KOKON Consultation on Complementary Medicine in Oncology - a Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Breast-cancer

Intervention / Treatment
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* Behavioral: Consultation by a trained physician
* Behavioral: Consultation by an untrained physician


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Consultation by a trained physician<br>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<br> <br> |
| Active Comparator: Consultation by an untrained physician<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the training program | 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) | Questions regarding different topics relating to complementary medicine in oncology and consultations of oncology patients | day 1-7 | 
| Evaluation of each consultation session (physicians) | Evaluation of the consultation session by the physicians (e.g. time spent on the consultation, difficulties, empathy etc.) | day 1-7 | 
| Empathy: CARE (patient) | Empathy is assessed via an adaption of the German version of the Consultation and Relational Empathy scale (CARE) | day 1-7 | 
| Empathy: REM (patient) | 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) | Satisfaction with the consultation session is assessed via questions developed by the study team. | day 1-7 | 
| Quality of information (patient) | Quality of the information is assessed via questions developed by the study team | day 1-7 | 
| Qualitative analysis of focus groups (physicians) | 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 | In each group (consulations by trained and by untrained physicians) 8 consultation sessions will be videotaped and analyzed with qualitative methods. | day 1-7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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complementary therapies, consultants, medical oncology, breast-cancer, education