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Purpose: The purpose of this study is to investigate changes over time in quality of life (QoL) in incurable lung cancer patients and the impact of determinants like molecular alterations (MA). Methods: In a prospective, longitudinal, multicentric study, we assessed QoL, symptom burden, psychological distress, unmet needs, and prognostic understanding of patients diagnosed with incurable lung cancer at the time of the diagnosis (T0) and after 3 (T1), 6 (T2) and 12 months (T3) using validated questionnaires like FACT-L, National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT), PHQ-4, SCNS-SF-34, and SEIQoL. Results: Two hundred seventeen patients were enrolled, 22 (10%) with reported MA. QoL scores improved over time, with a significant trend for DT, PHQ-4, and SCNS-SF-34. Significant determinants for stable or improving scores over time were survival > 6 months, performance status at the time of diagnosis, and presence of MA. Patients with MA showed better QoL scores (FACT-L at T1 104.4 vs 86.3; at T2 107.5 vs 90.0; at T3 100.9 vs 92.8) and lower psychological distress (NCCN DT at T1 3.3 vs 5; at T2 2.7 vs 4.5; at T3 3.7 vs 4.5; PHQ-4 at T1 2.3 vs 4.1; at T2 1.7 vs 3.6; at T3 2.2 vs 3.6), but also a worsening of the scores at 1 year and a higher percentage of inaccurate prognostic understanding (27 vs 17%) compared to patients without MA. Conclusion: Patients with tumors harboring MA are at risk of QoL deterioration during the course of the disease. Physicians should adapt their communication strategies in order to maintain or improve QoL.

Aims Annual opportunistic screening for cervical carcinoma has been done in Germany since 1971. The creation of this S3 guideline meets an important need, outlined in the National Cancer Plan, with regard to screening for cervical cancer, as this guideline aims to provide important information and support for planned organized screening for cervical cancer in Germany. Methods With the financial support of German Cancer Aid, 21 professional societies developed evidence-based statements and recommendations (classified using the GRADE system) for the screening, management and treatment of precancerous conditions of the cervix. Two independent scientific institutes compiled systematic reviews for this guideline. Recommendations The second part of this short summary deals with the triage, treatment and follow-up care of cervical dysplasia. With regard to those women who do not participate in screening, the guideline authors recommend sending out repeat invitation letters or an HPV self-collection kit. Colposcopy should be carried out for further investigation if cytology findings are Pap II-p and HPV test results are positive or if the results of an HPV 16 or HPV 18 screening test are positive. A single abnormal Pap smear should be triaged and investigated using HPV testing or p16/Ki67 dual staining.

Additional file 1. Exemplary screenshots of the Optimune programme, showing exemplary content of the four domains covered in Optimune.

Background: We aimed to analyze preferred and perceived levels of patients’ involvement in treatment decision-making in a representative sample of cancer patients. Material and Methods: We conducted a multicenter, epidemiological cross-sectional study with a stratified random sample based on the incidence of cancer diagnoses in Germany. Data were collected between January 2008 and December 2010. Analyses were undertaken between 2017 and 2019. We included 5889 adult cancer patients across all cancer entities and disease stages from 30 acute care hospitals, outpatient facilities, and cancer rehabilitation clinics in five regions in Germany. We used the Control Preferences Scale to assess the preferred level of involvement and the nine-item Shared Decision-Making Questionnaire to assess the perceived level of involvement. Results: About 4020 patients (mean age of 58 years, 51% female) completed the survey. Response rate was 68.3%. About a third each preferred patient-led, shared, or physician-led decision-making. About 50.7% perceived high levels, about a quarter each reported moderate (26.0%) or low (24.3%) levels of shared decision-making. Sex, age, relationship status, education, health care setting, and tumor entity were linked to preferred and/or perceived decision-making. Of those patients who preferred active involvement, about 50% perceived high levels of shared decision-making. Conclusion: The majority of patients with cancer wanted to be involved in medical decisions. Many patients perceived a high level of shared decision-making. However, many patients’ level of involvement did not fit their preference. This study provides a solid basis for efforts to improve shared decision-making in German cancer care.

Additional file 2. SPIRIT 2013 checklist: recommended items to address in a clinical trial protocol and related documents.

