[The Structural Reform of The Psychotherapy Guidelines in Germany]. / Die neuen Behandlungselemente der Psychotherapiestrukturreform.

OBJECTIVES: Our study investigates how psychotherapists implement and assess the newly introduced elements of the structural reform of the psychotherapy guideline in Germany. METHODS: We asked psychotherapists about their experiences with the structural reform in semi-structured interviews. The data was analysed using qualitative content analysis. RESULTS: A total of 37 h of audio material from 41 psychotherapists were available. The interviews showed that acute treatment and relapse prevention are welcomed by psychotherapists. However, due to lack of appointment capacity as well as conceptual barriers, these are rarely used. Concerning psychotherapeutic assessment consultations, the opinions were heterogeneous. CONCLUSION: Individual aspects of the new care elements are assessed positively. However, these can only be implemented to a limited extent and are not sufficient to significantly improve the strained supply situation.

["It's Left a Bitter Taste" Psychotherapists' Perspectives on the Abolition of the German Assessment Procedure for Outpatient Psychotherapy]. / "Es hat so einen etwas bitteren Beigeschmack" Die Abschaffung des Antrags- und Gutachterverfahrens aus Sicht von Psychotherapeut*innen in der ambulanten Versorgung.

BACKGROUND AND RESEARCH QUESTION: In 2019, the abolition and replacement of the present German assessment procedure for outpatient psychotherapy was resolved and adopted into law. This study examined what psychotherapists think about the new plan. METHODS: We conducted semi-guided interviews with psychotherapists about their experience and opinion of the current psychotherapeutic care situation in Germany. Statements about the assessment procedure were evaluated using qualitative text analyses. We compared the psychotherapists' opinion on the assessment procedure with the psychotherapeutic approach as well as the age group. RESULTS: Of 41 psychotherapists 27 reported their thoughts about the assessment procedure. The following themes could be drawn from their statements: Appreciation as well as criticism of quality control of the procedure, worries about a future loss of economic and treatment certainty, perception that the assessment procedure questions one's competence, disapproval of the low remuneration of the reports, the connection between individual attitudes towards the assessment report and conscientiousness in writing the reports, and the lack of transparency of the legislative initiative. Psychodynamic psychotherapists wanted to keep the assessment procedure slightly more often compared to behavioural psychotherapists; child and youth psychotherapists wanted to keep it more often than psychotherapists for adults. DISCUSSION: Psychotherapists perceive the reform of the assessment procedure as a process with a substantial impact on their current clinical practice as well as their psychotherapeutical identity. To improve the quality and acceptance of the future quality assurance procedure, psychotherapists should be an active part of the development process.

[Implementation of a Pilot Project Supporting Parents Suffering from Cancer with Underage Children]. / Implementierung eines Modellprojektes zur phasenübergreifenden Unterstützung von krebskranken Eltern mit minderjährigen Kindern.

OBJECTIVE: Families with one parent suffering from cancer are exposed to extraordinary emotional and organizational burdens, affecting underaged children. To help coordinated access to social and logistic support options and thus reduce the stress on family members, the project Brückenschlag was founded. The aim of this paper was to evaluate the implementation of this pilot project following the healthcare utilization model by Andersen. METHODS: A cross-sectional observational study was conducted using a mixed-method approach. Semi-structured written expert surveys (n=10) and secondary analysis of routine data of the care model (n=171 families) were combined. RESULTS: Quantitative secondary analysis: The participating families had 1-7 children (median (m) 2, range (s) 6). In 66% of the cases, the mother was affected by cancer, in 20% the diseased parent was in a single parent household. The communication structure in these families was rated "limited" to "rather open". Of the total of 171 contacts (study period 9/14 to 11/17), 133 families made use of Brückenschlag; 59.2% of the contacts were made by psycho-oncologists and the social services department of the hospital. If the contact was initiated by the patients themselves or by psycho-oncologists, a guidance was established significantly more frequently (significance of chi-squared test 0.047). Qualitative analysis: There was a lack of awareness and coordination of existing support services and a lack of family resources to use existing support offers. Both the desired and the established support fell primarily in the area of organizational support. Brückenschlag improved networking and took on a navigating function for the families. CONCLUSION: The data collected indicate that in families, matching the German average in their socio-demographic characteristics, a great need for organizational support develops as soon as one parent becomes sick with cancer. The model project Brückenschlag creates an access to support services for families with one parent suffering from cancer.

