[Intended utilization of health care services in cases of mental illnesses with varying urgency]. / Intendierte Inanspruchnahme von Versorgungsangeboten bei psychischen Erkrankungen mit unterschiedlicher Dringlichkeit.

OBJECTIVE: To investigate variations in intended utilization in cases of an acute psychotic episode, an alcohol related or depressive disorder depending on different case characteristics. METHODS: A telephone survey with case vignettes was conducted (N=1,200). Vignettes varied in terms of urgency of symptoms, daytime, sex of the afflicted person and age/mental disorder. The respondents were asked to indicate whom they would contact first in the described case. RESULTS: Outpatient physicians were named most frequently as the first point of contact (61.1%) while only 6.5% of the respondents named emergency medicine including the medical on call service (8.1% in high urgency cases, i. e. emergencies that did not tolerate any delay). Intended utilization varied by urgency and age/mental illness. CONCLUSION: More Information about the need to seek medical help immediately in cases of mental illnesses with high urgency should be provided.

Evaluation of a patient-centered communication skills training for nurses (KOMPAT): study protocol of a randomized controlled trial.

BACKGROUND: To ensure high quality of nurses' communication as part of patient-centered care, training of communication skills is essential. Previous studies indicate that communication skills trainings can improve communication skills of nurses and have a positive effect on emotional and psychological burden. However, most show methodological limitations, are not specifically developed for nurses or were developed for oncological setting only. METHODS: This study aims to evaluate the effectiveness of a needs-based communication skills training for nursing professionals and to derive indications for future implementation. A two-armed randomized controlled trial including components from both effectiveness and implementation research will be applied. Additionally, a comprehensive process evaluation will be carried out to derive indications for future implementation. Nurses (n=180) of a university medical center in Germany will be randomized to intervention or waitlist-control group. The intervention was developed based on the wishes and needs of nurses, previously assessed via interviews and focus groups. Outcomes to measure effectiveness were selected based on Kirkpatrick's four levels of training evaluation and will be assessed at baseline, post-training and at 4-weeks follow-up. Primary outcome will be nurses' self-reported self-efficacy regarding communication skills. Secondary outcomes include nurses' communication skills assessed via standardized patient assessment, knowledge about patient-centered communication, mental and work-related burden, and participants' satisfaction with training. DISCUSSION: To our knowledge, this is the first study systematically evaluating the effectiveness of a patient-centered communication skills training for nursing professionals in Germany. Results will yield insight whether a needs-based intervention can improve nurses' self-efficacy regarding communication skills and other secondary outcomes. TRIAL REGISTRATION: Clinical trial registration number: NCT05700929, trial register: ClinicalTrials.gov (date of registration: 16 November 2022).

Cognitive Deficits in Executive and Language Functions Predict Postoperative Delirium.

OBJECTIVES: Postoperative delirium (POD) remains the most common complication in older adults, with cognitive impairment being the main risk factor. Patients with mild cognitive impairment, in particular, have much to lose from delirium; despite this, their cognitive impairment might be clinically overlooked. Understanding which cognitive domains are particularly predictive in this regard may improve the sensitivity of preoperative testing and allow for a more targeted application of resource-intensive measures to prevent delirium in the perioperative period. The authors conducted this study with the aim of identifying the most indicative cognitive domains. DESIGN: A secondary analysis of a randomized controlled trial. SETTING: At a single center, the University Medical Centre Hamburg in Hamburg, Germany. PARTICIPANTS: Patients ≥60 years without major neurocognitive disorders (dementia, Mini-Mental State Examination score ≤23) scheduled for cardiovascular surgery. MEASUREMENTS AND MAIN RESULTS: Preoperative neuropsychologic testing and delirium screening were performed twice daily until postoperative day 5. A multiple logistic regression model was applied to determine the predictive ability of test performances for the development of delirium. RESULTS: A total of 541 patients were included in the analysis; the delirium rate was 15.6%. After controlling for confounders, only low performance within the Trail Making Test B/A (odds ratio [OR] = 1.32; 95% CI: 1.05-1.66) and letter fluency (OR = 0.66; 95% CI: 0.45-0.96) predicted a particularly high risk for delirium development. The discriminative ability of the final multiple logistic regression model to predict POD had an area under the curve of 0.786. CONCLUSIONS: Impairment in the cognitive domains of executive function and language skills associated with memory, inhibition, and access speed seem to be particularly associated with the development of delirium after surgery in adults ≥65 years of age without apparent preoperative neurocognitive impairment.

