Development and preliminary psychometric investigation of the German Satisfaction with Comprehensive Cancer Care (SCCC) Questionnaire.

PURPOSE: The assessment of patient satisfaction during treatment is essential to provide patient-centered high-quality cancer care. Nevertheless, no German instrument assesses patient satisfaction with comprehensive cancer care, which not only includes oncological treatment, but also interpersonal quality of care as well as psychosocial support services. Based on the French REPERES-60, we developed the German Patient Satisfaction with Comprehensive Cancer Care (SCCC) questionnaire. METHODS: The REPERES-60 was translated and the items were adapted to make it applicable to the German healthcare system and across different tumor entities. Scales of the resulting instrument were extracted via principal axis factoring (PAF). Subsequently, we investigated the reliability (Cronbach's Alpha, CA), discriminatory power (corrected item-scale correlations) and convergent validity (pre-specified correlations of the SCCC with different outcomes). RESULTS: The SCCC consisted of 32 items which were subsequently tested among a sample of 333 patients across different tumor entities (response rate: 47%). Average age was 59 years (standard deviation: 14), 63% were male. PAF revealed four multi-item scales named Competence, Information, Access and Support accounting for 71% of the variance. Two single-items scales assess global satisfaction with medical and psychosocial care, respectively. CA across the multi-item scales ranged from .84 to .96. Discriminatory power was sufficiently high, with all r ≥ .5. Convergent validity was largely verified by negative associations of the four multi-item scales with depressive/anxious symptomatology (r ≥ - .18, p < .01) and fatigue/overall symptom burden (r ≥ - .14, p < .01). CONCLUSION: We developed a tool to assess patient satisfaction with comprehensive cancer care in Germany. The SCCC showed satisfactory psychometric properties. Further studies are needed to verify these preliminary findings.

Acute and Long-term Memantine Add-on Treatment to Risperidone Improves Cognitive Dysfunction in Patients with Acute and Chronic Schizophrenia.

INTRODUCTION: Patients with schizophrenia are mainly characterized by negative symptoms and cognitive dysfunction. In this proof-of-concept study we tested effects on cognition and negative symptoms of a 6- or 24-week memantine add-on treatment to risperidone in patients with acute or chronic schizophrenia. MATERIALS AND METHODS: Patients with an acute episode of schizophrenia (n=11) and predominating positive symptoms were randomized to a 6-week add-on treatment with memantine (10 mg twice a day) versus placebo and patients with chronic schizophrenia (n=13) and negative symptoms were randomized to a 24-week add-on treatment with memantine (10 mg twice a day) versus placebo. All patients received antipsychotic medication with risperidone (2-8 mg/day). Psychopathological changes were assessed with the Positive and Negative Syndrome Scale (PANSS) at baseline and after 2, 4, 6, 12, and 24 weeks. Cognitive function was measured at baseline, after 6 weeks, and 24 weeks. RESULTS: Patients with acute schizophrenia who received add-on treatment with memantine showed a significantly higher performance in attention intensity (p=0.043), problem-solving (p=0.043), verbal learning (p=0.050), and flexibility (p=0.049). Patients with chronic schizophrenia showed a significantly higher immediate memory in the memantine group compared to the placebo group (p=0.033) and a significantly greater reduction of the PANSS sum score if compared to the placebo group. DISCUSSIONS: Our study gives further evidence that memantine add-on treatment to risperidone may have neuroprotective effects and improve cognitive function in patients with schizophrenia. ClinicalTrials.gov Number: NCT00148590 and NCT00148616.

Soluble Intracellular Adhesion Molecule-1 in Patients with Unipolar or Bipolar Affective Disorders: Results from a Pilot Trial.

BACKGROUND: Immunological and vascular markers may play a role in the pathophysiology of mood disorders and mood changes. AIM: To test whether the cell adhesion molecule soluble intracellular adhesion molecule-1 (sICAM-1) may serve as a biomarker for patients with unipolar or bipolar affective disorders when compared to a healthy control group, and whether sICAM-1 blood levels change during different mood states. METHODS: sICAM-1 serum concentrations were compared between 20 healthy controls and 48 patients with affective disorders (unipolar, bipolar II and bipolar I disorder) during different mood states (euthymic mood state, depression or mania). RESULTS: When compared to healthy controls, patients with affective disorders had significantly higher sICAM-1 levels during the euthymic state (p = 0.015). Differences became more pronounced during depression (p = 0.013). When unipolar and bipolar patients were analyzed separately, unipolar patients significantly differed from controls during the euthymic and depressive mood state, while bipolar II patients showed a trend towards higher sICAM-1 levels during depression. Patients with bipolar I disorders had significantly higher sICAM-1 levels during manic states when compared to controls (p = 0.007). CONCLUSIONS: sICAM-1 elevation in unipolar and bipolar patients, independent of mood changes, might support the hypothesis of chronic immune activation and endothelial dysfunction in patients with affective disorders.