Family resilience of families with parental cancer and minor children: a qualitative analysis.

Introduction: Estimated 50,000 minor children in Germany experience a newly diagnosed cancer in one of their parents every year. Family resilience has proven to be an important concept against life crises. However, little research exists regarding family resilience in the context of parental cancer with minor children. Based on the "Family Resilience Framework," the aim of the study is to investigate the processes of family resilience of affected families. In addition, we explore which combinations of promoting family resilience processes can be characterized. Methods: As part of the mixed-method quasi-experimental interventional study "F-SCOUT," a qualitative content analysis was used to analyze the documentation of the "Family-Scouts" (a fixed contact person who advises, accompanies, and supports the families). Documentation was performed by families' study inclusion (T0), after 3 months (T1) and 9 months (T2) concerning current family situation, organization of everyday life, emotional coping, open communication within the family, and planned tasks. Results: The N = 73 families had between one and six children. In 58 (79%) families, the mother had cancer. In the course of the analysis, a category system with 10 main categories and 36 subcategories emerged. Family resilience processes were described to different extents. Combinations of categories promoting family resilience were characterized by the use of social resources, flexibility, economic resources, and open communication. Discussion: The findings are consistent with existing assumptions about family resilience in terms of the importance of social resources, family cohesion, mutual support, flexibility, open communication, and psychological well-being. In contrast to the findings of previous research, spirituality, and collaborative problem-solving indicate less centrality here. In turn, the findings on economic resources and information-seeking provide a valuable addition to the family resilience literature in the context of parental cancer with minor children. Clinical trial registration: ClinicalTrials.gov, identifier NCT04186923.

Effectiveness of interprofessional communication skills training for oncology teams: study protocol for a three-arm cluster randomised trial (KommRhein Interpro).

INTRODUCTION: Patient-provider communication is an important factor influencing the quality of care in oncology. The study examines the comparative effectiveness of a 10-hour interprofessional communication skills training (CST) programme for physicians and nurses in cancer centres. METHODS AND ANALYSIS: KommRhein Interpro is a cluster-randomised trial sponsored by the German Cancer Aid (Deutsche Krebshilfe, DKH) and conducted at the cancer centres of the university hospitals of Aachen, Bonn, Cologne and Düsseldorf. Thirty oncology teams of four cancer centres are randomly assigned to three study arms, providing healthcare professionals with either (a) only written information on patient-centred communication or (b) written information plus CST for physicians or (c) written information plus interprofessional CST for physicians and nurses. For summative evaluation, standardised surveys from three measurement points for patients (T0pat: study enrollment; T1pat: after discharge; T2pat: 3 months' follow-up) and two measurement points for physicians and nurses (T0hcp: before the intervention; T1hcp: after the intervention) are used. N=1320 valid patient cases are needed for data evaluation. The primary endpoint is fear of progression in patients with cancer after discharge. Data will be analysed according to the intention-to-treat principle using a mixed model for repeated measurement. Secondary outcome is the providers' self-efficacy in patient centeredness. Individual confounders and possible moderating effects of organisational factors will be considered. Secondary analysis will be performed by means of multilevel analysis and structural equation modelling. ETHICS AND DISSEMINATION: A vote of approval has been obtained from the ethics committees of the medical faculties of RWTH Aachen University (EK325/20), University of Bonn (391/20), University of Cologne (20-1332) and Heinrich Heine University Düsseldorf (2019-796). Data protection regulations are adhered to for all processed data. The conduct of the study will be monitored. Dissemination strategies include a transfer workshop with cancer teams and distribution of the final study report to participants. TRIAL REGISTRATION NUMBER: DRKS00022563; DRKS (German Clinical Trials Register).