Background: Shared decision-making is especially relevant in cancer care. Previous studies focused on single cancer entities and/or used small samples to gain insight into treatment decision-making processes in oncology. Aim: The aim of this study was to analyze the preferred and perceived[for full text, please go to the a.m. URL], 17. Deutscher Kongress für Versorgungsforschung (DKVF)

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that is inevitably fatal. To be diagnosed with a terminal illness such as ALS deeply affects one’s personal existence and goes along with significant changes regarding the physical, emotional, and social domains of the patients’ life. ALS patients have to face a rapidly debilitating physical decline which restrains mobility and impairs all activities of daily living. This progressive loss of autonomy may lead to a sense of hopelessness and loss of quality of life, which in turn may even result in thoughts about physician-assisted suicide. Here, we would like to propose a psychotherapeutic manualized, individual, semi-structured intervention to relieve distress and promote psychological well-being in ALS patients. This short-term intervention was originally developed for advanced cancer patients. “Managing Cancer and Living Meaningfully (CALM)” focuses on the four dimensions: (i) symptom management and communication with healthcare providers, (ii) changes in self and relations with close others, (iii) spirituality, sense of meaning and purpose and (iv) thinking of the future, hope, and mortality. We suggest to supplement the concept by two additional dimensions which take into account specific issues of ALS patients: (v) communication skills, and (vi) emotional expression and control. This therapeutic concept named “ManagIng Burden in ALS and Living Meaningfully (mi-BALM)” may be a further treatment option to help improving quality of life of ALS patients.

Background Similar to most solid tumors, the incidence of hematologic malignancies has been rising. Although the median age at diagnosis is about 70 years, little is known about psychosocial aspects and comorbid conditions in elderly patients with hematologic cancers. The main objectives of our study are to assess the prevalence of psychological distress, chronic conditions, functional disabilities, and quality of life in both elderly hematologic cancer patients aged ≥70 years and an age-matched comparison sample of the general population. Methods We conduct a prospective study with three measuring points (t_1: ≥5 years after first time hematologic cancer diagnosis / relapse; t_2 and t_3 six months and 1 year after t_1). In addition, we use a cross sectional study design to recruit a comparison sample of the general population matched by age and sex. Both samples, patients and the comparison group complete validated questionnaires measuring psychological distress, chronic conditions, functional disabilities, and quality of life as well as health care needs and health care utilization. Discussion Our study will provide both a data set offering detailed information about elderly hematologic cancer patients’ physical, psychological and demographic characteristics, and reference data of the elderly general population. Furthermore, the study will provide important information for the development and implementation of psychooncological support offers and survivorship care plans.

BMC psychiatry 16, 22 (2016). doi:10.1186/s12888-016-0728-6, Published by BioMed Central, London

In addition to the healing and alleviation of primary somatic cancer symptoms, the comprehensive psycho oncological treatment of cancer patients is an important and fundamental component of oncological rehabilitation in Germany. Rehabilitation treatment encompasses medical, physiotherapeutic, psychological, and creative therapeutic methods, as well as psycho-educational interventions within the framework of an individualized therapy plan. Psycho-oncological interventions within rehabilitation are governed less by individual therapeutic schools of thought, and more by a supportive, patient-centered approach that integrates various psychotherapeutic methods. Adapted methods and techniques from various psychotherapeutic approaches (behavioral therapy, psychoanalytical psychotherapies, systemic family therapy, or hypnotherapy) are currently used in the treatment of cancer patients. A total of N=116 patients of the Paracelsus Clinic am See in Bad Gandersheim were able to be included in the study. In summary, this study shows that about two thirds of the patients admitted to the oncological rehabilitation clinic exhibit middle to high degrees of distress in the areas of anxiety and/or depression. Moreover, it appears to be particularly important to assess not only the mental distress of cancer patients but also their degree of information with regard to psycho-oncological treatment when performing screening for psycho-oncological treatment outside of the rehabilitation clinic setting. Here it is particularly important to accommodate for a differing need for differing forms of treatment (need for counseling, care, or treatment)., Sveobuhvatno psiho-onkološko liječenje bolesnika s rakom važan je prilog u liječenju i ublažavanju primarnih somatskih simptoma te temeljna komponenta onkološke rehabilitacije u Saveznoj Republici Njemačkoj. Ova vrsta rehabilitacije obuhvaća medicinske, fizioterapijske, psihološke te kreativno terapijske pristupe, ali i psihoedukacijske intervencije u okviru individualiziranih terapijskih programa. Psiho-onkološki rehabilitacijski postupci manje su određeni kognitivnim psihoterapijskim metodma, a više potpornim, pacijentu usmjerenim pristupima koji obuhvaćaju različite psihoterapijske tehnike. Prilagođene metode i tehnike iz različitih psihoterapijskih pristupa (bihevioralna terapija, psihoanalitička psihoterapija, sistemska obiteljska terapija ili hipnoterapija) predstavljaju suvremeni koncept u liječenju onkoloških bolesnika. Ova studija provedena je na uzorku od 116 pacijenata Paracelsus Clinic am See u Bad Gandersheimu. Rezultati studije pokazali su da dvije trećine pacijenata uključenih u onkološku rehabilitaciju pokazuje srednji do visok stupanj poremećaja u području anksioznosti i/ili depresije. Osim toga, osobito je važno da se u uvjetima definiranja psiho-onkološkog liječenja u izvankliničkim uvjetima ne procjenjuje samo vrsta i stupanj psihičkog poremećaja, već također i razina informiranosti o psiho-onkološkom liječenju. U tom smislu posebno je važno različite oblike liječenja prilagoditi različitim osobnim potrebamabolesnika (npr. potreba za savjetovanjem, njegom, liječenjem).

