Trial document




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  DRKS00013640

Trial Description

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Title

Oncological Social Care Project of the BKK

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Cancer diseases are potentially life-threating and associated with different medical and psycho-social stress. For this reason, the improving of coping strategies are essential for the patients. The study cohort includes patients with cancer diseases. The participants will be supported by Social Care Nurses for a period of one year. The Social Care Nurses should identify and manage deficits in the health care utilization based on structured interviews. A better patients´s knowledge of its disease can support patients in their choice of therapies with reflection of their own preferences.
The Aim of the study is to improve the quality of life and patients´ autonomy.

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Brief Summary in Scientific Language

The evaluation is a non-randomized, controlled, multi-center study with two modules. Module 1 analyse the improvement of subjective parameters in patient surveys. Modul 2 includes the analysis of secondary data from the statutory health care insurances. A final evaluation of structures, processes und results will investigated with a qualitative analysis of the experiences from the Social Care Nurses.

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Organizational Data

  •   DRKS00013640
  •   2017/12/29
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  •   yes
  •   Approved
  •   EA2/192/17, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   acute leukemia, aggressive lymphoma, bronchial carcinoma, pancreatic carcinoma and colon carcinoma (advanced stage), multiple myeloma and malignant plasma cell neoplasms, metastasized malignant neoplasm of breast, metastasized malignant neoplasm of ovary, metastasized malignant neoplasm of cervix uteri, metastasized malignant neoplasm of corpus uteri, malignant neoplasm of stomach, malignant neoplasm of esophagus, metastasized malignant neoplasms of lip, oral cavity, and pharynx, metastasized malignant neoplasm of prostate, metastasized malignant neoplasm of thyroid gland, metastasized melanoma and other malignant neoplasms of skin
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Interventions/Observational Groups

  •   Intervention Group with 150 patients: Support through 12 structured interviews and specific measures (if necessary) within 1 year
  •   Controll group with 200 patients. No Support from the Social Care Nurse
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The primary aim of this study is to determine changes in the doctor-patient communication, the health literacy and the quality of life in the participating patients. The effects will be measured by repeated interviews within one year.

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Secondary Outcome

The secondary aim is to evaluate the association between health literacy, participation, improved communication and quality of life. In addition, objective outcomes will be measured with secondary data (statutory health insurance) to analyse the effects caused by participants in the program OSCAR (e.g. health care utilization, costs) in comparison to non-participants.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/02/05
  •   350
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

acute leukemia, aggressive lymphoma, bronchial carcinoma, pancreatic carcinoma, colon carcinoma (advanced stage), multiple myeloma and malignant plasma cell neoplasms, metastasized malignant neoplasm of breast, metastasized malignant neoplasm of ovary, metastasized malignant neoplasm of cervix uteri, metastasized malignant neoplasm of corpus uteri, malignant neoplasm of stomach, malignant neoplasm of esophagus, metastasized malignant neoplasms of lip, oral cavity, and pharynx, metastasized malignant neoplasm of prostate, metastasized malignant neoplasm of thyroid gland, metastasized melanoma and other malignant neoplasms of skin

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Exclusion Criteria

advanced dementia, acute addiction

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Addresses

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    • pronova BKK (Konsortialführung)
    • 51373   Leverkusen
    • Germany
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    • Sächsische Krebsgesellschaft e.V.
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    • BKK Dachverband e.V.
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    • Institut für Medizinische Soziologie und RehabilitationswissenschaftCharité - Universitätsmedizin Berlin (Evaluation)
    • Ms.  PD Dr.  Liane  Schenk 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Institut für Medizinische Soziologie und Rehabilitationswissenschaft
    • Mr.  Johann  Frick 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsfonds beim Gemeinsamen Bundesausschuss
    • Wegelystr. 8
    • 10623  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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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.