Trial document
DRKS00013640
Trial Description
Title
Oncological Social Care Project of the BKK
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.
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.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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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-
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
Interventions/Observational Groups
- Intervention Group with 150 patients: Support through 12 structured interviews and specific measures (if necessary) within 1 year
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Controll group with 200 patients. No Support from the Social Care Nurse
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
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.
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.
Countries of Recruitment
- Germany
Locations of Recruitment
- Medical Center
- Medical Center
- University Medical Center
Recruitment
- Actual
- 2018/02/05
- 350
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
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
Exclusion Criteria
advanced dementia, acute addiction
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
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 030 450 529195
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- oscar at charite.de
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- Institut für Medizinische Soziologie und Rehabilitationswissenschaft
- Mr. Johann Frick
- Charitéplatz 1
- 10117 Berlin
- Germany
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- oscar at charite.de
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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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