Association between periodontitis and depression severity - A cross-sectional study of the older population in Hamburg.

The aim of the current study is to investigate the association between periodontitis (exposure variable) and depression severity (outcome variable) in an older German population. We evaluated data from 6,209 participants (median age 62 years) of the Hamburg City Health Study (HCHS). The HCHS is a prospective cohort study and is registered at ClinicalTrial.gov (NCT03934957). Depression severity were assessed with the 9-item Patient Health Questionnaire (PHQ-9). Periodontal examination included probing depth, gingival recession, plaque index, and bleeding on probing. Descriptive analyses were stratified by periodontitis severity. Multiple linear regression models were adjusted for age, sex, diabetes, education, smoking, and antidepressant medication. Linear regression analyses revealed a significant association between log-transformed depression severity and periodontitis when including the interaction term for periodontitis * age, even after adjusting for age, sex, diabetes, education, smoking and antidepressant medication. We identified a significant association between severe periodontitis and elevated depression severity, which interacts with age. Additionally, we performed a linear regression model for biomarker analyses, which revealed significant associations between depression severity and severe periodontitis with log-transformed inflammatory biomarkers interleukin 6 (IL-6) and high-sensitivity C-reactive protein (hsCRP). In order to identify new therapeutic strategies for patients with depression and periodontal disease, future prospective studies are needed to assess the physiological and psychosocial mechanisms behind this relationship and the causal directionality.

Factors influencing the implementation of shared decision-making in breast cancer care: protocol for a mixed-methods study.

INTRODUCTION: Chile is committed to actively involving patients in their healthcare. However, little is known about how this is translated into clinical encounters. Breast cancer (BC) is the first cause of cancer-related death in Chilean women. National policy guarantees standard care, and treatment decisions should be made along this process that can have long-term consequences for women. So, BC is a particularly well-suited case study to understand the complexity of patient participation in decision-making. OBJECTIVE: To identify the factors that affect the active involvement of patients in the BC treatment decision-making process, considering the perspectives and practices of health professionals and women facing the disease. METHOD AND ANALYSIS: We will conduct a mixed-method study through a convergent parallel design in three stages: (1) A qualitative study: non-participant observation of the tumour board (TB) meetings; semi-structured interviews with key informants from TBs; documentary analyses; semi-structured interviews with women facing BC; and non-participant observations of clinical encounters; (2) a cross-sectional study with 445 women facing BC stages I-III from three hospitals in Santiago, Chile. We will measure the level of expected participation, experienced participation, decisional conflict, quality of life (QoL) and satisfaction with healthcare. Descriptive analysis will be performed, and multivariable binary logistic regression models will be adjusted to identify factors associated with high levels of QoL or satisfaction; (3) an integration study will bring together the data through a joint display technique. ETHICS AND DISSEMINATION: The study has been conceived and will be conducted according to international and local agreements for ethical research. Ethical approval has been granted by two Ethics Committees in Chile.The results will be disseminated to scientific and lay audiences (publications in scientific journals and conferences, seminars and a website for plain language dissemination).

Higher comorbidity burden is associated with lower self-reported quality of life after stroke.

