timeFrame: day 1-7
measure: Quality of information (patient)
timeFrame: day 1-7
measure: Qualitative analysis of focus groups (physicians)
timeFrame: day 1-7
measure: Qualitative analysis of videotapings of consultation sessions
timeFrame: day 1-7
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Brustzentrum am Vivantes Klinikum am Urban
city: Berlin
country: Germany
facility: Brustzentrum im Sana-Klinikum Lichtenberg
city: Berlin
country: Germany
facility: Brustzentrum, Klinik für Gynäkologie, Charité, Campus Mitte
city: Berlin
country: Germany
facility: DRK Kliniken Westend, Brustzentrum
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg, Brustzentrum
city: München
country: Germany
facility: Brustzentrum der LMU München
city: Nürnberg
country: Germany
facility: Brustzentrum Klinikum Nürnberg-Nord
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg, Frauenklinik und Poliklinik
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia M Witt, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blodt S, Mittring N, Schutzler L, Fischer F, Holmberg C, Horneber M, Stapf A, Witt CM. A consultation training program for physicians for communication about complementary medicine with breast cancer patients: a prospective, multi-center, cluster-randomized, mixed-method pilot study. BMC Cancer. 2016 Nov 4;16(1):843. doi: 10.1186/s12885-016-2884-y.