Trial document





This trial has been registered retrospectively.
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  DRKS00016703

Trial Description

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Title

Patient information, communication and competence empowerment in oncology

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Trial Acronym

PIKKO

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URL of the Trial

https://www.pikko.de/

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Brief Summary in Lay Language

The chances of recovery for cancer patients should be increased by an additional supply of advice and information. In addition to the conventional medical treatment, the patients get support by a patient navigator, can take advantage of specialized oncological counseling (e.g. social counseling, psycho-oncological counseling, sports and nutritional counseling) and gain access to a new digital oncological knowledge database providing quality-assured information about cancer. The patients receive additional orientation in health care to enable them to make self-determined decisions about their treatment. Furthermore, they can be provided with have psychological support.
During the project a variety of data will be collected, i.a. questionnaire data, interviews and direct health care costs. The effects and benefits of the additional offers are shown by comparing the control and intervention groups.

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Brief Summary in Scientific Language

During the project PIKKO the conventional cancer care is expanded by an additional advice and information path. The three central elements are a patient navigator, a specialized oncological counseling and an oncological knowledge database.
The specially trained patient navigators support the patients during the therapy and provide them with relevant information about their disease. The specialized oncological counseling support patients in psychosocial matters. The oncological knowledge database is a newly developed information tool to improve patient education concerning their disease. These three modules are supplemented by an onco-expert-phone, which enables the attending physician to obtain relevant information and advice from selected oncology specialists if required.
The evaluation works with patient surveys, secondary data analysis provided by statutory health insurances companies, interviews with service providers as well as usage data of the oncological knowledge database.
After six months, patients of the intervention group are expected to report a higher health-related quality of life (SF12), less mental impairment (PHQ-9, GAD-4), better self-management (SWE), and higher health literacy (HLS-EU-Q47) than patients of the control group. Furthermore, the intervention should result in lower medical costs (days of inability to work, sick-pay, expenses of health benefits).

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Organizational Data

  •   DRKS00016703
  •   2019/02/21
  •   [---]*
  •   no
  •   Approved
  •   114/17, Ethik-Kommission bei der Ärztekammer des Saarlandes
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Secondary IDs

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Health Condition or Problem studied

  •   C00-C97 -  Malignant neoplasms
  •   D45 -  Polycythaemia vera
  •   D46 -  Myelodysplastic syndromes
  •   D47 -  Other neoplasms of uncertain or unknown behaviour of lymphoid, haematopoietic and related tissue
  •   D48 -  Neoplasm of uncertain or unknown behaviour of other and unspecified sites
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Interventions/Observational Groups

  •   Treatment as usual additional advice and information path with patient navigators, oncological knowledge database, specialized oncological counseling
  •   Treatment as usual, opportunity sample
  •   Treatment as usual, random sample
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Supportive care
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Health-related quality of life (SF-12), measured by pre-intervention questionnaires plus 3 and 6 months after baseline

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Secondary Outcome

Self-efficacy (SWE), depression (PHQ9), anxiety (GAD7), health literacy (HLS-EU-47), treatment satisfaction (Qualiskope-A): measured with pre-intervention questionnaires plus 3 and 6 months after baseline.
Furthermore, direct medical costs (days of inability to work, sick-pay, ambulant and hospital treatment, medication costs, use of psychotherapeutic treatments) are identified from secondary data analysis from health insurances.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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  • Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2017/11/06
  •   1014
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

Diagnosis of diagnosis groups C00-C97 or D45-D48; initial diagnosis, relapse and transition to palliative care; treatment by doctors from the Saarland; insured with one of the health insurances participating in this study

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Exclusion Criteria

statutory guardianship; insufficient knowledge of the German language; very strong visual and hearing impairment; dementia; mental limitations

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Addresses

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    • IKK Südwest
    • Berliner Promenade 1
    • 66111  Saarbrücken
    • Germany
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    •   0681-936962046
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    • Universitätsklinikum Jena, Institut für Psychosoziale Medizin und Psychotherapie
    • Mr.  Prof. Dr. phil. habil.  Bernhard  Strauß 
    • Stoystaße 3
    • 07740  Jena
    • Germany
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    • Deutsche Krebsgesellschaft e.V.
    • Mr.  Dr. med.  Christian  Keinki 
    • Kuno-Fischer-Straße 8
    • 14057  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsausschuss beim Gemeinsamen Bundesausschuss
    • Postfach 12 06 06
    • 10596  Berlin
    • 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.