Objective To evaluate the accuracy of the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D) to screen for major depression among people with physical health problems. Design Systematic review and individual participant data meta-analysis. Data sources Medline, Medline In-Process and Other Non-Indexed Citations, PsycInfo, and Web of Science (from inception to 25 October 2018). Review methods Eligible datasets included HADS-D scores and major depression status based on a validated diagnostic interview. Primary study data and study level data extracted from primary reports were combined. For HADS-D cut-off thresholds of 5-15, a bivariate random effects meta-analysis was used to estimate pooled sensitivity and specificity, separately, in studies that used semi-structured diagnostic interviews (eg, Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders), fully structured interviews (eg, Composite International Diagnostic Interview), and the Mini International Neuropsychiatric Interview. One stage meta-regression was used to examine whether accuracy was associated with reference standard categories and the characteristics of participants. Sensitivity analyses were done to assess whether including published results from studies that did not provide raw data influenced the results. Results Individual participant data were obtained from 101 of 168 eligible studies (60%; 25 574 participants (72% of eligible participants), 2549 with major depression). Combined sensitivity and specificity was maximised at a cut-off value of seven or higher for semi-structured interviews, fully structured interviews, and the Mini International Neuropsychiatric Interview. Among studies with a semi-structured interview (57 studies, 10 664 participants, 1048 with major depression), sensitivity and specificity were 0.82 (95% confidence interval 0.76 to 0.87) and 0.78 (0.74 to 0.81) for a cut-off value of seven or higher, 0.74 (0.68 to 0.79) and 0.84 (0.81 to 0.87) for a cut-off value of eight or higher, and 0.44 (0.38 to 0.51) and 0.95 (0.93 to 0.96) for a cut-off value of 11 or higher. Accuracy was similar across reference standards and subgroups and when published results from studies that did not contribute data were included. Conclusions When screening for major depression, a HADS-D cut-off value of seven or higher maximised combined sensitivity and specificity. A cut-off value of eight or higher generated similar combined sensitivity and specificity but was less sensitive and more specific. To identify medically ill patients with depression with the HADS-D, lower cut-off values could be used to avoid false negatives and higher cut-off values to reduce false positives and identify people with higher symptom levels. Fil: Wu, Yin. School Of Medicine; Canadá. Lady Davis Institute For Medical Research; Canadá Fil: Levis, Brooke. Keele University; Reino Unido Fil: Sun, Ying. Lady Davis Institute For Medical Research; Canadá Fil: He, Chen. Lady Davis Institute For Medical Research; Canadá Fil: Krishnan, Ankur. Lady Davis Institute For Medical Research; Canadá Fil: Neupane, Dipika. Lady Davis Institute For Medical Research; Canadá Fil: Bhandari, Parash Mani. Lady Davis Institute For Medical Research; Canadá Fil: Negeri, Zelalem. Université Mcgill; Canadá. Lady Davis Institute For Medical Research; Canadá Fil: Benedetti, Andrea. Centre Universitaire de Santé Mcgill; Canadá Fil: Thombs, Brett D.. Mcgill Faculty Of Medicine And Health Sciences; Canadá. Lady Davis Institute For Medical Research; Canadá Fil: Daray, Federico Manuel. Universidad de Buenos Aires. Facultad de Medicina. Instituto de Farmacologia; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina

Background: This prospective study was conducted to assess changes in quality of life (QoL) of patients who undergo a partial laryngectomy (PLE). Methods: The European Organization for Research and Treatment of Cancer questionnaires QLQ-C30 and QLQ-H&N35 were used pre-procedure (n=218), one week (n=159), three months (n=122) and one year after PLE (n=88). Changes over time were analyzed with the Wilcoxon-signed-rank-test and the Holm-Bonferroni-method, and interpreted regarding clinical relevance. Results: Most subscales worsened one week post-procedure, but many recovered to baseline level after one year. Dyspnea and cognitive functioning deteriorated over time, with worst scores recorded after one year. Financial difficulties and fatigue increased after surgery and maintained that level throughout the follow-up period; sticky saliva remained worse than at baseline, despite some improvements over time. Conclusions: The discovered limitations of QoL should be observed more closely during follow-up treatment, and patients should be informed about these potential eaffects before PLE.:1 Einführung ........................................................................................................... 3 1.1 Das Larynxkarzinom ......................................................................................... 3 1.2 Therapiemöglichkeiten des Larynxkarzinoms ................................................... 4 1.3 Lebensqualität ................................................................................................... 5 1.4 Methodik bei der Evaluierung von Lebensqualität ............................................. 7 1.5 Lebensqualität bei Krebspatienten .................................................................... 8 1.6 Lebensqualität nach Therapie von Kopf-Hals-Tumoren .................................. 10 2 Zielstellung der Studie ....................................................................................... 13 3 Publikation ......................................................................................................... 14 4 Zusammenfassung ............................................................................................ 37 4.1 Einführung....................................................................................................... 38 4.2 Methoden ........................................................................................................ 39 4.3 Ergebnisse ...................................................................................................... 39 4.4 Diskussion....................................................................................................... 41 5 Literaturverzeichnis ............................................................................................ 44 6 Anlagen ............................................................................................................. 49 6.1 Darstellung des eigenen Beitrags ................................................................... 49 6.2 Selbstständigkeitserklärung ............................................................................ 50

Hintergrund: In Deutschland leben derzeit über eine Million Menschen mit Demenz, welche vorrangig von ihren Angehörigen versorgt werden. Diese Pflege und Betreuung ist für den pflegenden Angehörigen mit erheblichen Belastungen insbesondere auf der psychischen, physischen und sozialen Ebene verbunden. Daher ist es notwendig geeignete Interventionen zur Stärkung und Entlastung der pflegenden Angehörigen zu etablieren und diese in die Versorgungslandschaft zu implementieren. Ziel der Untersuchung: Ziel der Arbeit war es, zu überprüfen, ob sich durch eine zugehende Multikomponentenintervention für pflegende Angehörige von Menschen mit Demenz, im Vergleich zum Angebot der Regelversorgung, die subjektiv empfundene Belastung der pflegenden Angehörigen verbessern lässt. Als Intervention wurde das amerikanische REACH II Programm (Resources for Enhance Alzheimer‘ Caregivers Health II) adaptiert. Methode: Die Studie wurde als prospektive randomisiert kontrollierte Studie mit einer Interventions- und einer Kontrollgruppe konzipiert. Rekrutiert wurden pflegende Angehörige von Menschen mit Demenz im Raum Leipzig, die gemeinsam in einem Haushalt wohnten. Die Interventionsgruppe erhielt über einen Zeitraum von sechs Monaten eine zugehende Multikomponentenintervention (DeREACH), welche neun Hausbesuche und drei telefonische Kontakte einschließt. Die Kontrollgruppe wurde im Rahmen der Regelversorgung behandelt. Das primäre Ergebnismaß bezog sich auf die Veränderung der Belastung der pflegenden Angehörigen nach sechs Monaten, gemessen anhand des Zarit Burden Interview. Ergebnisse: In die Studie wurden 92 pflegende Angehörige aufgenommen (Interventionsgruppe n=47, Kontrollgruppe n=45). Für das primäre Ergebnismaß konnten 82 Teilnehmer analysiert werden. Die Belastung reduzierte sich in der Interventionsgruppe nach sechs Monaten um 0,42 (SD=8,42) Skalenpunkte und verstärkte sich in der Kontrollgruppe um 7,05 (SD=8,09) Skalenpunkte. Die zusammengefasste Mittelwertdifferenz beträgt -7,47; KI95% (-11,11; -3,82) und ist zugunsten der Interventionsgruppe statistisch signifikant (p

