Trial document




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  DRKS00013649

Trial Description

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Title

Heidelberg Milestone-Communication Approach (Heidelberger Meilenstein-Kommunikationskonzept, HeiMeKOM) - A randomized controlled trial

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Trial Acronym

HeiMeKOM

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URL of the Trial

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Brief Summary in Lay Language

Communication with lung cancer patients with a limited prognosis is perceived to be challenging for all involved in this situation and breaking bad news can be considered one of the most difficult tasks for physicians. Communication about death and dying is often avoided by patients and physicians which results in patients not being fully informed, not receiving enough emotional support and often even receiving more aggressive therapies at end of life. Therefore, a necessity for a better physician-patient-communication exists. According to the National Cancer Plan in Germany, patients should be actively involved in decision-making concerning their treatment, and communication competencies of health care professionals should be improved.
Studies have shown that the integration of palliative care and advance care planning early in the disease trajectory can increase quality of life in patients and caregivers, and even lead to longer survival by improved symptom management and communication regarding coping and end-of-life decision making. Moreover, interprofessional approaches to end-of-life communication show more consistent results.
Therefore, a continuing and interprofessional (meaning: different health care providers work together) communication approach for lung cancer patients with a limited prognosis is planned at the Hospital for Thoracic Diseases, Heidelberg. The implementation and evaluation of the ‘Heidelberg Milestone-Communication Approach’ (HeiMeKOM) is being developed. The implementation plan comprises of different interventions. One of them is the theoretical development and implementation of the Milestone-Communication concept which will be carried out by an interprofessional tandem consisting of a nurse and a physician. At four pivotal consultation moments within the disease trajectory in lung cancer patients, structured consultations between the interprofessional tandem and lung cancer patients and their relatives will be undertaken. These four consultation moments are: 1.) Diagnosis and Prognosis, 2.) Stable phase in the course of treatment, 3.) Progression of the disease, 4.) Transition to best supportive care.
The effect of the HeiMeKOM-project will be investigated using a so-called randomized,controlles trial. We hypothesize that HeiMeKOM will foster communication about prognosis and end-of-life decision making, improve patient Quality of Life and decrease aggressive medical care by the use of guideline-concordant palliative care.

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Brief Summary in Scientific Language

Communication with lung cancer patients with a limited prognosis is perceived to be challenging for all involved in this situation and breaking bad news can be considered one of the most difficult tasks for physicians. Communication about death and dying is often avoided by patients and physicians which results in patients not being fully informed, not receiving enough emotional support and often even receiving more aggressive therapies at end of life. Therefore, a necessity for a better physician-patient-communication exists. According to the National Cancer Plan in Germany, patients should be actively involved in decision-making concerning their treatment, and communication competencies of health care professionals should be improved.
Studies have shown that the integration of palliative care and advance care planning early in the disease trajectory can increase quality of life in patients and caregivers, and even lead to longer survival by improved symptom management and communication regarding coping and end-of-life decision making. Moreover, interprofessional approaches to end-of-life communication show more consistent results.
Therefore, a longitudinal and interprofessional communication approach for lung cancer patients with a limited prognosis is planned at the Hospital for Thoracic Diseases, Heidelberg. The implementation and evaluation of the ‘Heidelberg Milestone-Communication Approach’ (HeiMeKOM) is being developed.
The HeiMeKOM-project consists of three phases: development, implementation and evaluation of the HeiMeKOM-concept. In the first phase the concept was further developed by integrating perceived barriers and facilitators to implementation by physicians and nurses working at the Hospital for Thoracic Diseases, Heidelberg. These were collected using individual and group interviews.
The second phase comprises of an interprofessional communication training for physicians and nurses, who will be performing the so-called Milestone-Consultations in an interprofessional tandem with patients and their relatives in future at four pivotal consultation moments within the disease trajectory in lung cancer patients. These four consultation moments are: 1.) Diagnosis and Prognosis, 2.) Stable phase in the course of treatment, 3.) Progression of the disease, 4.) Transition to best supportive care.
In the third phase the effects of the HeiMeKOM-project will be evaluated using a randomized controlled approach. The primary outcome of the study are the effects on the dimension “Health system/ Information” of the Short Form of the Supportive Care Needs Survey (SCNS-SF-34). We hypothesize that HeiMeKOM will foster communication about prognosis and end-of-life decision making, improve patient Quality of Life and decrease aggressive medical care by the use of guideline-concordant palliative care.
Due to the high drop-out rate, an adjustment of the study design is conducted. Instead of the originally planned 100 study participants, we now aim at 190 participants (Amendment S-561/2017, approved on February 12, 2019)