Introduction: This study assesses the association of comorbidity burden and polypharmacy with self-reported quality of life after stroke. Patients and methods: We performed a post-hoc analysis of a prospective, single-center, observational study of outcome evaluation by patient-reported outcome measures in stroke clinical practice. Consecutive patients with acute ischemic stroke (AIS) were enrolled and self-reported health-related quality of life (HrQoL) was assessed 90 days after acute stroke using the Patient-reported Outcomes Measurement Information System 10-Question Short-Form (PROMIS-10). Comorbidities at baseline were assessed by the Charlson Comorbidity Index (CCI). Polypharmacy was defined as medication intake of ≥5 at baseline. We used linear regression analysis to study the association of CCI, polypharmacy and other clinical covariates with HrQoL after stroke. Results: Of 781 patients (median age 76 years, 48.4% female) enrolled, 30.2% had a CCI Score ≥2, and 31.5% presented with polypharmacy. At follow up, 71 (9.1%) had died. In 409 (52.4%) reached for outcome evaluation, Global Physical Health T-Score was 43.8 ± 10 and Global Mental Health T-Score was 43.5 ± 8.76, indicating lower HrQoL than the average population. A CCI Score ≥2, higher NIHSS Score, female sex, dependency on others for dressing, toileting and mobility before index stroke, atrial fibrillation and hypertension were independent predictors of worse physical and mental health outcomes, while polypharmacy was not. Conclusion: In patients with AIS, high comorbidity burden and polypharmacy are frequent. Comorbidity burden at admission is independently associated with worse self-reported physical and mental health three months after stroke.

Effects of walking impairment on mental health burden, health risk behavior and quality of life in patients with intermittent claudication: A cross-sectional path analysis.

INTRODUCTION: Intermittent claudication is the leading symptom of peripheral artery disease (leg pain when walking). The present study investigates the extent to which walking impairment is associated with health-related quality of life, mental health and health risk behavior. METHODS: A theory-based, cross-sectional path model was empirically examined using pre-intervention baseline data from a multicenter, randomized-controlled trial of patients with intermittent claudication (PAD-TeGeCoach). Data were available from 1 696 patients who completed a battery of questionnaires between April 14, 2018 and March 12, 2019, including measures of walking impairment (Walking Impairment Questionnaire), health-related quality of life (SF-12), mental burden (GAD-7, PHQ-9), nicotine- and alcohol-related risk behavior (Fagerström-Test, AUDIT-C). Sociodemographic characteristics and comorbid conditions were included in the postulated model a priori to minimize confounding effects. RESULTS: Walking impairment was associated with an increase in depressive (ß = -.36, p < .001) and anxiety symptoms (ß = -.24, p < .001). The prevalence of depressive and anxiety symptoms was 48.3% and 35.5%, respectively, with female patients and those of younger age being at greater risk. Depressive symptoms were predictive of an increased tobacco use (ß = .21; p < .001). Walking impairment had adverse effects on physical quality of life, both directly (ß = .60, p < .001) and indirectly mediated through depressive symptoms (ß = -.16, p < .001); and indirectly on mental quality of life mediated through depressive (ß = -.43, p < .001) and anxiety symptoms (ß = -.35, p < .001). DISCUSSION: The findings underscore the need for a comprehensive treatment strategy in patients with intermittent claudication. Measures to improve walking impairment (e.g. exercise training) are key to enhance quality of life and should be the primary treatment. As a key mediator of mental quality of life, depressive and anxiety symptoms should be addressed by rigorously including mental health treatment. Risky health behaviors should be approached by promoting behavior change (e.g. smoking cessation) as a secondary prevention of peripheral artery disease.

Moving towards patient-centered care and shared decision-making in Germany.

The main focus of this paper is to describe the development and current state of policy, research and implementation of patient-centered care (PCC) and shared decision-making (SDM) in Germany. What is the current state in health policy? Since 2013, the Law on Patients' Rights has standardized all rights and responsibilities regarding medical care for patients in Germany. This comprises the right to informed decisions, comprehensive and comprehensible information, and decisions based on a clinician-patient partnership. In addition, reports and action plans such as the German Ethics Council's report on patient well-being, the National Health Literacy Action Plan, or the National Cancer Plan emphasize and foster PCC and SDM on a policy level. There are a number of public organizations in Germany that support PCC and SDM. How are patients and the public involved in health policy and research? Publishers and funding agencies increasingly demand patient and public involvement. Numerous initiatives and organizations are involved in publicizing ways to engage patients and the public. Also, an increasing number of public and research institutions have established patient advisory boards. How is PCC and SDM taught? Great progress has been made in introducing SDM into the curricula of medical schools and other health care providers' (HCPs) schools (e.g., nursing, physical therapy). What is the German research agenda? The German government and other public institutions have constantly funded research programs in which PCC and SDM are important topics. This yielded several large-scale funding initiatives and helped to develop SDM training programs for HCPs in different fields of health care and information materials. Recently, two implementation studies on SDM have been conducted. What is the current uptake of PCC and SDM in routine care, and what implementation efforts are underway? Compared to the last country report from 2017, PCC and SDM efforts in policy, research and education have been intensified. However, many steps are still needed to reliably implement SDM in routine care in Germany. Specifically, the further development and uptake of decision tools and countrywide SDM trainings for HCPs require further efforts. Nevertheless, an increasing number of decision support tools - primarily with support from health insurance funds and other public agencies - are to be implemented in routine care. Also, recent implementation efforts are promising. For example, reimbursement by health insurance companies of hospital-wide SDM implementation is being piloted. A necessary next step is to nationally coordinate the gathering and provision of the many PCC and SDM resources available.

