Trial document




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  DRKS00015773

Trial Description

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Title

Effects of an EEG neurofeedback intervention in cancer patients

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Trial Acronym

Neuro-ID

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URL of the Trial

http:///

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Neurofeedback (NF) or EEG-Feedback is a “noninvasive, drugfree form of brain training“ and it is a technique that measures a subject’s EEG signal, processes it in real time, with the goal to effectuate a behavioral modification by modulating brain activity. The most common application of the neurofeedback technology is in: epilepsies, migraine, attentional-deficit/hyperactivity disorder, autism spectrum disorder, affective disorders and psychotic disorders. Few studies have investigated the use of NF in context of psychosomatic illnesses but hardly one can be found for cancer patients or postcancer survivors despite the high number of this patient group.
Aim of this controlled, randomized clinical waitlist-investigation is the implementation and efficacy verification of a NF intervention in psycho-oncological patients with malignant oncological diagnosis (Amendment, date: 29.01.2019; vote: 11.04.2019). In addition, to compare the effectiveness of this measure with a therapy already common in cancer patients, the effects are compared with those of a mindfulness group therapy. Therefore, 80 patients will take part in (a) a NF intervention (N = 40) or (b) a mindfulness group therapy (N = 40), after a 5-week waitlist period and randomization. Based on the theoretical assumptions, we expect changes in the alpha band power caused by the NF training and reduction of negative cancer impairments. We also expect changes by the mindfulness therapy. Comparing the two interventions, we expect higher symptom improvements by the NF.

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Organizational Data

  •   DRKS00015773
  •   2018/10/23
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  •   yes
  •   Approved
  •   18-8079-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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Health Condition or Problem studied

  •   F43.2 -  Adjustment disorders
  •   C00-C97 -  Malignant neoplasms
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Interventions/Observational Groups

  •   Neurofeedback-Paradigm: N = 40

    Neurofeedback training will performed with the Mind Wave Headset (NeuroSky & Inc, 2011) and the electrode will be placed on Cz. The investigator will be present throughout neurofeedback training, but will not give verbal feedback during sessions. The feedback is displayed on the monitor as a target state during the training. Each intervention involves a total of 10 training sessions over 5 weeks, so each patient practices twice a week. Each session consists of a 35-40 minute paradigm:

    • 5 min: resting state
    • 10 min: α-bandwidth (9Hz - 13Hz) attenuation and theta/beta (> 20 Hz) reduction
    • 5 min: resting state
    • 5 min: theta/beta-bandwidth (target: theta/beta-Ratio ≤ 2,5)
    • 5 min: resting state
    • 10 min: α-bandwidth (9Hz - 13Hz) attenuation and theta/beta (> 20 Hz) reduction
  •   Mindfulness group therapy: N = 40

    Mindfulness-Based Cognitive Therapy (MBCT) was adapted as a treatment to prevent e.g. relapse in depression (Teasdale et al., 2002). Teasdale, Williams, Segal, & Kabat-Zinn (2015) proposed an 8-week program for mindfulness skills-based training. The Mindfulness-Based Stress Reduction (MBSR) by Kabat-Zinn & Kappen (2013) also offers many exercises to be carried out daily over a longer period of time. The exercises by Lohmann, Annies, & Ubben (2016) are simple, short and generally practicable while seated. We will use a mixture of the proposed interventions to achieve a training duration of 35-40 minutes per session, similar to the NF-sessions. Similar to the NF intervention, the mindfulness training will be carried out twice a week. The groups will have a size of 8-10 patients.
  •   Waitlist control group: N = 80
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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), Control group receives no treatment
  •   Supportive care
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

Alleviation of cognitive impairements of cancer patients.

Instruments:
•Functional Assessment of Cancer Therapy – Cognitive Function [FACT-Cog] (Bonomi et al., 1996)

Measurement:
t0 = inclusion in study
t1 = after 5-week waitlist period/ before intervention
t2 = after intervention

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Secondary Outcome

- Alleviation of psychological impairments of cancer patients (e.g. distress, fatique and general symptoms)

Instruments:
•Psycho-Onkologische Basisdokumentation [PO-Bado] (Herschbach et al., 2008)
•Distress Thermometer (Mehnert et al., 2006)
•Hornheider Screening Instrument [HIS] (Strittmatter et al., 2003)
•Multidimensionales Fatigue-Inventar [MFI-20] (Smets et al., 1996)
•Patient Health Questionnaire Depression Scale [PHQ-8] (Kroenke et al., 2009)
•Generalized Anxiety Disorder Scale-7 [GAD-7] (Spitzer et al., 2006)
•Ruminative Antwort Skala des Response Styles Questionnaire [RSQ] (Kuehner & Buerger, 2005)

- changes in the alpha band power.

- inceased quality of life: European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire [EORTC QLQ-C30] (Aaronson et al., 1993)

measurement:
t0 = inclusion in study
t1 = after 5-week waitlist period/ before intervention
t2 = after intervention

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/10/25
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patient with cancer diagnosis (all cancer types, all stages) will be included.

The participant with provided informed consent.

Age: 18-70 years.

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Exclusion Criteria

Patients with major depression (F 32.2 or F33.3) or acute suicidality, patients with psychotic symptoms/diseases and/or central nervous system disease.
A lack of language skills.

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Addresses

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    • Klinik für Psychosomatische Medizin und PsychotherapieKliniken und Institut der Universität Duisburg-EssenLVR-Klinikum Essen
    • Mr.  Prof. Dr. med.  Martin  Teufel 
    • Virchowstraße 174
    • 45147  Essen
    • Germany
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    • Klinik für Dermatologie, Universität Duisburg-Essen, Hauttumorzentrum
    • Mr.  Prof. Dr. med.  Schadendorf 
    • Hufelandstraße 55
    • 45145  Essen
    • Germany
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    • Innere Klinik (Tumorforschung) am Westdeutschen Tumorzentrum des Universitätsklinikums Essen
    • Mr.  Prof. Dr. med.  Schuler 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Klinik für Psychosomatische Medizin und Psychotherapie LVR-Klinikum Essen Kliniken / Institut der Universität Duisburg-Essen
    • Ms.  M. Sc.  Madeleine  Hetkamp 
    • Virchowstr. 174
    • 45147  Essen
    • Germany
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    • Innere Klinik (Tumorforschung) am Westdeutsches Tumorzentrum des Universitätsklinikum Essen
    • Ms.  PD. Dr. med.  Mitra  Tewes 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Klinik für Psychosomatische Medizin und Psychotherapie LVR-Klinikum Essen Kliniken / Institut der Universität Duisburg-Essen
    • Ms.  M. Sc.  Madeleine  Hetkamp 
    • Virchowstr. 174
    • 45147  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Psychosomatische Medizin und Psychotherapie LVR-Klinikum Essen Kliniken / Institut der Universität Duisburg-Essen
    • Virchowstraße 174
    • 45147  Essen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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