Trial document




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  DRKS00021042

Trial Description

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Title

Efficient healthcare for children with cancer using telemedicine in Schleswig-Holstein

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Trial Acronym

KULT-SH

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URL of the Trial

https://www.uksh.de/paediatrie-kiel/kultsh.html

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Brief Summary in Lay Language

Children with cancer receiving chemotherapy have secondary bone marrow failure and severe infections can occur. In order to recognize such complications in time, frequent, sometimes even daily, doctor-patient contacts in a pediatric oncology center are necessary. About one third of all appointments serve to capture vital sings and to obtain an overall clinical impression. At the other appointments, chemotherapy or transfusions as well as procedures such as bone marrow punctures are necessary.
In the KULT-SH project, a part of the on-site visits will be replaced by telemedicine. Technical sensors enable the measurement of vital parameters at home. Via the project's own KULT-SH app and a tablet PC, audio-video conferences are held with doctors of the pediatric oncology of the University Medical Center Schleswig-Holstein in Kiel. All children and adolescents with cancer from the age of 1 year who are still in intensive therapy for at least 6 months with an anticipated number of at least 2x weekly doctor-patient contacts can participate. Sufficient language skills are required and internet access must be available at home.
The aim of the study is to show an equivalence of telemedical support compared to on-site visits regarding safety aspects. Furthermore, the acceptance of telemedicine by patients and families as well as their quality of life and a possible reduction in treatment costs are evaluated.

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Brief Summary in Scientific Language

Children with cancer have an increased risk of life-threatening infections due to chemotherapy-induced immunodeficiency. In order to recognize these complications in time, high-frequency clinical visits in pediatric oncology departments are necessary. About one third of all appointments serve to capture vital parameters and identify subtle clinical signs of a beginning infection, without the need for further diagnostic or therapeutic interventions.
In the KULT-SH project, these appointments will be replaced by telemedicine. Therefore, audio-video conferences and the project’s own KULT-SH app will be used. Technical devices at home record vital parameters.
KULT-SH is a monocentric randomized crossover study at the Department of Pediatric Oncology in Kiel. First patients will be included from January 2021.
The aim of the study is to show an equivalence of telemedical support in respect to severe complications compared to on-site visits. Further outcomes are the evaluation of patient satisfaction and quality of life as well as a possible reduction of treatment costs. Therefore, quantitative, qualitative and health economic analyses are carried out.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00021042
  •   2020/04/03
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  •   yes
  •   Approved
  •   D 431/20, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C00-C97 -  Malignant neoplasms
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Interventions/Observational Groups

  •   Immediate starter: during the first 3 months, all on-site visits without the need of diagnotic or therapeutic interventions (laboratories, punctions, chemotherapy, transfusions e.g.) are replaced by telemedical visits. All other appointments remain unchanged. This period is followed by on-site visits without telemedical support also for 3 months. If desired, an on-demand telemedical period is possible. This corresponds to the process of Phase 1.
  •   Waiting Group: during the first 3 months, we carry out on-site visits without telemedical support. This period is followed by a 3-month phase during which on-site visits without the need of diagnostic or therapeutic interventions (laboratories, punctions, chemotherapy, transfusions e.g.) are replaced by telemedical visits. All the other appointments remain unchanged. If desired, an on-demand telemedical period is possible. This corresponds to the process of Phase 2 (3.-6. months).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Health care system
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Statistical evidence of equivalence of telemedical support regard to severe complications compared to on-site visits. Therefore, the cumulative score of severe complications (NCI-CTCAE) is measured after 3 and 6 months.

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Secondary Outcome

Proof that the “time-to-antibiotic” is not prolonged by the telemedical intervention compared to on-site visits

AND

Proof that patients and their families experience improvements in their health care and health status using telemedicine. "PREMS" and "PROMS" are recorded.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2021/07/27
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   1   Years
  •   25   Years
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Additional Inclusion Criteria

Newly diagnosed malignant disease or malignant disease under Treatment OR condition after allogeneic hematopoietic stem cell Transplantation under drug-immunosuppressive therapy.
AND age ≥ 1 year to 25 years.
AND therapy Duration from inclusion ≥ 6 months.
AND anticipated high-frequency contact phases ( ≥ 2 doctor-patient contacts per week during therapy).
AND internet access at home.

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Exclusion Criteria

Inclusion criteria not available AND/OR poor language skills which do not allow for a video-/audio conference

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Addresses

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    • Dekanat der Medizinischen Fakultät, Christian-Albrechts-Universität zu Kiel
    • Christian-Albrechts-Platz 4
    • 24118  Kiel
    • Germany
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    • Institut für Sozialmedizin und Epidemiologie, Universität zu Lübeck,
    • Mr.  Dr. Dr.  Fabian-Simon  Frielitz 
    • Ratzeburger Allee 160 (Haus 50)
    • 23538  Lübeck
    • Germany
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    • Institut für Medizinische Informatik und Statistik der Christian-Albrechts-Universität Kiel,
    • Mr.  Prof. Dr.  Björn  Bergh 
    • Brunswiker Str. 10
    • 24105  Kiel
    • Germany
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    • Techniker Krankenkasse, Landesvertretung Schleswig-Holstein
    • Ms.  Johanna  Kampmann 
    • Hopfenstr. 2c, I. OG
    • 24114  Kiel
    • Germany
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    • DAK-Gesundheit, Landesvertretung Schleswig-Holstein
    • Mr.  Tom  Pukowski 
    • Hopfenstr. 60
    • 24103  Kiel
    • Germany
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    • Christian-Albrechts-Universität zu Kiel, Universitätsklinikum Schleswig-Holstein, Klinik für Kinder- und Jugendmedizin I, Pädiatrische Hämatologie und Onkologie,
    • Mr.  PD Dr.  Denis Martin  Schewe 
    • Arnold-Heller-Straße 3, Haus C
    • 24105  Kiel
    • Germany
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    • Christian-Albrechts-Universität zu Kiel, Universitätsklinikum Schleswig-Holstein, Klinik für Kinder- und Jugendmedizin I, Pädiatrische Hämatologie und Onkologie,
    • Mr.  PD Dr.  Denis Martin  Schewe 
    • Arnold-Heller-Straße 3, Haus C
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsausschuss beim Gemeinsamen Bundesausschuss
    • Gutenbergstraße 13, Postfach 12 06 06
    • 10596  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   Ethikvotum
  •   Studienprotokoll
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* This entry means the parameter is not applicable or has not been set.