Development and content validity of the Experienced Patient-Centeredness Questionnaire (EPAT)-A best practice example for generating patient-reported measures from qualitative data.

INTRODUCTION: To effectively foster patient-centeredness (PC), it is crucial to measure its implementation. So far, there is no German measure to assess PC comprehensively. The aim of this study is to develop and select items for the Experienced Patient-Centeredness (EPAT) Questionnaire, a patient-reported experience measure (PREM). The EPAT intends to assess PC from the perspective of adult patients treated for different chronic diseases in inpatient and outpatient settings in Germany. Furthermore, we aim at providing a best-practice example for developing PREMs from qualitative data. METHODS: The development process comprised a three-phase mixed-method design: (1) preparation, (2) item generation and (3) item selection and testing of content validity. We generated items using qualitative content analysis based on information from focus groups, key informant interviews and literature search. We selected items using relevance rating and cognitive interviews. Participants were patients from four chronic disease groups (cancer, cardiovascular disease, mental disorder, musculoskeletal disorder) and healthcare experts (e.g., clinicians, researchers, patient representatives). RESULTS: We conducted six focus groups with a total of 40 patients, key informant interviews with 10 experts and identified 48 PREMs from international literature. After team discussion, we reached a preliminary pool of 152 items. We conducted a relevance rating with 32 experts and 34 cognitive interviews with 21 patients. We selected 125 items assessing 16 dimensions of PC and showed high relevance and comprehensibility. CONCLUSIONS: The EPAT questionnaire is currently undergoing psychometric testing. The transparent step-by-step report provides a best practice example that other researchers may consider for developing PREMs. Integrating literature and experts with a strong focus on patient feedback ensured good content validity. The EPAT questionnaire will be helpful in assessing PC in routine clinical practice in inpatient and outpatient settings for research and quality improvement. PATIENT OR PUBLIC CONTRIBUTION: Patients were not involved as active members of the research team. While developing the funding proposal, we informally reached out to several patient organizations who all gave us positive feedback on the study aims, thereby confirming their relevance. Those patient organizations endorsed the funding proposal with formal letters of support and supported recruitment by disseminating advertisements for study participation.

Prevalence of mental disorders in patients with cancer compared to matched controls - secondary analysis of two nationally representative surveys.

AIM: To compare prevalence rates of mental disorders in patients with cancer and general population controls. METHOD: In two stratified nationally representative surveys, the 12-month prevalence of mental disorders was assessed in 2141 patients with cancer and 4883 general population controls by the standardized Composite International Diagnostic Interview (CIDI). We determined odds ratios (ORs) to compare the odds for mental disorders (combined and subtypes) in cancer patients with age- and gender-matched controls. RESULTS: The 12-month prevalences rate for any mental disorder was significantly higher in patients with cancer compared to controls (OR 1.28, 95% CI 1.14-1.45). Prevalence rates were at least two times higher for unipolar mood disorders (major depression: OR 2.07, 95% CI 1.71-2.51; dysthymia: OR 2.93, 95% CI 2.13-4.02) and mental disorders due to a general medical condition (OR 3.31, 95% CI 2.32-4.71). There was no significant elevation for anxiety disorders overall (OR 0.95, 95% CI 0.81-1.11). Mildly elevated prevalence rates emerged for post-traumatic stress disorder (OR 1.57, 95% CI 1.11-2.23) and social phobia (OR 1.57, 95% CI 1.07-2.31), while specific phobia (OR 0.82, 95% CI 0.67-1.00) and agoraphobia (OR 0.49, 95% CI 0.33-0.73) were significantly less frequent in cancer. CONCLUSIONS: While elevated depression rates reinforce the need for its systematic diagnosis and treatment, lower prevalences were unexpected given previous evidence. Whether realistic illness-related fears and worries contribute to lower occurrence of anxiety disorders with excessive fears in cancer may be of interest to future research.