Dual guidance structure for evaluation of patients with unclear diagnosis in centers for rare diseases (ZSE-DUO): study protocol for a controlled multi-center cohort study.

BACKGROUND: In individuals suffering from a rare disease the diagnostic process and the confirmation of a final diagnosis often extends over many years. Factors contributing to delayed diagnosis include health care professionals' limited knowledge of rare diseases and frequent (co-)occurrence of mental disorders that may complicate and delay the diagnostic process. The ZSE-DUO study aims to assess the benefits of a combination of a physician focusing on somatic aspects with a mental health expert working side by side as a tandem in the diagnostic process. STUDY DESIGN: This multi-center, prospective controlled study has a two-phase cohort design. METHODS: Two cohorts of 682 patients each are sequentially recruited from 11 university-based German Centers for Rare Diseases (CRD): the standard care cohort (control, somatic expertise only) and the innovative care cohort (experimental, combined somatic and mental health expertise). Individuals aged 12 years and older presenting with symptoms and signs which are not explained by current diagnoses will be included. Data will be collected prior to the first visit to the CRD's outpatient clinic (T0), at the first visit (T1) and 12 months thereafter (T2). OUTCOMES: Primary outcome is the percentage of patients with one or more confirmed diagnoses covering the symptomatic spectrum presented. Sample size is calculated to detect a 10 percent increase from 30% in standard care to 40% in the innovative dual expert cohort. Secondary outcomes are (a) time to diagnosis/diagnoses explaining the symptomatology; (b) proportion of patients successfully referred from CRD to standard care; (c) costs of diagnosis including incremental cost effectiveness ratios; (d) predictive value of screening instruments administered at T0 to identify patients with mental disorders; (e) patients' quality of life and evaluation of care; and f) physicians' satisfaction with the innovative care approach. CONCLUSIONS: This is the first multi-center study to investigate the effects of a mental health specialist working in tandem with a somatic expert physician in CRDs. If this innovative approach proves successful, it will be made available on a larger scale nationally and promoted internationally. In the best case, ZSE-DUO can significantly shorten the time to diagnosis for a suspected rare disease. Trial registration ClinicalTrials.gov; Identifier: NCT03563677; First posted: June 20, 2018, https://clinicaltrials.gov/ct2/show/NCT03563677 .

Participative development and evaluation of a communication skills-training program for oncologists-patient perspectives on training content and teaching methods.

BACKGROUND: Using the 6-step approach to curriculum development for medical education, we developed a communication skills training (CST) curriculum for oncology and evaluated this curriculum from the perspective of cancer patients. METHODS: We conducted a qualitative interview study with cancer patients, collecting data using semi-structured face-to-face or telephone interviews with a short standardized survey. We fully transcribed the audiotaped interviews and conducted the content analysis using MAXQDA 2020. We analyzed the quantitative sociodemographic data descriptively. RESULTS: A total of 22 cancer patients participated, having a mean age of 60.6 (SD, 13.2) years and being predominantly female (55%). The patients believed that the CST curriculum addressed important aspects of patient-centered communication in cancer care. They emphasized the importance of physicians acquiring communication skills to establish a trusting relationship between doctor and patient, show empathy, inform patients, and involve them in treatment decisions. The patients had some doubts concerning the usefulness of strict protocols or checklists (e.g., they feared that protocol adherence might disturb the conversation flow). DISCUSSION: Although it was a challenge for some participants to take the perspective of a trainer and comment on the CST content and teaching methods, the patients provided a valuable perspective that can help overcome blind spots in CST concepts.

Comprehensive support for families with parental cancer (Family-SCOUT), evaluation of a complex intervention: study protocol for a non-randomized controlled trial.

