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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 137
- Locations
- 8
- Primary Endpoint
- Effectiveness of the training program
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •diagnosis of breast-cancer
- •patient in the participating center
- •good language skills (for consultations)
- •informed consent
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Consultation by a trained physician (Behavioral)
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.
Intervention: Consultation by an untrained physician (Behavioral)
Outcomes
Primary Outcomes
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 Outcomes
- Knowledge about complementary medicine in oncology and consultations (physicians)(day 1-7)
- Evaluation of each consultation session (physicians)(day 1-7)
- Empathy: CARE (patient)(day 1-7)
- Empathy: REM (patient)(day 1-7)
- Satisfaction with the consultation session (patient)(day 1-7)
- Quality of information (patient)(day 1-7)
- Qualitative analysis of focus groups (physicians)(day 1-7)
- Qualitative analysis of videotapings of consultation sessions(day 1-7)
Investigators
Claudia M. Witt
Prof. Dr. Claudia M. Witt, MBA
Charite University, Berlin, Germany