NCT02223091

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

August 4, 2015

Status Verified

August 1, 2015

Enrollment Period

5 months

First QC Date

July 2, 2014

Last Update Submit

August 3, 2015

Conditions

Breast-cancer

Keywords

complementary therapiesconsultantsmedical oncologybreast-cancereducation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Consultation by a trained physician

EXPERIMENTAL

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

Consultation by an untrained physician

ACTIVE COMPARATOR

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

Interventions

Consultation by a trained physicianBEHAVIORAL
Consultation by a trained physician
Consultation by an untrained physicianBEHAVIORAL
Consultation by an untrained physician

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Brustzentrum am Vivantes Klinikum am Urban

Berlin, Germany

Location

Brustzentrum im Sana-Klinikum Lichtenberg

Berlin, Germany

Location

Brustzentrum, Klinik für Gynäkologie, Charité, Campus Mitte

Berlin, Germany

Location

DRK Kliniken Westend, Brustzentrum

Berlin, Germany

Location

Universitätsklinikum Heidelberg, Brustzentrum

Heidelberg, Germany

Location

Brustzentrum der LMU München

München, Germany

Location

Brustzentrum Klinikum Nürnberg-Nord

Nuremberg, Germany

Location

Universitätsklinikum Würzburg, Frauenklinik und Poliklinik

Würzburg, Germany

Location

Related Publications (1)

  • 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.

    PMID: 27809814DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Claudia M Witt, MD, MBA

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Claudia M. Witt, MBA

Study Record Dates

First Submitted

July 2, 2014

First Posted

August 22, 2014

Study Start

September 1, 2014

Primary Completion

February 1, 2015

Study Completion

March 1, 2015

Last Updated

August 4, 2015

Record last verified: 2015-08

Locations

DE(8)