Trial document





This trial has been registered retrospectively.
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  DRKS00015788

Trial Description

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Title

NCT Mobile - Smartphone-Based Video Consultations in Medical Oncology

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Trial Acronym

NCT-MOBILE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The NCT-MOBILE trial will compare patient-physician consultations via a dedicated video consultation smartphone application with in-person office consultations in oncological patients.

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Brief Summary in Scientific Language

The NCT-MOBILE trial is a single center randomized open label clinical trial to evaluate feasibility of patient-physician video consultations in oncological outpatients with solid tumors. After initiation of a cancer specific therapy 66 patients will be randomly assigned, in a 1:1 ratio, to receive video consultations via a dedicated smartphone application or in-person consultation at the outpatient clinic. Primary endpoint is the rate of successful patient-physician consultations at the first planned visit 2-14 days after initiation of a cancer specific therapy.

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Organizational Data

  •   DRKS00015788
  •   2018/10/26
  •   [---]*
  •   yes
  •   Approved
  •   S-090/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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

  •   solid malignant tumors (ICD-10 C00-C80)
  •   C00-C75 -  Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic and related tissue
  •   C76-C80 -  Malignant neoplasms of ill-defined, secondary and unspecified sites
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Interventions/Observational Groups

  •   After initiation of a cancer specific therapy (oral or intravenous), patients receive a follow-up video call consultation within 2-14 days via a dedicated smartphone application (Focus Health, Minxli Ltd.). Up to 6 months after randomization patients can receive additional physician consultations within the NCT MOBILE trial. These consultation can be either in-person or via video call depending on the preferences of the patient and the treating physician.
  •   After initiation of a cancer specific therapy (oral or intravenous), patients receive a follow-up in-person consultation within 2-14 days at the outpatient clinic. Up to 6 months after randomization patients can receive additional physician consultations within the NCT MOBILE trial. These consultations have to be in-person at the outpatient clinic.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Feasibility (Rate of successful patient-physician consultations at first planned visit 2-14 days after initiation of a systemic cancer therapy)

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Secondary Outcome

Time efficiency (for patient and physician)
Patient satisfaction with physician-patient interaction;
Patient overall satisfaction with video consultations

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/11/29
  •   66
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients:
Outpatients with solid tumors (main diagnosis: C00-C80 ICD-10-GM);
planned follow-up visit within 2-14 days;
patient has a smartphone;
written informed consent for study participation;
patient agrees with terms and conditions of the "Focus Health" application (Minxli Ltd.);
ECOG 0-2.

Physicians:
Medical oncologist of the National Center for Tumor Diseases (NCT) Heidelberg, Germany;
consent to participate;
physician has a smartphone.

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Exclusion Criteria

Age <18 years;
not German speaking;
severe visual or auditory impairment.

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Addresses

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    • National Center for Tumor Diseases (NCT) Heidelberg
    • Im Neuenheimer Feld 460
    • 69120  Heidelberg
    • Germany
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    • National Center for Tumor Diseases (NCT) Heidelberg
    • Mr.  Thomas  Walle 
    • Im Neuenheimer Feld 460
    • 69120  Heidelberg
    • Germany
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    • National Center for Tumor Diseases (NCT) Heidelberg
    • Mr.  Thomas  Walle 
    • Im Neuenheimer Feld 460
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • National Center for Tumor Diseases (NCT) Heidelberg Department of Medical Oncology
    • Im Neuenheimer Feld 460
    • 69120  Heidelberg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Minxli Services UG
    • Ms.  Jennifer  Kelly 
    • Prannerstrasse 10
    • 80333  München
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Ethics Committee
  •   Study Protocol
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* This entry means the parameter is not applicable or has not been set.