gastrointestinal tumors
Conditions
Interventions
Group 1: Experimental arm: Patients receive information about the nocebo-effect
Group 2: control arm: Patients receive information about quality of life (instead of information about the nocebo-effect
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactJulia Quidde
Hubertus Wald Tumorzentrum, Universitäres Cancer Center Hamburg,II. Medizinische Klinik und Poliklinik, Universitätsklinikum Hamburg-Eppendorf,
Outcome results
None listed