KOKON Consultation on Complementary Medicine in Oncology - a Pilot Study

NCT ID: NCT02223091

Last Updated: 2015-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-03-31

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.

Detailed Description

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Conditions

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Breast-cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Consultation by a trained physician

Intervention Type 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.

Group Type ACTIVE_COMPARATOR

Consultation by an untrained physician

Intervention Type BEHAVIORAL

Interventions

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Consultation by a trained physician

Intervention Type BEHAVIORAL

Consultation by an untrained physician

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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


* age \> 18 years
* female
* diagnosis of breast-cancer
* patient in the participating center
* good language skills (for consultations)
* informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsche Krebshilfe e.V., Bonn (Germany)

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Claudia M. Witt

Prof. Dr. Claudia M. Witt, MBA

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia M Witt, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Brustzentrum am Vivantes Klinikum am Urban

Berlin, , Germany

Site Status

Brustzentrum im Sana-Klinikum Lichtenberg

Berlin, , Germany

Site Status

Brustzentrum, Klinik für Gynäkologie, Charité, Campus Mitte

Berlin, , Germany

Site Status

DRK Kliniken Westend, Brustzentrum

Berlin, , Germany

Site Status

Universitätsklinikum Heidelberg, Brustzentrum

Heidelberg, , Germany

Site Status

Brustzentrum der LMU München

München, , Germany

Site Status

Brustzentrum Klinikum Nürnberg-Nord

Nuremberg, , Germany

Site Status

Universitätsklinikum Würzburg, Frauenklinik und Poliklinik

Würzburg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 27809814 (View on PubMed)

Other Identifiers

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KOKON-109863

Identifier Type: -

Identifier Source: org_study_id

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