Evaluation of a program for routine implementation of shared decision-making in cancer care: results of a stepped wedge cluster randomized trial.

BACKGROUND: Shared decision-making (SDM) is preferred by many patients in cancer care. However, despite scientific evidence and promotion by health policy makers, SDM implementation in routine health care lags behind. This study aimed to evaluate an empirically and theoretically grounded implementation program for SDM in cancer care. METHODS: In a stepped wedge design, three departments of a comprehensive cancer center sequentially received the implementation program in a randomized order. It included six components: training for health care professionals (HCPs), individual coaching for physicians, patient activation intervention, patient information material/decision aids, revision of quality management documents, and reflection on multidisciplinary team meetings (MDTMs). Outcome evaluation comprised four measurement waves. The primary endpoint was patient-reported SDM uptake using the 9-item Shared Decision Making Questionnaire. Several secondary implementation outcomes were assessed. A mixed-methods process evaluation was conducted to evaluate reach and fidelity. Data were analyzed using mixed linear models, qualitative content analysis, and descriptive statistics. RESULTS: A total of 2,128 patient questionnaires, 559 questionnaires from 408 HCPs, 132 audio recordings of clinical encounters, and 842 case discussions from 66 MDTMs were evaluated. There was no statistically significant improvement in the primary endpoint SDM uptake. Patients in the intervention condition were more likely to experience shared or patient-lead decision-making than in the control condition (d=0.24). HCPs in the intervention condition reported more knowledge about SDM than in the control condition (d = 0.50). In MDTMs the quality of psycho-social information was lower in the intervention than in the control condition (d = - 0.48). Further secondary outcomes did not differ statistically significantly between conditions. All components were implemented in all departments, but reach was limited (e.g., training of 44% of eligible HCPs) and several adaptations occurred (e.g., reduced dose of coaching). CONCLUSIONS: The process evaluation provides possible explanations for the lack of statistically significant effects in the primary and most of the secondary outcomes. Low reach and adaptations, particularly in dose, may explain the results. Other or more intensive approaches are needed for successful department-wide implementation of SDM in routine cancer care. Further research is needed to understand factors influencing implementation of SDM in cancer care. TRIAL REGISTRATION: clinicaltrials.gov, NCT03393351 , registered 8 January 2018.

Thoughts of death and suicidality among patients with cancer: Examining subtypes and their association with mental disorders.

OBJECTIVE: Cancer is associated with an increased risk for completed suicide. We explored subtypes of thoughts of death, death wishes, suicidal ideation and behavior and their association with mental disorders and demographic and disease-related characteristics. METHODS: We studied 2,141 cancer patients with the standardized Composite International Diagnostic Interview-Oncology (CIDI-O). Assessment included 4-weeks-prevalences of thoughts of death, wish to die, suicidal ideation, suicide plans, and lifetime suicide attempts. We further assessed 4-weeks-prevalences of mood, anxiety, adjustment, somatoform, substance use, and disorders due to general medical condition. We conducted latent class analyses (LCA). RESULTS: The LCA identified three classes with distinct patterns of suicidality. Class 1 (89.0% of the sample) showed no suicidality. Class 2 (6.9%) was characterized by thoughts of death without suicidal ideation. Class 3 (4.1%) was characterized by thoughts of death, suicidal ideation, and suicide plans. Death wishes occurred in both classes 2 and 3. Classes 2 and 3 were associated with a significantly higher risk for any mental disorder (OR from 4.22, adjustment disorder, to 10.20, mood disorders, p < 0.001) compared to class 1. Patients with mental disorders were equally likely in classes 2 and 3. Patients with incurable cancer were significantly more likely in class 2, and less likely in class 3. CONCLUSIONS: Cancer patients with suicidal ideation are not distinctly characterized by mental disorders. Further study of concepts that consider problematic adjustment to the cancer stressor such as death anxiety and demoralization may contribute to understand psychological distress underlying subtypes of thoughts of death and suicidality in cancer.