BACKGROUND: Families with minor children affected by parental cancer are at risk of considerable emotional and organizational stress that can severely burden all family members. So far, there has been a lack of comprehensive support services for affected families. The aim of this project is to implement and evaluate a complex psychosocial intervention for these families by providing advice, information, and care on an emotional, psycho-social, and communicative level during and after the cancer experience and across healthcare sectors. METHODS: Family-SCOUT is a project supported by the German Innovation Fund ( https://innovationsfonds.g-ba.de/ ). The evaluation is based on a mixed-methods quasi-experimental design with the intervention and control groups. A standardized postal survey at three measurement points (T0: study enrollment; T1: 3 months of follow-up; T2: 9 months of follow-up), secondary data from the participating health insurance funds, and semi-structured qualitative interviews are used for summative and formative evaluation. The study aim is to include n=560 families. Data will be analyzed according to the intention-to-treat principle. The primary analysis is the comparison of the Hospital Anxiety and Depression Scale (HADS) response rates (minimal important difference (MID) ≥ 1.6 in at least one of the two parents) at T2 between the intervention and control group using Fisher's exact test. The conduct of the study as well as the development and implementation of the intervention will be accompanied by comprehensive study monitoring following the principles of an effectiveness-implementation hybrid study. DISCUSSION: The results will allow to test the effectiveness and efficiency of the intervention for the target group. The first experience with the implementation of the intervention in model regions will be available. The evaluation results will serve as the basis to assess the need of including the intervention in the catalog of services of the statutory health insurance funds in Germany. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04186923. Retrospectively registered on 4 December 2019.

[Psycho-oncological care in private practices: a survey among psychotherapists with and without licence for reimbursement with public health insurance]. / Psychoonkologische Versorgung bei niedergelassenen Psychotherapeuten: eine Befragung von Therapeuten mit und ohne Kassensitz.

Psycho-oncological care in private practices: a survey among psychotherapists with and without licence for reimbursement with public health insurance Objective: This study examined how certified psychotherapist working in an outpatient setting organise their practice to be able to treat cancer patients and what specific problems they encounter. We differentiated between therapists with and without licence. Methods: Out of the list of psychotherapists held by the German Cancer Information Service, a random sample of practices was selected. They received a mailed questionnaire. Per practice, only one therapist was selected. The questionnaire was developed by a group of psychotherapists from two psycho-oncological associations in Germany. Practices with and without licence were compared using chi-square, ranksum tests and multivariate regression analyses (adjusting for professional qualification and school of therapy). Results: Of 257 contacted practices, 160 therapists participated, and 144 were certified and could be included (62 without and 82 with licence). Waiting times for a first consultation for cancer patients were on average 10 days in practices of therapists without licence and 18 days with licence (p < 0.01). Crisis intervention within 3 days was possible for 62 % of the therapists without and for 44 % with licence (p = 0.08). There was no evidence for differences in what treatment options both types of therapists offered. Both groups reported that more than half of the cancer patients (60 % without and 58 % with licence) had to cancel their appointments at least once every 3 months, and 64 % of the therapists did not ask a fee for that. Financing of the treatment happened most frequently via compensation from health insurance companies via their licence in therapists with licence and via private payment or so called "Kostenerstattung" in therapists without licence. Discussion: In psycho-oncological practices, waiting times for a first consultation for cancer patients are on average 4 weeks shorter than in general, especially short in practices without licence. Cancellation of appointments by patients are relatively frequent in both groups of therapists, which bears financial risks for them. Special methods of compensation for services such as selective contracts are infrequently used..

Outcome comparison of integrated psycho-oncological care versus unstructured care-Results of a non-randomised open-label two-arm trial.

