Trial document

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DRKS-ID: 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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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

DRKS-ID: DRKS00013640
Date of Registration in DRKS: 2017/12/29
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: EA2/192/17, Ethik-Kommission der Charité -Universitätsmedizin Berlin-

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Secondary IDs

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Health Condition or Problem studied

Free text: 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

Arm 1: Intervention Group with 150 patients: Support through 12 structured interviews and specific measures (if necessary) within 1 year
Arm 2: Controll group with 200 patients. No Support from the Social Care Nurse

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Non-randomized controlled trial
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Control group receives no treatment
Purpose: Other
Assignment: Parallel
Phase: N/A
Off-label Drug use: 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

DE: Germany

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Locations of Recruitment

Medical Center Klinikum Leverkusen, Leverkusen
Medical Center Helios St. Johannes KlinikAbteilung: Onkologie und Hämatologie, Duisburg
University Medical Center Med. Klinik m.S. Hämatologie, Onkologie und TumorimmunologieCharité - Universitätsmedizin Berlin, Berlin

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2018/02/05
Target Sample Size: 350
Monocenter/Multicenter trial: Multicenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 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

Primary Sponsor
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- pronova BKK (Konsortialführung)
- 51373 Leverkusen
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Collaborator, Other Address
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- Sächsische Krebsgesellschaft e.V.
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- Telephone: [---]*
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- E-mail: [---]*
- URL: [---]*
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Collaborator, Other Address
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- BKK Dachverband e.V.
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- Telephone: [---]*
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Contact for Scientific Queries
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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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- Telephone: 030 450 529195
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- E-mail: oscar at charite.de
- URL: [---]*
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Contact for Public Queries
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- Institut für Medizinische Soziologie und Rehabilitationswissenschaft
- Mr. Johann Frick
- Charitéplatz 1
- 10117 Berlin
- Germany
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- Telephone: 030 450 529195
- Fax: [---]*
- E-mail: oscar at charite.de
- URL: [---]*
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Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
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- Innovationsfonds beim Gemeinsamen Bundesausschuss
- Wegelystr. 8
- 10623 Berlin
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting complete, follow-up continuing
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

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