Existential distress in patients with advanced cancer and their caregivers: study protocol of a longitudinal cohort study.

INTRODUCTION: At the end of life, patients with advanced cancer and their informal caregivers may confront multiple existential concerns. Despite the strong potential to alleviate existential distress through psychosocial interventions, existential distress and its impact on healthcare outcomes have not yet been studied systematically. We aim to investigate the frequency, longitudinal trajectory and predictive impact of existential distress on end-of-life outcomes. We further aim to determine patients' and caregivers' specific need for and utilisation of psychosocial support for existential distress. METHODS: This longitudinal cohort study will consecutively recruit 500 patients with advanced cancer and 500 caregivers from oncological outpatient and inpatient clinics. Participants will complete self-report questionnaires (sociodemographic and disease-related characteristics, existential distress, end-of-life outcomes, resources and support needs) at five points of assessment (at baseline and after 3, 6, 9 and 12 months). At baseline and 6-month follow-up, we will conduct structured diagnostic interviews to assess mental disorders. Statistical analyses will include descriptive statistics to determine the prevalence of existential distress, mental disorders and end-of-life outcomes; multiple linear and logistic regression analyses to calculate the predictive impact of existential distress on end-of-life outcomes; and growth mixture models to analyse longitudinal trajectories of existential distress. DISCUSSION: This study will provide comprehensive knowledge about patients' and caregivers' existential concerns. The longitudinal empirical data will allow for conclusions concerning the frequency and course of existential distress throughout 1 year. This important extension of existing cross-sectional research will contribute to further develop targeted psychosocial interventions. Profiles of existential distress may be applied by clinicians from multiple professions and help to address existential concerns effectively. ETHICS AND DISSEMINATION: The study was approved by the institutional research ethics committee (reference number LPEK-0177). Results will be presented at scientific conferences and published in peer-reviewed journals. Other forms of dissemination will include sharing results on the psychometric properties of the structured demoralisation interview with international research groups and communication with healthcare professionals providing psychosocial treatment for patients and caregivers. Following scientific standards, our progress will be regularly updated on ClinicalTrials.gov. TRIAL REGISTRATION NUMBER: NCT04600206.

Efficacy of a Brief, Peer-Delivered Self-management Intervention for Patients With Rare Chronic Diseases: A Randomized Clinical Trial.

Importance: Patients coping with rare diseases need psychosocial support. Objective: To evaluate the efficacy of a brief, transdiagnostic, peer-delivered intervention for patients with rare diseases in addition to care as usual (CAU) compared with CAU only. Design, Setting, and Participants: In this 2-group randomized clinical trial conducted from October 5, 2017, to July 12, 2019, patients were recruited via specialized clinics and patient organizations across Germany and participated from home. The study included consecutive adult patients with neurofibromatosis type 1, Marfan syndrome, primary sclerosing cholangitis, and pulmonary arterial hypertension who have limited functionality because of the disease. Exclusion criteria were a life-threatening health status and ongoing psychotherapeutic treatment. Of 143 patients screened for eligibility with a semistructured telephone interview, 54 were excluded, and 89 were randomized: 45 patients were randomly allocated to the peer-delivered intervention group, and 44 to the control group; 87 patients (98%) completed the 6-month follow-up assessment. The analysis was performed using an intention-to-treat principle. Data cleansing and analysis were conducted between April 25, 2019, and February 13, 2020. Interventions: The 6-week intervention consisted of a self-help book and telephone-based peer counseling in addition to CAU. The control group received CAU alone. Peer counselors received training, structured consultation guidelines, and supervision. Main Outcomes and Measures: The primary outcome was acceptance of the disease as assessed using the Illness Cognition Questionnaire (ICQ; mean sum scores range from 0 to 18, with higher values representing more acceptance) 6 months after the intervention. Secondary outcomes included self-reported coping strategies (Health Education Impact Questionnaire), illness cognition (ICQ and Illness Perception Questionnaire), depression severity (Patient Health Questionnaire 9-item depression scale), anxiety severity (Generalized Anxiety Disorder Scale), quality of life (12-Item Short-Form Health Survey), and social support (Social Support Questionnaire). Outcomes were assessed before the intervention, after the intervention, and at a 6-month follow-up. Results: The mean (SD) age of the 89 participating patients was 46.3 (14.9) years; 59 (66%) were women. There were no group differences regarding baseline variables. All patients allocated to the intervention group completed the intervention. Six months after the intervention, but not directly after completing the program, the intervention group had significantly higher rates of acceptance (ICQ) of the disease (primary outcome) compared with the CAU group. Mean (SD) baseline ICQ scores were 9.61 (3.79) in the control group and 9.86 (3.40) in the intervention group. Mean (SE) ICQ scores at 6 months were 10.32 (0.42) for the control group and 11.79 (0.42) for the intervention group, with a significant mean difference of -1.47 (95% CI, -2.63 to -0.31; P = .01). Several secondary outcomes, including different coping strategies, social support, and mental quality of life, were significantly higher after the intervention compared with the control group. Conclusions and Relevance: In this randomized clinical trial, a self-help and peer counseling intervention improved patients' acceptance of their rare chronic diseases. Self-management and peer support can efficiently address the unique care needs of patients with rare diseases. Trial Registration: isrctn.org Identifier: ISRCTN13738704.

