Breast-cancerKOKON-ASNCT02223091
KOKON Consultation on Complementary Medicine in Oncology - a Pilot Study
A study testing Consultation by a trained physician and Consultation by an untrained physician in people with Breast-cancer, run by Charite University, Berlin, Germany at 8 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast-cancer
- What is being tested?
- Consultation by a trained physician and Consultation by an untrained physician
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 8 sitesGermany
- Study dates
- Sep 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 13Show fewer
- informed consent
- age > 18 years
- female
- diagnosis of breast-cancer
- patient in the participating center
- good language skills (for consultations)
- informed consent
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Brustzentrum am Vivantes Klinikum am Urban
Berlin
Brustzentrum im Sana-Klinikum Lichtenberg
Berlin
Brustzentrum, Klinik für Gynäkologie, Charité, Campus Mitte
Berlin
DRK Kliniken Westend, Brustzentrum
Berlin
Universitätsklinikum Heidelberg, Brustzentrum
Heidelberg
Brustzentrum der LMU München
München
Brustzentrum Klinikum Nürnberg-Nord
Nuremberg
Universitätsklinikum Würzburg, Frauenklinik und Poliklinik
Würzburg
About this study
Official 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)
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.
- Conditions
- Breast-cancer
- Being tested
- Consultation by a trained physician, Consultation by an untrained physician
- Keywords
- complementary therapies, consultants, medical oncology, breast-cancer, education
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consultation by a trained physicianBehavioural
Consultation by an untrained physicianBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Consultation by an untrained physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1-7
Secondary outcomes (8)
Knowledge about complementary medicine in oncology and consultations (physicians)
Questions regarding different topics relating to complementary medicine in oncology and consultations of oncology patients
Measured: 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.)
Measured: day 1-7
Empathy: CARE (patient)
Empathy is assessed via an adaption of the German version of the Consultation and Relational Empathy scale (CARE)
Measured: 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)
Measured: day 1-7
Satisfaction with the consultation session (patient)
Satisfaction with the consultation session is assessed via questions developed by the study team.
Measured: day 1-7
Quality of information (patient)
Quality of the information is assessed via questions developed by the study team
Measured: 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.
Measured: 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.
Measured: day 1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast-cancerStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany)
- Responsible party
- Principal investigator, Claudia M. Witt, Charite University, Berlin, Germany
- Investigators
- Claudia M Witt, MD, MBA, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223091
- Sponsor's protocol ID
- KOKON-109863
- Acronym
- KOKON-AS
- Status last verified
- Aug 2015
- First submitted
- 2 Jul 2014
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27809814
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT02223091
- Acronym / sponsor ID
- KOKON-AS / KOKON-109863
- Conditions
- Breast-cancer
- Keywords
- complementary therapies, consultants, medical oncology, breast-cancer, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany)
- Study start
- Sep 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Consultation by a trained physician | Experimental | Behavioral: Consultation by a trained physicianThe 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. |
| Consultation by an untrained physician | Active comparator | Behavioral: Consultation by an untrained physicianThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Consultation by a trained physician | Behavioural | Consultation by a trained physician |
| Consultation by an untrained physician | Behavioural | Consultation by an untrained physician |
Primary outcome
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.
8 secondary outcomes
Knowledge about complementary medicine in oncology and consultations (physicians)
Time frame: day 1-7
Evaluation of each consultation session (physicians)
Time frame: day 1-7
Empathy: CARE (patient)
Time frame: day 1-7
Empathy: REM (patient)
Time frame: day 1-7
Satisfaction with the consultation session (patient)
Time frame: day 1-7
Quality of information (patient)
Time frame: day 1-7
Qualitative analysis of focus groups (physicians)
Time frame: day 1-7
Qualitative analysis of videotapings of consultation sessions
Time frame: day 1-7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
- Derived from this study: PubMed 27809814Blodt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia M Witt, MD, MBA principal investigator
Charite University, Berlin, Germany
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consultation by a trained physician and Consultation by an untrained physician in people with Breast-cancer, run by Charite University, Berlin, Germany at 8 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the training program (time frame: day 1-7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02223091, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2015.