C50
Conditions
Interventions
Group 1: Breast cancer patients undergo
integrative cancer treatment including regular cancer treatment (such as operation, chemotherapy, radiotherapy, endocrine therapy,
etc.) as well as individualiz
Sponsors
Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Female patients with primary breast cancer (TNM: I-III)
Exclusion criteria
Exclusion criteria: • Men • Hospitalization due to plastic surgery, treatment of a benign tumor, carcinoma in situ, cancer recurrence or metastasis • Severe comorbid somatic disease or psychopharmacological treated psychiatric or degenerative disorder (dementia, major depression, psychosis) due to which a patient is unable to participate in the study • Insufficient knowledge of the German language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment response regarding: • Patient reported outcomes: Quality of life (FACT-G) and Fatigue (FACIT-F), • Adherence to chemotherapy and endocrine therapy, • Progression-based outcomes: Invasive Disease-Free Survival (IDFS), Distant Relapse-free Survival (DRFS), Breast Cancer Specific Survival (BCSS) and Overall Survival (OV). We will conduct analyses of combined response (best cases) as well as of response on single outcomes and time points. All analyses will be exploratory. Time Points: T0=Baseline (after diagnosis), T1= after ending of the neo-/adjuvant chemotherapy, T2=after ending of all adjuvant treatments, T3=1-year-follow-up, T4=2-year-follow-up, T5=5-year-follow-up, T6=10-year-follow-up. Predictors: • Socio-demographics: age, education • Cancer data: time of diagnosis, histology, recurrence, previous oncological disease, TNM-staging, grading, menopausal state, hormone receptor state, hereditary risk score • Comorbidity: HRQL-CI, ECOG, Karnofsky-performance status scale • Coping: Stress perception (QSC), depression (CESD-SF10), hopelessness (BH-NEG), anxiety (PROMIS-SF4), progression anxiety (FRRS), emotion regulation (ERQ), sleep disorders (PROMIS-SF4), spirituality (FACIT-SP), social support (BSSS) • Lifestyle / environmental factors: alcohol and smoking behavior, medication, exercise (IPAQ) and diet (MEDAS), body mass index, radiation exposure • Oncological therapies (pre- and postoperative) • Side effects: adverse events (MSAS / CTCAE) • Complementary therapies: CAM-beliefs (CHBQ), interest in CAM (VAS), use of CAM (I-CAM-Q) • Satisfaction with therapy (CSQ) • Study center. | — |
Countries
Germany
Contacts
Public ContactAnnette;Petra Haman;Voiss
Breast Unit, Diakoneo Diak Klinikum;Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
Outcome results
None listed