OBJECTIVE: To compare patients' experiences with a systematic, integrated psycho-oncological care (IC) model to experiences with "care as usual" (CAU). METHODS: To improve patients' knowledge about psychosocial support options and to facilitate use, an IC model was developed by psycho-oncologists and a health insurance company and implemented in one German cancer care facility. Using a parallel, non-randomised design, these patients' experiences were compared to CAU patients. In 2015, both patient groups received questionnaires 6-12 months post-inpatient treatment. Main outcomes were awareness, use and opinion of psycho-oncological care (PC) and anxiety level (Generalized Anxiety Disorder Scale (GAD-7)). RESULTS: 228 patients (IC = 90; CAU = 138) participated (response rate 24%). More IC patients felt adequately informed about PC (63% vs. 46%, ORadj : 2.5 (CI: 1.3-4.8); p = 0.008). More IC patients recalled being offered various support options and had had at least one PC discussion (44% vs. 33%, ORadj of IC patient saying "yes" instead of "No, didn't want to" compared to a CAU patient: 0.4 (CI: 0.2-0.8); p = 0.01). More IC patients rated their care as good/excellent (49% vs. 38%, ORadj : 1.8 (CI: 0.7-4.1; p = 0.2)). Anxiety levels were similar (GAD-7 score>=10: IC 34% vs. CAU 28%; p = 0.4). CONCLUSION: Structured psycho-oncological care had some positive results on the outcomes, but anxiety levels did not differ.

Design and development of a disease-specific quality of life tool for patients with aplastic anaemia and/or paroxysmal nocturnal haemoglobinuria (QLQ-AA/PNH)-a report on phase III.

To date, instruments to measure quality of life (QoL) specifically for patients with acquired aplastic anaemia (AA) and paroxysmal nocturnal haemoglobinuria (PNH) are lacking altogether. As a consequence, this issue is either underevaluated or alternatively, instruments originally designed for cancer patients are being used. We therefore started to systematically develop a AA/PNH-specific QoL (QLQ-AA/PNH) instrument in these ultra-rare diseases according to European Organisation for Research and Treatment of Cancer (EORTC) guidelines. While phases I and II of the process have previously been published, we now report on the resulting instrument (phase III of this process). As part of the phase III of the evaluation process, we approached patients through physicians, patient support groups, and patient conferences. After participants completed the preliminary questionnaire and reported socio-demographic data, they were interviewed in person or via phone with a debriefing interview to find out whether the items were relevant, easy to understand, and acceptable to patients and whether there was anything missing in the questionnaire. We hypothesised what items could be combined into a scale and calculated Cronbach's alpha to define its preliminary internal consistency. After definition of a priori criteria to keep or delete items, a group of six experts met in person, discussed the results, and decided on in- or exclusion. A total of 48 patients were enrolled, 21 of those suffered from AA (44%), 13 from PNH (27%), and 14 from AA/PNH syndrome (29%). The median time to complete the 69 items was 10 min (range 5-20), mean time 11 min. The compliance criterion (> 95% completion) was fulfilled by 57 items. Twenty-three items were mentioned as especially relevant by ≥ 2% of the patients. Cronbach's alpha of the hypothesised scales ranged from 0.63 (social support) to 0.92 (fear of progression and illness intrusiveness). Finally, 47 items were kept; 16 were deleted, and 5 were changed, while 1 item expanded. This resulted in 54 items in total. As no issues were mentioned to lacking by a minimum of five patients, no items were added to the questionnaire. After completion, the AA/PNH-QoL tool (QLQ-AA/PNH) was translated according to EORTC guidelines into English, French, and Italian. For patients with PNH and AA until now, the standard assessment for QoL was to use the EORTC Quality of Life Questionnaire (QLQ-C30) or the Functional Assessment of Chronic Illness Therapy Fatigue Instrument (FACIT-Fatigue). We herewith present a new instrument aimed to be better tailored to the needs of PNH and AA patients. The anticipated fourth development phase will be performed for psychometric validation; however, we already explored the internal consistency of the hypothesised scales and found the results to be very good. Hence, the new QLQ-AA/PNH with 54 items can be used in trials and clinical studies from now on, according to EORTC strategy even if the scoring algorithm at this point is preliminary and the QLQ-AA/PNH might change slightly after phase IV. This is important, as there are no other disease-specific instruments available for AA/PNH patients right now.

Distress thermometer for preoperative screening of patients with oral squamous cell carcinoma.