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Organizational Data

  •   DRKS00013649
  •   2017/12/22
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  •   yes
  •   Approved
  •   S-561/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   C30-C39 -  Malignant neoplasms of respiratory and intrathoracic organs
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Interventions/Observational Groups

  •   Physician-patient-communication as usual
  •   Physician-patient-communication as described in the HeiMeKOM-communication-concept:
    - Structured communication at four pivotal consultation moments in disease trajectory by an interprofessional tandem consisting of a nurse and a physician who have received a communication training in advance
    - Aim: enhance advance care planning and integration of early palliative care
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome of the study are the effects on the dimension “Health system/ Information” of the Short Form of the Supportive Care Needs Survey (SCNS-SF-34).

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Secondary Outcome

Secondary outcomes:
Supportive care needs: SCNS-SF34-G (for patients), SCNS-SF34-P&C-G (for relatives), in the HeiMeKOM-group: IPOS (Integrated Palliative Care Outcome Scale)

Quality of Life: SEIQoL-Q, FACT-G, FACT-L, PHQ-4

Patient Distress: Distress-Thermometer

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/05/01
  •   190
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Phase 3 (outcome evaluation)
Randomized controlled trial with patients:
-Patients: requirements for milestone-consultations fulfilled (newly diagnosed incurable lung cancer (stage IV)), 18 years and older, capability to give consent, good knowledge of German language, willingness to participate in study
-Relatives of patients: 18 years and older, capability to give consent, good knowledge of German language, willingness to participate in study

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Exclusion Criteria

-Patient does not speak German
-Patient is in a medical condition (e.g. acute life-threatening condition), which does not allow consultations

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Addresses

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    • Thoraxklinik Heidelberg gGmbH
    • Mr.  Matthias  Villalobos 
    • Röntgenstraße 1
    • 69126  Heidelberg
    • Germany
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    • Abteilung Allgemeinmedizin und Versorgungsforschung, Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr.  Michel  Wensing 
    • Im Neuenheimer Feld 130.3, Marsilius-Arkaden, Turm West
    • 69120  Heidelberg
    • Germany
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    • Institut für medizinische und pharmazeutische Prüfungsfragen
    • Ms.  Prof. Dr. med.  Jana  Jünger 
    • Große Langgasse 8
    • 55116  Mainz
    • Germany
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    • Thoraxklinik Heidelberg gGmbH
    • Mr.  Matthias  Villalobos 
    • Röntgenstraße 1
    • 69126  Heidelberg
    • Germany
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    • Thoraxklinik Heidelberg gGmbH
    • Ms.  Dr.   Corinna   Jung 
    • Röntgenstraße 1
    • 69126  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • BundesverwaltungsamtZuwendungsmanagement Verwaltungs- und Ordnungsaufgaben, Referat ZMV 1, Grundsatzangelegenheiten ZMV 1, ESF Bescheinigungsstelle, Zuwendungen im Bereich BMG
    • Ms.  Hildegard  Bongartz 
    • Eupener Straße 125
    • 50933  Köln
    • Germany
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    •   022899 358 5233
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    • Nationales Centrum für Tumorerkrankungen Heidelberg (NCT)
    • Im Neuenheimer Feld 460
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.