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KOKON Consultation on Complementary Medicine in Oncology - a Pilot Study

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02223091
Acronym
KOKON-AS
Enrollment
137
Registered
2014-08-22
Start date
2014-09-30
Completion date
2015-03-31
Last updated
2015-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast-cancer

Keywords

complementary therapies, consultants, medical oncology, breast-cancer, education

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.

Interventions

BEHAVIORALConsultation by a trained physician
BEHAVIORALConsultation by an untrained physician

Sponsors

Deutsche Krebshilfe e.V., Bonn (Germany)
CollaboratorOTHER
Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of the training programday 1-7This 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

MeasureTime frameDescription
Evaluation of each consultation session (physicians)day 1-7Evaluation of the consultation session by the physicians (e.g. time spent on the consultation, difficulties, empathy etc.)
Empathy: CARE (patient)day 1-7Empathy is assessed via an adaption of the German version of the Consultation and Relational Empathy scale (CARE)
Empathy: REM (patient)day 1-7Empathy is assessed via an adapted version of the Rating Scales for the Assessment of Empathic Communication in Medical Interviews (REM)
Knowledge about complementary medicine in oncology and consultations (physicians)day 1-7Questions regarding different topics relating to complementary medicine in oncology and consultations of oncology patients
Quality of information (patient)day 1-7Quality of the information is assessed via questions developed by the study team
Qualitative analysis of focus groups (physicians)day 1-7Focus 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 1-7In each group (consulations by trained and by untrained physicians) 8 consultation sessions will be videotaped and analyzed with qualitative methods.
Satisfaction with the consultation session (patient)day 1-7Satisfaction with the consultation session is assessed via questions developed by the study team.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026