In the use of the treatment manual before the trial starts.
In the use of the treatment manual before the trial starts. Training includes a full treatment cycle with at least one patient per treatment group using video feedback and professional supervision of each treatment session. During the whole study therapists are under ongoing supervision by highly experienced psycho-oncologists. Both types of interventions are manualized and each therapist will treat a comparable number of patients in each group. Treatment fidelity is assessed and rated before approval of therapists to start in this trial. All sessions will be videotaped and an amount of 33 will be selected randomly and rated by an independent rater.Psychological interventionsRandomization follows after completing baseline assessment. Patients are equally allocated to one of the three treatment arms using sealed envelopes. Assignment follows a stratified permuted block randomization procedureIn the intervention groups three individual sessions of 50?5 minutes are being held with a clinical psychologist over the course of three to four weeks (see Figure 2).Start of AET-intake Standardized patient education 1.Session 2.Session 3.Session 1.Booster call 2.Booster call 3.Booster call1 Breast surgery Tumor board conference29 Timeline in weeks (approx.)Figure 2 Intervention schedule.von Blanckenburg et al. BMC Cancer 2013, 13:426 http://www.biomedcentral.com/1471-2407/13/Page 5 ofOne, three and six months after the intervention booster telephone calls will be made in both intervention groups.Intervention: side-effect prevention trainingTable 1 Intervention components and goals of the side-effect prevention trainingIntervention components Session 1 – Psychoeducation about AET – Guided imagination and visualization of positive treatment aspects – Psychoeducation about nocebo and non-specific side effects Homework – Practice relaxation and imagination (anchored by CD) – Further creative work with imagination, e.g., painting Session 2 – Develop individual problem-solving – Optimize coping expectations scheme for the three most important side effects – Create an action plan for behavioral and cognitive Mirogabalin site strategies Homework – Complete and modify the personal problem-solving scheme – Create an individual “tool box” – Practice relaxation and imagination (anchored by CD) Session 3 – Psychoeducation about doctorpatient communication – Develop distraction strategies of for the time of AET intake – Summing up and outline treatment goals Homework – Practice relaxation and imagination (anchored by CD) – Complete and modify the personal problem-solving scheme and the tool box PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/26437915 Telefone booster calls – Compare expected and occurred side effects – Check practicability of the coping strategies and the “tool box” and modify if necessaryNotes: AET = Adjuvant endocrine therapyGoals – Knowledge about PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/26162776 AET and nocebo effect – Strengthen control and benefit expectations – Integration of positive aspects of AET into daily routinesThe goal of SEPT is the prevention of non-specific and nocebo side effects from endocrine therapy by optimizing treatment- and illness-related expectations. Contents of the training are psychoeducation [41] to provide a realistic view of the treatment, imagination-training to integrate positive aspects of medication into daily life and side-effect management [42] to enhance expectations about individual coping abilities. All intervention components and goals are listed in Table 1. SEPT is a manual-based program. Individual topics are adapted spe.