Rationale and study design of a trial to assess rTMS add-on value for the amelioration of negative symptoms of schizophrenia (RADOVAN).

BACKGROUND: Schizophrenia is a severe and often difficult to treat psychiatric illness. In many patients, negative symptoms dominate the clinical picture. Meta-analysis has suggested moderate, but significant effects of high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) on these symptoms. For treatment of depression a much shorter protocol - intermittent theta burst stimulation (iTBS) - has shown to be non-inferior to conventional high-frequency rTMS. This randomized, sham-controlled, rater-blinded clinical trial assesses the effects of conventional HF-rTMS as well as of iTBS of the left dorsolateral prefrontal cortex in comparison with sham. METHODS: The study will be conducted at two psychiatric university hospitals in Germany and at two in the Czech Republic. Assuming an effect size of 0.64 to be detected with a power of 80%, the calculated sample size is 90 patients. Primary outcome will be the difference in the Scale for the Assessment of Negative Symptoms (SANS) score between each active arm and the sham arm at end of treatment.In addition, the trial investigates effects on depressive symptoms, cognitive performance and cigarette smoking. Recording magnetic resonance imaging (MRI) and electroencephalography (EEG) data will serve to assess whether treatment success can be predicted by neural markers and is related to specific neurobiological changes. DISCUSSION: This is a clinical trial directly comparing 10 Hz-rTMS and iTBS in a sham-controlled manner in treating negative symptoms of schizophrenia. If successful, this would present an interesting treatment option for a chronic and severe condition that can be applied at most psychiatric hospitals and only takes up a few minutes per day. TRIAL REGISTRATION NUMBER: This trial has been registered at clinicaltrials.gov, Identifier: NCT04318977. DATA DISSEMINATION: Results from the trial shall be published in peer-reviewed journals and presented at meetings and conferences.

Screening of Psychological Distress 4.5 Years after Diagnosis in Breast Cancer Patients Compared to Healthy Population.

BACKGROUND: Survival rate of breast cancer patients has improved significantly in recent years. Cancer diagnosis represents a great psychological distress for patients which may not stem solely from the disease itself. Patients may experience higher distress even several years after treatment. PATIENTS AND METHODS: The study was carried out at the Department of Obstetrics and Gynecology and Department of Internal Medicine, Haematology and Oncology, Faculty Hospital Brno. Results of 85 patients at 4.5 years after diagnosis of breast cancer compared to 72 healthy controls are presented in this paper. The data were collected in the form of semi-structured interviews, from the patients medical records and by Symp-tom Check List-90. RESULTS: The overall rate of psychological distress (GSI) 4.5 years after breast cancer dia-gnosis does not differ significantly (p = 0.703) from the healthy population. Also, we did not find any statistically significant relationship between the observed factors and the level of psychological distress in breast cancer patients. CONCLUSION: Screening investigation showed no difference in the psychological distress in breast cancer patients 4.5 years following diagnosis, compared with the healthy population.

Change in Quality of Life Measured over Time in Czech Women with Breast Cancer.

BACKGROUND: This study examined the impact of breast cancer on quality of life (QOL) of Czech women by comparing the QOL of breast cancer patients with that of age-matched healthy controls. METHODS: The sample consisted of 74 breast cancer patients who filled in self-assessment questionnaires retrospectively before treatment and at the time of the study. In addition, 73 healthy controls completed the same battery of questionnaires. QOL was assessed using the Rand 36-Item Health Survey, the Life Satisfaction Questionnaire, and the Czech research version of Functional Assessment of Breast Cancer Therapy. The Wilcoxon paired test and Mann-Whitney U test were used for data analysis. RESULTS: A statistically significant decline in QOL in breast cancer patients was found for the following components: Physical Functioning (p = 0.021), Role Functioning-Physical (p < 0.001), Bodily Pain (p = 0.001), General Health (p = 0.031), Role Functioning-Emotional (p = 0.023), and Physical Well-being (p = 0.001). The only significant increase over time was observed in Social/Family Well-being (p = 0.024). For most of the components, patients showed a statistically significant lower QOL than that of healthy controls. A recent diagnosis, advanced disease stage, more comorbidities, a higher BMI, and other sociodemographic characteristics were associated with a higher incidence of a lower QOL over time. CONCLUSION: Perceived QOL decreased over time in breast cancer patients mainly in components such as physical and emotional functioning, bodily pain, and general health, with several risk factors strongly influencing this change. The QOL of patients was lower than that of the non-cancer population, indicating that subsequent care should be improved to minimize the adverse effects that breast cancer has on QOL.

Predicting Vitality Change in Older Breast Cancer Survivors after Primary Treatment--an Approach Based on Using Time-related Difference of Pro-inflammatory Marker C-reactive Protein.

BACKROUND: We aimed to determine prognosis of vitality change and functional status of breast cancer survivors after primary oncological treatment using time-related differences of elevated levels of highly sensitive proinflammatory C-reactive protein (CRP). PATIENTS AND METHODS: The test group consisted of 46 elderly breast cancer survivors (median age was 65 years) who completed Vitality Scale of Short Form 36 (SF-36) after completing treatment and another retrospectively at diagnosis. Data on tumor-related factors, treatment, and outcomes were obtained retrospectively from medical records, and linear regression analysis was performed. CRP was followed at diagnosis and one year after primary treatment. Within the scope of this study, clinically important difference in the Vitality Scale was set at five points of change. RESULTS: Results showed a statistically significant relationship between CRP change and vitality component of SF-36 change (rs = - 0.350, p = 0.023) in which a decrease in CRP inversely correlated with the quality of life component. The overall change was 1.078 of the vitality scale score (approximately 1 point) for each 1 unit decrease of CRP (1 mg/ L). Association of CRP levels (before and after treatment, its difference between these time points) with age, number of comorbidities and stage of the disease was analyzed and no statistically significant relationship was found in our study. CONCLUSION: Preliminary results suggested time-related differences in elevated CRP levels as a potentially suitable predictor for change in vitality status for long term, chronic condition for older breast cancer survivors. We suggest the interpretation schema including an understanding that CRP change of 5 mg/ L and more should be considered a potential risk factor for subsequent negative clinical outcomes.

[Psychoneuroimmunology in context of comprehensive breast cancer treatment]. / Aplikace poznatku psychoneuroimunologie v kontextu komplexní onkologické lécby karcinomu prsu.

BACKGROUND: Numerous studies have proven a relationship between stress and cancer progression or recurrence, and on the other hand, positive effects of psychological and social support and interventions on cancer patients quality of life. PURPOSE: This review article aims to provide an overview of recent studies that dealt with effects of psychosocial interventions on health and psychological state of breast cancer patients, from cellular and immune response over coping skills to overall survival. CONCLUSION: Both short- and long-term studies have proven positive effects of psychosocial interventions on levels of stress hormones, cellular (immune) response and general patients quality of life. On the other hand, findings on overall survival are contradictory and cannot provide unambiguous conclusions.