Trial document





This trial has been registered retrospectively.
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  DRKS00009501

Trial Description

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Title

Reducing the subjective experience of side effects during chemotherapy through education about the Nocebo-effect in therapy-naive patients with gastrointestinal tumors - RENNO study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

This study investigates the role of information about the nocebo-effect on experiencing side effects. Secondly, this trial examines the effect of information about side effect-related experience, toxicity, intake of supportive medication, coping of side effects and patient compliance during chemotherapy. Patients are randomized to an experimental group (information about the nocebo-effect) or the control group (interview about quality of life) in this univariate design.

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Organizational Data

  •   DRKS00009501
  •   2018/03/27
  •   [---]*
  •   yes
  •   Approved
  •   [---]*, Ethikkommission der Fakultät für Psychologie und Bewegungswissenschaft der Universität Hamburg
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Secondary IDs

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Health Condition or Problem studied

  •   gastrointestinal tumors
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Interventions/Observational Groups

  •   Experimental arm: Patients receive information about the nocebo-effect
  •   control arm: Patients receive information about quality of life (instead of information about the nocebo-effect)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary outcome: Experiencing of side effects. We use an adapted version of the GASE (General assessment of side effects scale) containing the 4 main side effects after chemotherapy (nausea, vomiting, diarrhea, fatigue) and 3 more unspecified side effects (headache, dyspnea, skin rash) on a 10-level scale. The overall impact of side effects for the last 7 days is measured. The attribution of side effects on the medical product is determined. Follow up surveys take place on day 10 (T2) and 12 weeks (T3) after start of therapy. Questionnaires will be sent by mail.

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Secondary Outcome

Toxicity: toxicity will be questioned by Common Toxicity Criteria Version 4 at baseline and prior every cycle of therapy. Coping of side effects will be interrogated by questionnaire (10-level scale) asking on managing side effects.
Patient compliance while on chemotherapy will be determined by observation of behaviour and noted in in the electronical health record. The intention to complete therapy and the estimated probability to discontinue therapy will be recorded.
Side effect-related expectations will be recorded with 8 items before and after information on nocebo or control intervention.
On a 10-level scale patients will be asked to determine the range of expectancy of the following side effects: nausea, diarrhea, fatigue, headache, dyspnea, skin rash.
Coping expectancy on side effects: on a 10-level scale patients will be asked to note how they expect to manage and control side effects. Patients are asked to state whether chemotherapy will help them and how far they believe to influence the course of disease themselves.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2016/01/01
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

1. newly diagnosed tumor of gastrointestinal tract
2. therapy-naive patient
3. planned chemotherapy with/without monoclonal antibody (except EGFR-inhibitors) neoadjuvant, adjuvant or palliative
4. ECOG < 2
5. 18 years or older
6. adequate knowledge of German language
7. signed informed consent

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Exclusion Criteria

1. prior chemotherapy
2. combination of EGFR inhibitor (Cetuximab or Panitumumab) or combination with inhibitor of tyrosinkinase domain of EGF-receptor (Erlotonib)
3. prior skin disease
4. anamnestic chronic pulmonary disease
5. dyspnea and skin disease before start of therapy
6. acute mental stress or illness that may affect quality of life (physician's opinion)

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Addresses

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    • Universitätsklinikum Hamburg-Eppendorf
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   http://uke.de
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    • Institut und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf
    • Ms.  Prof. Dr.  Yvonne  Nestoriuc 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    •   +49 (0)40 7410 52975
    •   +49 (0)40 7410 54975
    •   y.nestoriuc at uke.de
    •   [---]*
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    • Hubertus Wald Tumorzentrum, Universitäres Cancer Center Hamburg,II. Medizinische Klinik und Poliklinik, Universitätsklinikum Hamburg-Eppendorf,
    • Ms.  Julia  Quidde 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    •   +49 (0)40 7410 53552
    •   +49 (0)40 7410 56744
    •   j.quidde at uke.de
    •   [---]*
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Sources of Monetary or Material Support

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    • Institut und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf
    • Ms.  Prof. Dr.   Yvonne  Nestoriuc 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    •   +49 (0)40 7410 52975
    •   +49 (0940 7410 54975
    •   y.nestoriuc at uke.de
    •   [---]*
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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.