Sadness and mild cognitive impairment as predictors for interferon-alpha-induced depression in patients with hepatitis C.

BACKGROUND: Antiviral therapy with interferon-alpha (IFN-α) for hepatitis C virus (HCV) infection is associated with increased risk for depression. AIMS: To identify clinical predictors for IFN-α-induced depression during antiviral therapy for HCV infection. METHOD: Depression (defined with the Montgomery-Åsberg Depression Rating Scale (MADRS)) was evaluated before and during antiviral treatment in 91 people with chronic HCV infection without a history of psychiatric disorders. Cognitive function was evaluated using the Trail Making Test A/B (TMT A/B). (Trial registration at ClinicalTrials.gov: NCT00136318.) RESULTS: Depression during antiviral therapy was significantly associated with a baseline MADRS score of 3 or higher (P = 0.006). In total, 89% (n = 16) of patients who had a baseline score >0 for the single item sadness developed depression. Poor baseline performance in the TMT A (P = 0.027) and TMT B (P = 0.033) was predictive for severe depression. CONCLUSIONS: Pre-treatment screening for subthreshold depressive and cognitive symptoms will help to identify those at risk for IFN-α-associated depression among patients with chronic hepatitis C.

[Psychological Symptom Burden in Children and Adolescents After Leukemia or Lymphoma Diseases]. / Psychische Belastungen von Kindern und Jugendlichen nach einer Leukämie oder Lymphomerkrankung.

Psychological Symptom Burden in Children and Adolescents After Leukemia or Lymphoma Diseases. A cancer diagnosis represents a major challenge for children and young people at an early stage in life. Objective of the present study is the investigation of mental health and psychosocial burden in children and young adolescents two or more years after the treatment of leukemia (ALL, AML) or lymphoma disease (NHL) compared to peers not suffering from cancer as well as available standard values. 42 former patients and 23 healthy peers were included in the comparative analysis. In addition to socio-demographic and medical information the following validated questionnaires were used: the General Depression Scale (ADS), the Strength and Difficulties Questionnaire (SDQ) for the detection of behavioral difficulties and strengths, the KINDL-R questionnaire for assessing quality of life in children and adolescents, the Herth Hope Index (HHI), the Social Questionnaire (SFS 4-6) for assessing the educational integration and the General Self-Efficacy Scale (GSE) to measure self-efficacy. Children and young adolescent survivors of leukemia or lymphoma report significantly less depressive symptoms and significantly higher quality of life compared to a healthy age-matched comparison sample and representative standard values. Beyond, former patients do not differ significantly in psychological and psychosocial aspects compared to a healthy age-matched comparison sample and available standard values.

Antidepressant pretreatment for the prevention of interferon alfa-associated depression: a systematic review and meta-analysis.

BACKGROUND: Depression is a major complication during treatment with interferon alfa (IFN-α). AIM: The aim of this study was to clarify whether preemptive antidepressant treatment can reduce the incidence and severity of IFN-associated depression. METHOD: Based on a systematic review of the literature up to July 2012, a meta-analysis of the data from 8 trials investigating patients with malignant melanoma or hepatitis C was performed. The influence of antidepressants on the incidence of major depression and depression severity was defined as the primary outcome and the influence of somatic disorder, psychiatric comorbidity, type of antidepressants, type of IFN, and possible effects on treatment outcome as secondary outcome criteria. RESULTS: Antidepressant pretreatment reduced the overall incidence of major depression during IFN treatment in all patients (odds ratio = 0.42; 95% confidence interval, 0.26-0.68; p < 0.001, n = 589) and was associated with lower mean depression scores after 12 weeks of IFN treatment (g = -0.37; 95% confidence interval -0.59 to -0.18; p < 0.001, n = 375). For patients with hepatitis C virus infection, antidepressants reduced the incidence of major depression (odds ratio = 0.38; 95% confidence interval 0.22-0.66; p < 0.001, n = 549) and the mean depression scores after 24 weeks of IFN treatment (g = -0.50; 95% confidence interval -0.70 to -0.29; p < 0.001, n = 335). The effects of selective serotonin reuptake inhibitors on the incidence and severity of depression were not dependent on pre-existing psychiatric disorders. CONCLUSION: Antidepressant pretreatment with selective serotonin reuptake inhibitors lowers the incidence and severity of IFN-associated depression in patients with chronic hepatitis C infection or malignant melanoma.

Evaluation of an electronic psycho-oncological adaptive screening program (EPAS) with immediate patient feedback: findings from a German cluster intervention study.