Hintergrund: Der Zweite Weltkrieg und die damit verbundenen traumatischen Ereignisse können auch Jahrzehnte später bei der ehemaligen Kriegsgeneration Deutschlands mit langfristigen und schwerwiegenden gesundheitlichen Folgen einhergehen. Insbesondere die Erforschung von Langzeitverläufen traumatisierender Erlebnisse befindet sich noch in ihren Anfängen. Ziele: Es werden die Auswirkungen traumatischer Erfahrungen und posttraumatischer Belas-tungssymptomatik auf die heutige gesundheitsbezogene Lebensqualität der älteren Bevölkerung Deutschlands (bis 1948 geboren) untersucht. Die Zusammenhänge werden unter dem Einfluss komorbider Depressivität, somatischer Symptome und körperlicher Erkrankungen analysiert. Material und Methoden: Diese Arbeit untersucht die physische und psychische gesund-heitsbezogene Lebensqualität (SF12v2-Fragebogen zur gesundheitsbezogenen Lebensqua-lität), traumatische Erfahrungen (Traumaliste des M-CIDI), Posttraumatische Belastungsstörung (PTBS) entsprechend des DSM-IV, partielle PTBS (Posttraumatic Diagnostic Scale, PDS), körperliche Erkrankungen (Multimorbiditätsfragebogen), Depressions- und Somatisierungssymptomatik (Patient Health Questionnaire, PHQ-D) in einer repräsentativen Stichprobe der 60-85 jährigen Bevölkerung Deutschlands (N = 1659) mit Hilfe von Selbstbeurteilungsverfahren. Ergebnisse: Personen mit traumatischen Erfahrungen in der Lebensgeschichte berichten eine niedrigere Lebensqualität als Personen ohne traumatische Erfahrungen. Zudem findet sich mit steigender Anzahl der traumatischen Erfahrungen eine niedrigere physische und psychische Lebensqualität. Auch haben Personen mit einer Vollbild- oder partiellen PTBS eine niedrigere körperliche und psychische gesundheitsbezogene Lebensqualität. Beeinträchtigungen in der physischen gesundheitsbezogenen Lebensqualität werden hauptsächlich durch komorbide depressive und somatische Symptome und körperliche Erkrankungen erklärt. Auf die Beeinträchtigungen der psychischen gesundheitsbezogenen Lebensqualität haben sowohl traumatische Erfahrungen und posttraumatische Belastungssymptomatik als auch komorbide Depressions- und Somatisierungssymptomatik Einfluss. Die PTBS führt sowohl bei kategorialer als auch bei dimensionaler Betrachtung zur Beeinträchtigung der gesundheitsbezogenen Lebensqualität; stärkster Einfluss wird auf die psychische Dimension genommen. Schlussfolgerung: Selbst nach Jahrzehnten können potentiell traumatisierende Erlebnisse in der Folge mit erheblichen körperlichen und psychosozialen Beeinträchtigungen einhergehen. Im Umgang mit Älteren sollten neu auftretende oder zunehmende gesundheitliche Beschwerden immer vor dem Hintergrund der historisch-biographischen Perspektive betrachtet werden. Dabei sollte auch subsyndromalen Störungsbildern genügend Beachtung zukommen. Dem Einsatz von Messinstrumenten zur Erfassung der Lebensqualität in der Diagnostik und zur Verlaufsbeurteilung sollte mehr Bedeutung beigemessen werden.

Die vorliegende Promotionsschrift beschäftigt sich mit dem Vergleich der konventionellen EEG-basierten, Polysomnographie mit der hauptsächlich aktivitätsbasierten Aktigraphie mittels des SenseWear® Aktometers. Eine gesunde Probandengruppe, bestehend aus 25 Personen, unterzog sich hierfür einer simultanen Untersuchung mit beiden Methoden im Schlaflabor der Universität Leipzig. Eine korrelationsbasierte Analyse der gewonnen Daten erfasste vor allem die Paramater Gesamtschlafzeit, Schlaflatenz sowie Schlafeffizienz. Im Ergebnis konnte die Arbeitshypothese beibehalten werden. Als kosten- und zeitsparende Alternative ist ein Einsatz des SenseWear® Aktometers zur Erfassung des Schlafes eine verlässliche Alternative gemessen am Goldstandard der Polysomnographie.

Die Studie evaluiert die Arbeit des Ambulanten Hospiz- und Palliativ-Beratungsdienstes (AHPB) am Hospiz Villa Auguste in Leipzig. Der AHPB betreut Palliativpatienten in der Häuslichkeit. Er versteht sich als Hilfe zur Pflegeüberleitung an Schnittstellen der Versorgung (z.B.: Krankenhaus - Entlassung nach Hause). Ziel der Studie war eine wissenschaftliche Begleitung der Arbeit des AHPB. Seine Struktur-, Prozess und Ergebnisqualität wurden evaluiert. Als ein Schwerpunkt der Studie wurde besonders die Rolle der Angehörigen in der häuslichen Versorgung betrachtet. Es wurde auch untersucht, welche Unterstützung sie von der Brückenschwester erfuhren. Im Rahmen der Interviews wurden sie zur Zufriedenheit mit dem Dienst befragt.