The role of attachment avoidance: A longitudinal mediation model predicting existential distress in patients with advanced cancer.

OBJECTIVE: Although a protective effect of reliable interpersonal relationships on existential distress has been established, evidence remains inconclusive for attachment insecurity as an underlying factor of persistent psychological distress. We tested a longitudinal model hypothesizing attachment avoidance as a mediator of high demoralization and anxiety over time. METHODS: We studied 206 patients with advanced cancer (mean age = 59.6, 61% female) participating in an intervention trial. Patients completed self-report measures for demoralization, anxiety, perceived relatedness, attachment insecurity, and death anxiety. Our mediated path model included perceived relatedness and death anxiety at baseline as predictors, attachment avoidance at baseline as mediator, and demoralization and anxiety at 6-month follow-up (N = 125) as outcomes. RESULTS: Attachment avoidance partially mediated the relationship between death anxiety and demoralization (ß = 0.07, 95% CI 0.02-0.12) and anxiety (ß = 0.05, 95% CI 0.001-0.10). Findings for perceived relatedness were less conclusive. Its indirect effects through attachment avoidance were significant for both outcomes (demoralization: ß = -0.07, 95% CI -0.13 to -0.02, anxiety: ß = -0.05, 95% CI -0.11 to -0.003). CONCLUSIONS: Due to its trait-like quality, attachment avoidance may play a less central role in explaining the course of existential distress over time than previous research indicated. Addressing change-sensitive relational concerns in psychosocial interventions may be more effective to alleviate existential distress.

Termination rates and histological reclassification of active surveillance patients with low- and early intermediate-risk prostate cancer: results of the PREFERE trial.

PURPOSE: Active surveillance (AS) strategies for patients with low- and early intermediate-risk prostate cancer are still not consistently defined. Within a controlled randomized trial, active surveillance was compared to other treatment options for patients with prostate cancer. Aim of this analysis was to report on termination rates of patients treated with AS including different grade groups. METHODS: A randomized trial comparing radical prostatectomy, active surveillance, external beam radiotherapy and brachytherapy was performed from 2013 to 2016 and included 345 patients with low- and early intermediate-risk prostate cancer (ISUP grade groups 1 and 2). The trial was prematurely stopped due to slow accrual. A total of 130 patients were treated with active surveillance. Among them, 42 patients were diagnosed with intermediate-risk PCA. Reference pathology and AS quality control were performed throughout. RESULTS: After a median follow-up time of 18.8 months, 73 out of the 130 patients (56%) terminated active surveillance. Of these, 56 (77%) patients were histologically reclassified at the time of rebiopsy, including 35% and 60% of the grade group 1 and 2 patients, respectively. No patients who underwent radical prostatectomy at the time of reclassification had radical prostatectomy specimens ≥ grade group 3. CONCLUSION: In this prospectively analyzed subcohort of patients with AS and conventional staging within a randomized trial, the 2-year histological reclassification rates were higher than those previously reported. Active surveillance may not be based on conventional staging alone, and patients with grade group 2 cancers may be recommended for active surveillance in carefully controlled trials only.