PURPOSE: Distress screening has become mandatory and essential in comprehensive cancer care. We evaluated an electronic psycho-oncological adaptive screening (EPAS) which assesses objective indicators of care needs and subjectively perceived care needs and subsequently provides patient feedback with individualized recommendations about psychosocial care services. METHODS: Patients were assessed within clusters, i.e., different oncological facilities of the competence network of the University Cancer Center Hamburg (UCCH). Patients in the intervention arm underwent the screening, controls received standard care. Patients were assessed at baseline (t0), 3-month (t1), and 6-month (t2) follow-up. Outcomes included information level and use of/access to nine psychosocial services at UCCH, well-being (GAD-7, PHQ-9, SF-8), and treatment satisfaction (SCCC). Conditional linear and logistic regressions were used to identify screening effects at t1 and t2. RESULTS: Of 1320 eligible patients across 11 clusters, 660 were included (50%). The average age was 60 years; 46% were female. The intervention was associated with increased information level for all psychosocial services at t1 and t2 (all p < .001), increased use in some of these services at t1 and t2, respectively (p ≤ .02), and better evaluation of access (e.g., more recommendations for services provided by physicians, p < .01). At t2, the intervention was associated with a lower level of satisfaction with disease-related information (p = .02). CONCLUSIONS: EPAS may improve information about psychosocial services as well as utilization of and access to these services. The effect on information level seems not to be generalizable to other aspects of oncological care. Future studies should incorporate novel technologies and condense the procedure to its core factors. IMPLICATIONS FOR CANCER SURVIVORS: The screening may help to enhance self-management competencies among cancer survivors. TRIAL REGISTRATION: The trial was retrospectively registered (2/2021) at ClinicalTrials.gov (number: NCT04749056).

Influence of gender on cytokine induced depression and treatment: Gender aspects of IFN-α-induced depression.

BACKGROUND: Cytokine treatment with Interferon-alpha (IFN-α) represents a clinical model of immune associated depression, but it remains unclear if it is of the same entity as major depressive disorder (MDD). The study focuses on possible gender differences in IFN-α induced depression and effects of a pre-emptive antidepressant treatment. METHODS: Data from 181 patients with chronic hepatitis C infection (cHC) without history of mental illnesses undergoing treatment with IFN-α 2a and ribavirin were re-analyzed for gender effects. Patients with a pre-emptive antidepressant therapy with Escitalopram (n = 90, verum group) to prevent IFN-induced depression were compared to patients who received placebo (n = 91). Depressive symptoms before and during HCV-treatment were assessed using the Montgomery-Asberg Depression Rating Scale (MADRS), Beck's Depression Inventory (BDI) and the Hamilton Anxiety Rating Scale. RESULTS: We found significant differences regarding the incidence and severity of depressive symptoms between men and women for patients without antidepressant pre-treatment (placebo group). Significantly more women without pre-emptive antidepressant therapy suffered from clinically relevant depression (MADRS values ≥ 13, p = 0.041) and self-rated depressive symptoms (BDI ≥ 17, p = 0.024). Antidepressant pre-treatment showed comparable effects regarding the reduction of incidence and severity of depression in both women and men. CONCLUSIONS: Compared to MDD, IFN-alpha-induced depression in patients with cHC is also characterized by gender differences with an increased risk for women but no gender difference regarding the effects of an antidepressant pre-treatment is found. Our data strengthens the hypothesis that Interferon-induced depression serves as a clinical model for immune related depressive disorders.

Anxiety and fear of cancer recurrence and its association with supportive care needs and health-care service utilization in cancer patients.

PURPOSE AND METHODS: We investigated the relationship between fear of cancer recurrence (FCR), anxiety, supportive care needs, and utilization of health-care services in a mixed sample of 335 cancer patients. We used validated questionnaires including the Fear of Progression Questionnaire-Short Form (FoP-Q-SF), the General Anxiety Disorder Scale (GAD-7) and the Supportive Care Needs Survey (SCNS-SF34). Health-care services utilization was measured by a self-constructed questionnaire recording the use of 22 health and supportive care offers. RESULTS: In our sample, 3.9% of patients were classified as having high anxiety and 5.1% had high FCR. Patients reported the highest unmet supportive care needs in the domain health system and information followed by psychological needs. Integrated care and complementary support services were the most frequently used (32%) followed by medical (31%), psychological (23%), spiritual and religious (8%) and other support services (9%). Whereas anxiety was related to both unmet psychological and physical/daily living needs (p < 0.01), FCR was associated with unmet supportive care needs in all five domains further including needs with regard to health system and information, patient care, and sexuality (p < 0.01). However, higher levels of anxiety and FCR were not related to higher utilization of health-care services. CONCLUSION: Our findings show that FCR plays a significant role in unmet supportive care needs in cancer patients but not for health-care service utilization. IMPLICATIONS FOR CANCER SURVIVORS: We recommend that clinicians monitor supportive care needs in patients struggling with FCR and anxiety.