In this study, we evaluate the association between distress, various demographic and medical variables, and the prevalence of psychosocial distress in preoperative patients with oral squamous cell carcinoma. A total of 100 consecutive patients were recruited into the study and asked to complete the Distress Thermometer (DT) form with the Problem List questionnaire prior to surgical intervention; the average distress score was 5.7 ± 2.7. The distress score was neither correlated with age (r = -0.025; p = 0.804) nor with tumor size (r = 0.028; p = 0.785). General worries, anxiety, sadness, depression, pain, exhaustion, sleeping disorders, or problems with nutrition resulted in significantly higher distress scores compared to patients without these complaints. Individuals with a DT score of 5 or higher (p = 0.006) were advised to seek out psychological support. There is a strong correlation between a high DT score and emotional disorders, as well as physical problems.

Communication Skills Trainings: Subjective Appraisal of Physicians from Five Cancer Centres in North Rhine, Germany.

BACKGROUND: Physician-patient communication is an essential component of high-quality health care provision for cancer patients. To date, communication skills training programmes have not been systematically implemented in oncology and have low physician participation rates. METHODS: As a part of a needs assessment a written questionnaire was used to explore needs and preferences (structural conditions and content) regarding communication skills training programmes for physicians working in oncology settings in 5 university hospitals in North Rhine, Germany. RESULTS: 207 physicians took part in the survey. Analyses revealed positive attitudes and high willingness to attend such training programmes, with a preference for short trainings that are compatible with clinical practice. Suggested topics included breaking bad news, conversations about death and dying and dealing with difficult emotions. CONCLUSION: Communication skills training approaches should not only pay attention to evidence regarding their efficacy, but also take into consideration physicians' needs and preferences. Further research is required on the subject of barriers to participation in such training programmes.

Development of a disease-specific quality of life questionnaire for patients with aplastic anemia and/or paroxysmal nocturnal hemoglobinuria (QLQ-AA/PNH)-report on phases I and II.

Acquired aplastic anemia (AA) and paroxysmal nocturnal hemoglobinuria (PNH) are interrelated ultra-rare diseases. Quality of life (QoL) evaluation tools used in studies for AA and PNH are unspecific and designed for cancer patients (e.g., the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, EORTC QLQ-C30). Given the complexity of AA and PNH, variation in symptoms and treatments, younger age of many patients, and the fact that AA and PNH are not classified as malignant diseases, it is likely that cancer-specific questionnaires are inappropriate. We generate an AA/PNH-specific QoL questionnaire (QLQ-AA/PNH), performed according to EORTC guidelines. QoL issues were obtained from the literature and interviews with patients and physicians (phase I), then ranked by patients and physicians. In phase II, items were created. Patients in more than 25 German and Swiss cities were interviewed face to face. In phase I, interviews of 19 patients and 8 physicians specialized in AA/PNH treatment resulted in 649 QoL issues; these were condensed to 175 and graded according to their importance by 30 patients and 14 physicians (phase II). Five physicians took part in phases I and II. Altogether, 97 issues were rated important. Twelve EORTC QLQ-C30 items were not rated important, while several new QoL aspects were brought up. Modifications in wording and phrasing led to two questionnaires with 77 items regarding general QoL aspects and 20 items regarding medical care. Important QoL aspects of PNH/AA patients are inappropriately captured with available QoL tools. Developing a new QoL questionnaire specific for this patient group is warranted.

[KoMPASS--design, implementation and experiences concerning a structured communication skills training for physicians dealing with oncology]. / KoMPASS - Konzeption, Implementierung und Erfahrungen mit einem strukturierten Kommunikationstraining für onkologisch tätige Ärzte.

Goal of the KoMPASS project is to develop and test a training program that effectively improves oncologists' communication skills. The training draws with regard to concept, content and didactic methods to the specific challenges arising in interactions with cancer patients. Concept and didactical methods for an intensive training (KoMPASS Training) are being presented and complemented with experiences gathered during 39 trainings with 335 physicians, as well as findings from the training evaluation by participants. The participants' feedback after 4 months indicates successful transfer into clinical practice along with personal relief, improved self-efficacy, and communicative competencies. Even experienced practitioners ascribe high practical usefulness, and personal learning achievements to the KoMPASS training. The results of the concomitant study concerning self-efficacy, empathy, work-related stress and communicative competence will be published later.