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Network Oncology - therapy accompanying evaluation of health services research in integrative oncolgy

Organizational Data

DRKS-ID:
DRKS00013335
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2017-11-27
Last update in DRKS:
2022-10-18
Registration type:
Retrospective

Acronym/abbreviation of the study

Network Oncology

URL of the study

No Entry

Brief summary in lay language

Evaluation of integrative therapeutical concepts (linkage of modern oncology care with anthroposophic additional therapies, e.g. mistletoe therapy, psycho-oncological support) in oncology in health services research. Inclusion of tumor patients who gave written consent (18-100 years old). The aim of the study is the development of a clinical register according to standards of tumor basis documentation and which reflects real world treatment. This registry will be expanded by the documentation of additional non-pharmacological interventions (NPI) and mistletoe (VA, Viscum album L.) treatment. In addition, health related quality of life of patients will be measured. The long-term goal is the qualitative improvement of oncological patient care and the integration of findings obtained into health services research.

Brief summary in scientific language

Epidemiological oncological observational study without intervention for the evaluation of integrative oncological therapy concepts in health services research. All oncological patients aged between 18 and 100 years and from which written informed consent has been obtained will be included in the study. Primary aim: The aim of the study is the development of a clinical register according to standards of the working group of German Tumour Centres (Arbeitsgemeinschaft Deutscher Tumorzentren e.V. - ADT) and which reflects real world treatment. This registry will be expanded by the documentation of additional non-pharmacological interventions (NPI) and mistletoe (VA, Viscum album L.) treatment. Realisation: - Development of tumor basis documentation at the sites of relevant network partners and analysis of further development and application of research instruments and methods in health services research - Receival of safety data through documentation of adverse events of applied therapies - Description and analysis of health service research data and supply structures with the help of qualitative methods and qualitative-empirical analyses for the generation of hypotheses. - Theoretical conclusion: Determination of scope of hypotheses gained and, if appropriate, analysis and assessment of generalizations and derivation of causality with existing theories. - In addition, the incidence of respiratory infections will be studied - Additionally, survival of cancer patients will be studied - Additionally, cost-utility analyses (EQ-5D) will be performed - In addition, the quality of life (EORTC QLQ-C30, CFS-D, ICS, NCCN Distress Thermometer, Midos questionnaire) of the studied patients will be measured at different time points The long-term goal is the qualitative improvement of oncological patient care and the integration of findings obtained into health services research. The linkage of modern medical patient care, anthroposophic additional interventions and psycho-oncological care as an integrative therapeutic concept will be for the first time systematically documented with the help of psychometric inventories.

Health condition or problem studied

ICD10:
C50 - Malignant neoplasm of breast
ICD10:
C34 - Malignant neoplasm of bronchus and lung
ICD10:
C20 - Malignant neoplasm of rectum
ICD10:
C18 - Malignant neoplasm of colon
ICD10:
C19 - Malignant neoplasm of rectosigmoid junction
ICD10:
C15 - Malignant neoplasm of oesophagus
ICD10:
C16 - Malignant neoplasm of stomach
ICD10:
C22 - Malignant neoplasm of liver and intrahepatic bile ducts
ICD10:
C24 - Malignant neoplasm of other and unspecified parts of biliary tract
ICD10:
C26 - Malignant neoplasm of other and ill-defined digestive organs
ICD10:
C75 - Malignant neoplasm of other endocrine glands and related structures
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Epidemiological oncological observational study without intervention for the evaluation of integrative oncological therapy concepts in health services research. All oncological patients aged between 18 and 100 years and from which written informed consent has been obtained will be included in the study. Primary aim: The aim of the study is the development of a clinical register according to standards of the working group of German Tumour Centres (Arbeitsgemeinschaft Deutscher Tumorzentren e.V. - ADT) and which reflects real world treatment. This registry will be expanded by the documentation of additional non-pharmacological interventions (NPI) and mistletoe (VA, Viscum album L.) treatment. Realisation: - Development of tumor basis documentation at the sites of relevant network partners and analysis of further development and application of research instruments and methods in health services research - Receival of safety data through documentation of adverse events of applied therapies - Description and analysis of health service research data and supply structures with the help of qualitative methods and qualitative-empirical analyses for the generation of hypotheses. - In addition, the incidence of respiratory infections will be studied - Additionally, survival of cancer patients will be studied - Additionally, cost-utility analyses (EQ-5D) will be performed - In addition, the quality of life (EORTC QLQ-C30, CFS-D, ICS, NCCN Distress Thermometer, Midos questionnaire) of the studied patients will be measured at different time points The long-term goal is the qualitative improvement of oncological patient care and the integration of findings obtained into health services research. The linkage of modern medical patient care, anthroposophic additional interventions and psycho-oncological care as an integrative therapeutic concept will be for the first time systematically documented with the help of psychometric inventories.

