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Completed

NCT Number: NCT02223091

KOKON Consultation on Complementary Medicine in Oncology - a Pilot Study

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.

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Key information

Conditions

Breast-cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brustzentrum am Vivantes Klinikum am Urban, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Consultation by a trained physician

Behavioral

Consultation by an untrained physician

Behavioral

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Deutsche Krebshilfe e.V., Bonn (Germany)

Registry information

Official study 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)

Acronym: KOKON-AS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 22, 2014
Registry last updated
Aug 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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