Trial document



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  DRKS00014230

Trial Description

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Title

Tablet-based computer-assisted data collection of functional aspects and quality of life by patients with head and neck tumors without and with direct feedback to the attending physician in a prospective controlled care study in the Department of Otorhinolaryngology, Head and Neck Surgery, University Clinic of Schleswig-Holstein Campus Lübeck

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Trial Acronym

TaBeL

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URL of the Trial

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Brief Summary in Lay Language

Patients with head and neck cancer often are not able to express themselves in a reasonable amount of time, so important information can be lost. If doctors already have a digital submission of significant patient issues, the resulting measures are more likely to follow and their documentation will be faster, making it easier to analyse therapies. The study aims to assess functioning, symptom burden, quality of life and survival as a function of tumor stage and therapy using interactive systems without or with feedback from patients in the routine care of patients with head and neck cancer. The question is whether there are differences between the patients with and without intervention regarding the digital feedback of the data of the patient survey to the physician 15 months after completion of the radiotherapy with regard to self-assessed health status, quality of life, pain and discomfort.

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Brief Summary in Scientific Language

Functional impairments in head and neck tumors have so far been inadequately standardised in everyday clinical practice and considered in the context of general burden of symptom, survival and therapy as well as quality of life or used for direct care. The identification of risk factors in the course of treatment is insufficiently clarified, especially in follow-up depending on tumor stage and therapy.

Patients with head and neck cancers are often unable to adequately articulate in a timely manner so that they do not necessarily communicate relevant information. If physicians already have a digital presentation of significant patient problems, the resulting measures are more likely to follow and their documentation faster, which also makes it easier to analyse individual and collective treatment pathways.

New technical and design options for spatially flexible and mobile tablet-based data collection, task-oriented and immediate multimedia processing and the use of this information for routine care have hardly been established in this context. Experience with computer-assisted quality of life measurements indicates benefits for patients and physicians.

Since even the few known systems would have to be elaborately adapted and completed, local experts are developing or integrating interactive multimedia systems with user-friendly user interfaces. These are intended on the one hand to enable the data input by patients on a tablet PC, on the other hand, the multimedia data processing and the meaningful, fast and secure to be recorded representation of this data immediately for the doctor consultation.

A prospective nonrandomised controlled monocentric care study is being conducted in patients with head and neck tumors in the waiting group design. To evaluate the effects of including digital patient and physician information in therapy, a bipartite approach is planned (Phase 1 + 2). In the first phase of the project, the implementation of the digital patient survey and doctor checklist will be carried out with standardised tools for self- and external assessment. The data is encrypted, transferred to the study database and stored. The treatment is as usual. In the second phase of the project, individual results of the patient survey are displayed to the attending physician in a multimedia format so that they are immediately available for patient care and can be used for decision-making support. The digitally documented data on performance, results of the examination, abnormalities, side effects of the therapy (according to CTCAE) and resulting measures are also processed by multimedia. Time trends are displayed and defined values ​​are stored visually, whereby standard deviations become visible.

It examines the question of whether between patients with standardised digital survey and use
Patient Reported Outcomes (PROs), general burden of symptom, functional ability, therapy and survival significant differences to patients without use of these digital data 15 months after completion of radiotherapy.

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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

  •   DRKS00014230
  •   2018/03/07
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  •   yes
  •   Approved
  •   17-373, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

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Health Condition or Problem studied

  •   C01 -  Malignant neoplasm of base of tongue
  •   C02 -  Malignant neoplasm of other and unspecified parts of tongue
  •   C03 -  Malignant neoplasm of gum
  •   C04 -  Malignant neoplasm of floor of mouth
  •   C05 -  Malignant neoplasm of palate
  •   C06 -  Malignant neoplasm of other and unspecified parts of mouth
  •   C07 -  Malignant neoplasm of parotid gland
  •   C08 -  Malignant neoplasm of other and unspecified major salivary glands
  •   C09 -  Malignant neoplasm of tonsil
  •   C10 -  Malignant neoplasm of oropharynx
  •   C12 -  Malignant neoplasm of piriform sinus
  •   C13 -  Malignant neoplasm of hypopharynx
  •   C30 -  Malignant neoplasm of nasal cavity and middle ear
  •   C31 -  Malignant neoplasm of accessory sinuses
  •   C32 -  Malignant neoplasm of larynx
  •   comorbidity
  •   quality of life
  •   burden of symptoms
  •   functional impairment
  •   adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE v4)
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Interventions/Observational Groups

  •   Patients with primary diagnosis of head and neck tumors, who participating on a tablet-based data colletction (PROs) and whose physician reported to a digital physician checklist on general burden of symptom, health, therapy, and side effects . The treatment is as usual. The information serves as a control and is not available to the attending physician.

  •   Patients with primary diagnosis of head and neck tumors, who participating on a tablet-based data colletction (PROs) and whose physician reported to a digital physician checklist on general burden of symptom, health, therapy, and side effects . The data are processed in a multimedia format and are available to the attending physician for the purpose of providing decision support for the treatment. In doing so, temporal trends and abnormal results are visually highlighted.
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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)
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

EORTC QLQ-C30 (subscale fatigue, general health and quality of life, gastrointestinal side effects);

Data collection: using a tablet-based patient survey and digital doctor checklist;

time of measurement: before the start of therapy, after completion of the primary therapy, directly after radiotherapy, 3, 6, 9 12 and 15 months after irradiation;

The study aims to assess the functional ability, symptom burden and quality of life as a function of tumor stage and therapy by means of interactive systems in the routine practical care of patients with head and neck cancer.

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Secondary Outcome

Pain, GAD-2, PHQ-9, social score, rehabilitation needs, EAT-10, survival

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/05/07
  •   320
  •   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 with diagnosis ICD-10 C01-C10, C12-13 or C30-C32; sufficient knowledge of German in spoken and written

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Exclusion Criteria

non-existent consent, emergency patients, patients younger than 18 years of study, patients with intellectual disability (ICD-10 F70-F79), dementia, Alzheimer's disease

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Addresses

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    • Universität zu Lübeck
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    • Universität zu Lübeck
    • Ms.  Elke  Peters 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    • Universität zu Lübeck
    • Ms.  Elke  Peters 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Stiftung Deutsche Krebshilfe
    • 53113  Bonn
    • Germany
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    •   +49228729900
    •   +492287299011
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    • Universität zu Lübeck
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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Status

  •   Recruiting complete, follow-up complete
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  •   2021/08/31
  •   319
  •   319
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Trial Publications, Results and other Documents

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