Reducing the subjective experience of side effects during chemotherapy through education about the Nocebo-effect in therapy-naive patients with gastrointestinal tumors - RENNO study
Not Applicable
- Conditions
- gastrointestinal tumors
- Registration Number
- DRKS00009501
- Lead Sponsor
- niversitätsklinikum Hamburg-Eppendorf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 100
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
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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method