Results of a randomized trial of treatment modalities in patients with low or early-intermediate risk prostate cancer (PREFERE trial).

PURPOSE: The optimal treatment for patients with low to early-intermediate risk prostate cancer (PCa) remains to be defined. The randomized PREFERE trial (DRKS00004405) aimed to assess noninferiority of active surveillance (AS), external-beam radiotherapy (EBRT), or brachytherapy by permanent seed implantation (PSI) vs. radical prostatectomy (RP) for these patients. METHODS: PREFERE was planned to enroll 7600 patients. The primary endpoint was disease specific survival. Patients with PCa stage ≤ cT2a, cN0/X, M0, PSA ≤ 10 ng/ml and Gleason-Score ≤ 3 + 4 at reference pathology were eligible. Patients were allowed to exclude one or two of the four modalities, which yielded eleven combinations for randomization. Sixty-nine German study centers were engaged in PREFERE. RESULTS: Of 2251 patients prescreened between 2012 and 2016, 459 agreed to participate in PREFERE. Due to this poor accrual, the trial was stopped. In 345 patients reference pathology confirmed inclusion criteria. Sixty-nine men were assigned to RP, 53 to EBRT, 93 to PSI, and 130 to AS. Forty patients changed treatment shortly after randomization, 21 to AS. Forty-eight AS patients with follow-up received radical treatment. Median follow-up was 19 months. Five patients died, none due to PCa; 8 had biochemical progression after radical therapy. Treatment-related acute grade 3 toxicity was reported in 3 RP patients and 2 PSI patients. CONCLUSIONS: In this prematurely closed trial, we observed an unexpected high rate of termination of AS and an increased toxicity related to PSI. Patients hesitated to be randomized in a multi-arm trial. The optimal treatment of low and early-intermediate risk PCa remains unclear.

Testing the Treatment Integrity of the Managing Cancer and Living Meaningfully Psychotherapeutic Intervention for Patients With Advanced Cancer.

INTRODUCTION: The Managing Cancer and Living Meaningfully (CALM) therapy for patients with advanced cancer was tested against a supportive psycho-oncological counseling intervention (SPI) in a randomized controlled trial (RCT). We investigated whether CALM was delivered as intended (therapists' adherence); whether CALM therapists with less experience in psycho-oncological care show higher adherence scores; and whether potential overlapping treatment elements between CALM and SPI can be identified (treatment differentiation). METHODS: Two trained and blinded raters assessed on 19 items four subscales of the Treatment Integrity Scale covering treatment domains of CALM (SC: Symptom Management and Communication with Health Care Providers; CSR: Changes in Self and Relationship with Others; SMP: Spiritual Well-being and Sense of Meaning and Purpose; FHM: Preparing for the Future, Sustaining Hope and Facing Mortality). A random sample of 150 audio recordings (75 CALM, 75 SPI) were rated on a three-point Likert scale with 1 = "adherent to some extent," 2 = "adherent to a sufficient extent," 3 = "very adherent." RESULTS: All 19 treatment elements were applied, but in various frequencies. CALM therapists most frequently explored symptoms and/or relationship to health care providers (SC_1: n_applied = 62; 83%) and allowed expression of sadness and anxiety about the progression of disease (FHM_2: n_applied = 62; 83%). The exploration of CALM treatment element SC_1 was most frequently implemented in a satisfactory or excellent manner (n_sufficient or very adherent = 34; 45%), whereas the treatment element SMP_4: Therapist promotes acknowledgment that some life goals may no longer be achievable (n_sufficient or very adherent = 0; 0%) was not implemented in a satisfactory manner. In terms of treatment differentiation, no treatment elements could be identified which were applied significantly more often by CALM therapists than by SPI therapists. CONCLUSION: Results verify the application of CALM treatment domains. However, CALM therapists' adherence scores indicated manual deviations. Furthermore, raters were not able to significantly distinguish CALM from SPI, implying that overlapping treatment elements were delivered to patients.