Elps breast cancer patients in the management of menopausal side effectsElps breast cancer patients in

Elps breast cancer patients in the management of menopausal side effects
Elps breast cancer patients in the management of menopausal side Z-DEVD-FMKMedChemExpress Caspase-3 Inhibitor effects and can lead to decreased levels of reported symptoms [34,35]. So far, no study has focused on optimizing expectations to prevent side effects. We therefore developed a psychological sideeffect prevention training (SEPT) to prevent side effects by optimizing patients’ expectations, which may be an effective pathway to enhance overall quality of life. This article describes the study design and the research methods to answer the following research questions: 1. Is a three-session psychological intervention effective in reducing side effects and improving quality of life during long-term intake of endocrine therapy? 2. Do treatment and side-effect expectations mediate the beneficial effects? 3. PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/28154141 Are there certain patient characteristics that predict which patients benefit the most from the training?Methods/DesignStudy designThe study is designed as dual-center, randomized controlled trial with three arms and follow-up assessment (see Figure 1). The study procedure is implemented at the Department of Gynecology, Gynecological Endocrinology and Oncology, Philipps University Marburg, Germany, and at the University Medical Center Hamburg-Eppendorf, Germany. Participants are women with hormone-receptor-positive breast cancer, scheduled to start adjuvant endocrine treatment. After signing informed consent to participate in the study and receiving medical information about endocrine treatment from the hospital staff, all patients are provided additional standardized information and patient education about the scheduled treatment by a trained research assistant/ clinical psychologist to homogenize knowledge about endocrine treatment. The structured treatment information is given verbally and through a leaflet, illustrating the physical mode of action, the desired effects, and the potential side effects of endocrine therapy. After completing baseline assessment (including symptom status and pre-treatment side-effectvon Blanckenburg et al. BMC Cancer 2013, 13:426 http://www.biomedcentral.com/1471-2407/13/Page 3 ofBreast surgeryPatient acquisition and assessment for eligibility, n =Inclusion criteria: 1. Patients, diagnosed with hormone-receptorpositive primary breast cancer 2. Scheduled to receive AET 3. Female, over 18 years old, able to speak and write German fluently, no severe depression or anxiety disorder, no schizophrenia or addictionEnrollment and Informed consent n =Tumor board review and patient education as usualAdditional standardized medical information about AET Baseline assessment (t0)Random allocation (stratified with depression scores (high vs. low) and type of medication (AI vs. Tam)AET-intake Group 1: Standard medical care (SMC) n = 55 Group 2: Standard medical care Side-effect prevention training (SEPT) n = 55 Group 3: Standard medical care Attention Control group (ACG) n =Post-treatment assessment (t1)Follow-up assesment (t2 t3) (3 and 6 months after start of AET intake)Figure 1 Study design.expectations) patients are randomly assigned to one of three groups. Group 1 receives standard medical care (SMC) only. Group 2 receives SMC and the side-effect prevention PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/28404814 training (SEPT). Group 3 receives SMC and supportive therapy as an attention control group (ACG). Outcomes are assessed homogeneously in all three groups, three and six months after the start of medication intake.ParticipantsPatients with hormone-receptor-positive primary breast cancer scheduled.