Endpoints

Primary outcome:
Systematic documentation of all oncological therapies under consideration of all treatment remedies and application of integrative therapeutic concepts on the basis of patient files for the illustration of health services research until January, 31st, 2032.
Secondary outcome:
Comparative analyses of treatment patterns of applied therapies

Study Design

Purpose:
Other
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Medical center Gemeinschaftskrankenhaus Herdecke Herdecke
  • Medical center Reha-Klinik Schloss Hamborn Borchen
  • Other Medizinisches Versorgungszentrum Havelhöhe Berlin
  • Medical center KLINIK ÖSCHELBRONN GEMEINNÜTZIGE GMBH
  • Doctor's practice Gevelsberg
  • Other Klinikambulanz HerdeckeInternistische onkologische Schwerpunktpraxis Herdecke
  • Medical center Gemeinschaftskrankenhaus Havelhöhe Berlin
  • Doctor's practice Berlin
  • Doctor's practice Niefern-Öschelbronn
  • Medical center Klinikum Passau Passau
  • Medical center Städtisches Klinikum Brandenburg, Hochschulklinikum der MHB Brandenburg an der Havel
  • Medical center Klinikum Altenburger Land GmbH Altenburg
  • Medical center Klinikum Bad Hersfeld Bad Hersfeld
  • Medical center St. Elisabeth Krankenhaus gGmbH Löörach
  • Medical center Kliniken des Landkreises Lörrach GmbH Lörrach
  • Medical center Bethanien Krankenhaus Frankfurt, Darmzentrum, Centrum für Hämatologie und Onkologie Bethanien Frankfurt a.M.

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2011-02-05
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
14000
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
100 Years
Additional Inclusion Criteria:
Written informed consent. Cancer, see chapter health condition/ disease studies.

Exclusion Criteria

none

Addresses

Primary Sponsor

Forschungsinstitut Havelhöhe (FIH) gGmbH am Gemeinschaftskrankenhaus Havelhöhe
Kladower Damm
14089 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Forschungsinstitut Havelhöhe (FIH) gGmbH am Gemeinschaftskrankenhaus Havelhöhe
Dr. Friedemann Schad
Kladower Damm 221
14089 Berlin
Germany
Telephone:
03036501456
Fax:
0303650279
Contact per E-Mail
URL:
http://www.fih-berlin.de/

Contact for Public Queries

Forschungsinstitut Havelhöhe (FIH) gGmbH am Gemeinschaftskrankenhaus Havelhöhe
Antje Merkle
Kladower Damm 221
14089 Berlin
Germany
Telephone:
03036501626
Fax:
03036501188
Contact per E-Mail
URL:
http://www.fih-berlin.de/

Principal Investigator

Forschungsinstitut Havelhöhe (FIH) gGmbH am Gemeinschaftskrankenhaus Havelhöhe
Dr. Friedemann Schad
Kladower Damm 221
14089 Berlin
Germany
Telephone:
03036501456
Fax:
0303650279
Contact per E-Mail
URL:
http://www.fih-berlin.de/

Sources of Monetary or Material Support

Private sponsorship (foundations, study societies, etc.)

Forschungsinstitut Havelhöhe (FIH) gGmbH am Gemeinschaftskrankenhaus Havelhöhe
Kladower Damm 221
14089 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Ärztekammer Berlin
Friedrichstraße 16
10696 Berlin
Germany
Telephone:
(+49)30-408062601
Fax:
(+49)30-408062298
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2010-11-03
Ethics committee number:
Eth-27/10
Vote of the Ethics Committee:
Approved
Date of the vote:
2011-02-05

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry