HELP - Heidelberg decision aid for lung cancer patients: a randomized controlled clinical trial.

BACKGROUND: Shared decision-making (SDM), which increases the patient's well-being, adherence, and success of treatment, is becoming increasingly important in medicine and especially in oncology. To empower patients to participate more actively in consultations with their physicians decision aids have been developed. In non-curative settings, such as the treatment of advanced lung cancer, decisions differ substantially from the curative setting, as uncertain gains in terms of survival outcomes and quality of life have to be weighed against the severe side effects of treatment regimens. There is still a lack of tools developed and implemented for such specific settings in cancer therapy that support shared decision-making. The aim of our study is to evaluate the effectiveness of the HELP decision aid. METHODS: The HELP-study is designed as a randomized, controlled, open monocenter trial with two parallel groups. The intervention consists of the use of the HELP decision aid brochure, accompanied by a decision coaching session. The primary endpoint is clarity of personal attitude as operationalized by the Decisional Conflict Scale (DCS) after the decision coaching. Randomization will be performed as stratified block randomization according to the characteristic of preferred decision-making at baseline with a 1:1 allocation. The participants in the control group get usual care, i.e., the doctor-patient conversation takes place without preliminary coaching and deliberation about their preferences and goals. DISCUSSION: Developing decision aids (DA) for (lung) cancer patients with limited prognosis should empower patients to address these aspects and include information about "Best Supportive Care" as a treatment option. Using and implementing the decision aid HELP can not only give patients the possibility to include their personal wishes and values in the decision-making process, but also raise the awareness of shared decision-making itself among these patients and their physicians. TRIAL REGISTRATION: German Clinical Trial Register DRKS00028023. Registered on 8 February 2022.

Communication with patients with limited prognosis-an integrative mixed-methods evaluation study.

PURPOSE: Oncological societies advocate the continuity of care, specialized communication, and early integration of palliative care. To comply with these recommendations, an interprofessional, longitudinally-structured communication concept, the Milestone Communication Approach (MCA), was previously developed, implemented, and evaluated. Our research question is: what are possible explanations from the patient perspective for prognosis and advance care planning being rarely a topic and for finding no differences between MCA and control groups concerning distress, quality of life, and mood? METHODS: A pragmatic epistemological stance guided the study. A mixed-methods design was chosen including a pragmatic randomized trial (n = 171), qualitative interviews with patients (n = 13) and caregivers (n = 12), and a content analysis (133 milestone conversations, 54 follow-up calls). Data analysis involved the pillar integration process. RESULTS: Two pillar themes emerged: 1 "approaching prognosis and advance care planning"; 2 "living with a life-threatening illness". Information on prognosis seemed to be offered, but patients' reactions were diverse. Some patients have to deal with having advanced lung cancer while nonetheless feeling healthy and seem not to be ready for prognostic information. All patients seemed to struggle to preserve their quality of life and keep distress under control. CONCLUSION: Attending to patients' questions, worries and needs early in a disease trajectory seems key to helping patients adjust to living with lung cancer. If necessary clinicians should name their predicament: having to inform about prognosis versus respecting the patients wish to avoid it. Research should support better understanding of patients not wishing for prognostic information to successfully improve communication strategies. TRIAL REGISTRATION: Registration: German Clinical Trial Register No. DRKS00013649, registration date 12/22/2017, ( https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00013649 ) and No. DRKS00013469, registration date 12/22/2017, ( https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00013469 ).

Factors related to implementation of an interprofessional communication concept in thoracic oncology: a mixed-methods study.

BACKGROUND: An innovative patient-centred interprofessional communication concept with advanced lung cancer patients (Heidelberg Milestone Communication Approach, MCA) has been developed and implemented. Role changes and interprofessional communication are challenging in a busy outpatient oncology service. The aim of the study was to present attitudes to interprofessional collaboration of professions in thoracic oncology during the implementation of MCA and to explore factors and experiences healthcare team members associate with its implementation. METHODS: In a longitudinal study, 3 of the 4 subscales of the validated German translation of the University of the West of England Interprofessional Questionnaire (UWE-IP-D) were collected prior to implementation of MCA (t0) with follow-up data collections at 4 months (t1), 10 months (t2) and 17 months (t3). Descriptive analysis included calculating subscale sum scores and categorizing each subscale into positive, neutral and negative attitudes. Interviews and focus groups on implementation and interprofessional collaboration in the context of MCA were conducted with healthcare staff. The topics were analysed deductively, guided by the Professional Interactions factor of the Tailored Implementation for Chronic Diseases (TICD) framework. RESULTS: The survey with 87 staff (44 nurses, 13 physicians, 12 psycho-social staff, 7 therapists, and 11 others) participating at least once found heterogeneous attitudes. 'Communication and Teamwork' and 'Interprofessional Relationships' were characterized by primarily positive attitudes. Neutral attitudes to 'Interprofessional Interaction' were indicated by the majority of respondents. There were no differences between collection times. Fifteen staff members participated in the interviews and focus groups. The main interprofessional interaction factors associated with implementation concerned the knowledge of the MCA and the impact of the intervention on team roles, on information sharing and on transfer processes between wards. Adaptive processes led to a shift in the perception of responsibilities and interprofessional collaboration. CONCLUSIONS: Positive experiences and potential shortfalls in the implementation were observed. Future introductions of interprofessional communication concepts require further activities which should address the attitudes of healthcare professionals towards interprofessional care. TRIAL REGISTRATION: DRKS00013469 / Date of registration: 22/12/2017.

Developing a question prompt list for the oncology setting: A scoping review.

OBJECTIVE: The purpose of this study was to provide an overview of existing methods used to develop a Question Prompt List (QPL) for an oncology setting. METHODS: We conducted a search of the literature published between 1999 and 2019 in five online databases followed by a hand search, and extracted data on the methods used to develop a QPL. RESULTS: A total of 21 studies were included. The review shows differences in the development of older QPLs (1999-2009) and current QPLs (2010-2019). However, most QPLs were developed using interviews or focus groups with patients and an expert session to review or adapt the QPL. Health professionals, patients, and researchers were included in nearly all the studies. CONCLUSION: To develop a QPL, it is important to combine several information sources and at least to involve health professionals, patients, and researchers in the development process. Review or evaluation steps can improve the appropriateness and acceptance of a QPL. PRACTICE IMPLICATIONS: Further research is needed to define the type of target population for new QPLs and to develop a framework for their development.

[Heidelberg Milestones Communication (HeiMeKOM) - Experiences, Best Practice Examples and Recommendations from the Final Symposium on January 30 and 31 in 2020]. / Heidelberger Meilenstein Kommunikation (HeiMeKOM) ­ Erfahrungen, Best Practice Beispiele und Empfehlungen aus dem Abschluss-Symposium am 30./31. Januar 2020.

The National Cancer Plan emphasises the importance of medical communication and calls for its integration into medical education and training. In this context, the Milestone Communication Approach meets the communicative challenges in dealing with lung cancer patients. Interprofessional tandems, consisting of doctors and nurses, conduct structured conversations at defined moments with patients and their relatives. The concept aims at shared decision making, continuity in the care of lung cancer patients and the early integration of palliative care. During the symposium on the Heidelberg Milestone Communication in January 2020, recommendations on the care situation of lung cancer patients in advanced stages were developed. In addition, the further adaptability of HeiMeKOM to other settings and hospitals and to other diseases was discussed as well as the possibility of implementing such a concept in standard care. This article presents the experiences, best practice examples and recommendations discussed during the symposium in order to enable their extrapolation to other similarly oriented projects. The long-term goal is to transfer the milestone concept to other hospital, primarily certified lung cancer centers, and to ensure permanent funding. For further dissemination of the concept and, above all, to have it established in standard care, health policy awareness and support are required in addition to the integration of the concept in competence catalogues of continuing medical and nursing education.

Effects of an Interprofessional Communication Approach on Support Needs, Quality of Life, and Mood of Patients with Advanced Lung Cancer: A Randomized Trial.

BACKGROUND: To address the support needs of newly diagnosed patients with lung cancer with limited prognosis, the Milestone Communication Approach (MCA) was developed and implemented. The main elements of the MCA are situation-specific conversations along the disease trajectory conducted by an interprofessional tandem of physician and nurse. The aim of the study was to evaluate the effects of MCA on addressing support needs, quality of life, and mood as compared with standard oncological care. PATIENTS AND METHODS: A randomized trial was conducted with baseline assessment and follow-up assessments at 3, 6, and 9 months in outpatients with newly diagnosed lung cancer stage IV at a German thoracic oncology hospital. The primary outcome was the Health System and Information Needs subscale of the Short Form Supportive Care Needs Survey (SCNS-SF34-G) at 3-month follow-up. Secondary outcomes included the other subscales of the SCNS-SF34-G, the Schedule for the Evaluation of Individual Quality of Life, the Functional Assessment of Cancer Therapy lung module, the Patient Health Questionnaire for Depression and Anxiety, and the Distress Thermometer. RESULTS: At baseline, 174 patients were randomized, of whom 102 patients (MCA: n = 52; standard care: n = 50) provided data at 3-month follow-up. Patients of the MCA group reported lower information needs at 3-month follow-up (mean ± SD, 33.4 ± 27.5; standard care, 43.1 ± 29.9; p = .033). No effects were found for secondary outcomes. CONCLUSION: MCA lowered patient-reported information needs but did not have other effects. MCA contributed to tailored communication because an adequate level of information and orientation set the basis for patient-centered care. IMPLICATIONS FOR PRACTICE: By addressing relevant issues at predefined times, the Milestone Communication Approach provides individual patient-centered care facilitating the timely integration of palliative care for patients with a limited prognosis. The needs of patients with lung cancer must be assessed and addressed throughout the disease trajectory. Although specific topics may be relevant for all patients, such as information about the disease and associated health care, situations of individual patients and their families must be considered. Additionally, using the short form of the Supportive Care Needs Survey in clinical practice to identify patients' problems might support individually targeted communication and preference-sensitive care.

Lung cancer patients' comorbidities and attendance of German ambulatory physicians in a 5-year cross-sectional study.

The majority of lung cancer patients are diagnosed with an advanced stage IV, which has short survival time. Many lung cancer patients have comorbidities, which influence treatment and patients' quality of life. The aim of the study is to describe comorbidities in incident lung cancer patients and explore their attendance of ambulatory care physicians in Germany. In the observed period, 13,111 persons were first diagnosed with lung cancer (1-year incidence of 36.4 per 100,000). The mean number of comorbidities over 4 quarters was 30.77 ± 13.18; mean Charlson Comorbidity Index was 6.66 ± 2.24. In Germany, ambulatory care physicians most attended were general practitioners (2.6 quarters with contact within 4 quarters). Lung cancer was diagnosed by a general practitioner in 38% of the 13,111 incident patients. The average number of ambulatory care physician contacts over 4 quarters was 35.82 ± 27.31. High numbers of comorbidities and contacts in ambulatory care are common in patients with lung cancer. Therefore, a cross-sectoral and interdisciplinary approach is required for effective, patient-centred care. This was a 5-year cross-sectoral study, based on the InGef research database, which covers anonymized health insurance data of 7.2 million individuals in Germany. Incident lung cancer patients in a 5-year period (2013-2017) were identified. Descriptive statistics were calculated for sociodemographic characteristics, comorbidities, and attendance of ambulatory care physicians.

Consideration of sense of coherence in a structured communication approach with stage IV lung cancer patients and their informal caregivers: a qualitative interview study.

OBJECTIVE: Salutogenetic aspects are valuable for consideration in patient-centred care of advanced oncological diseases with a limited life expectancy. The Milestone Communication Approach (MCA), involving physician-nurse tandems, addresses specific challenges and needs over the disease trajectory of patients with stage IV lung cancer and their informal caregivers. This study aims to explore patients' and informal caregivers' salutogenetic experiences with the MCA concept. METHODS: This qualitative study used face-to-face semi-structured interviews with patients and informal caregivers. All generated data were audio-recorded, pseudonymised and transcribed verbatim. Data were structured using Qualitative Content Analysis. The material was coded deductively into themes related to the components of sense of coherence (Aaron Antonovsky) and emerging sub-themes. All data was managed and organised in MAXQDA. RESULTS: In 25 interviews, sense of coherence was referred to with all three components: "Comprehensibility" was supported by information conveyed suitably for the patients; "meaningfulness" was addressed as accepting the situation; and "manageability" led to advance care planning the patients were comfortable with. Patients and informal caregivers experienced the interprofessional tandem as an added value for patient care. CONCLUSIONS: Participants appreciate the MCA in its support for coping with a life-limiting disease. Considering salutogenetic aspects facilitates prognostic awareness and advance care planning. Nevertheless, individual needs of patients and informal caregivers require an individualised application of the MCA.

What patients with lung cancer with comorbidity tell us about interprofessional collaborative care across healthcare sectors: qualitative interview study.

BACKGROUND: Patients with lung cancer with comorbidity often require treatment and care by different health professionals, in different settings and at different points in time during the course of the disease. In order to organise and coordinate healthcare efficiently, effective information exchange and collaboration between all involved care providers are required. The aim of this study was to assess the views of patients with advanced lung cancer with comorbidity regarding coordination of treatment and care across healthcare sectors. METHODS: This qualitative study, as part of the main study, The Heidelberg Milestones Communication Approach, used face-to-face guide-based semistructured interviews with patients with advanced lung cancer and their informal caregivers to explore cross-sectoral information exchange and collaboration in Germany. All generated data were audio-recorded, pseudonymised and transcribed verbatim. Data analysis was performed using qualitative content analysis to structure data into themes and subthemes. All data were managed and organised in MAXQDA. RESULTS: In 15 interviews, participants reported that cross-sectoral collaboration functioned well, if treatments occurred as planned. However, treatment gaps were experienced, especially regarding medication and regimen. As a result, participants felt insecure and obliged to take responsibility for the coordination of healthcare. Patients reported to be in favour of an active patient role but felt that healthcare coordination should still be a responsibility of a care provider. A more intensive information exchange, potentially by using an electronic platform, was expected to strengthen cross-sectoral collaboration. CONCLUSION: Patients with lung cancer are uncertain about their role in the coordination of treatment and care across healthcare sectors. Healthcare providers should be more aware of care recipients' willingness of taking on a more active role in healthcare coordination. TRIAL REGISTRATION NUMBER: DRKS00013469.

Patient expectations are better for immunotherapy than traditional chemotherapy for cancer.

PURPOSE: The main aim of the study was to explore the expectations and knowledge of advanced-stage cancer patients about immunotherapy. METHODS: This mixed methods study included 53 cancer patients on immune checkpoint inhibitors (ICIs), 55 cancer patients undergoing chemotherapy (CT), and 53 non-cancer patients. Participants' expectations about ICIs and CT were compared. Additional qualitative data were derived from semi-structured interviews. RESULTS: Among patients who did not receive ICIs, 63 (58%) had never heard of ICIs and 94 (87%) had large gaps in their knowledge of ICIs. Among ICI patients, 33 (62%) simply described ICIs without errors. ICI perception was positive, regardless of whether respondents received or had heard of ICIs, which became particularly evident when compared to CT. ICIs were rated as more promising, and all adverse effects were expected to be significantly lower than those of CT. Knowledge about ICIs was also limited in the interviewed ICI patients. Some patients reported adverse effects of ICIs that were mostly mild and well-tolerated or easily treated. CONCLUSIONS: The lack of understanding of ICIs should be improved by activities to increase the knowledge of ICI patients and the general population. In contrast to CT, ICIs invoked fewer negative associations with efficacy and toxicity. Therefore, attention should be paid to risk awareness when educating patients. (Clinical trial registration number: DRKS00011868) Trial Registration: German clinical trials register, www.germanctr.de , number DRKS00011868.

Implementation of the milestones communication approach for patients with limited prognosis: evaluation of intervention fidelity.

BACKGROUND: Despite improvements in diagnostics and therapy, the majority of lung tumours are diagnosed at advanced stage IV with a poor prognosis. Due to the nature of an incurable disease, patients need to engage in shared decision making on advance care planning. To implement this in clinical practice, effective communication between patients, caregivers and healthcare professionals is essential. The Heidelberg Milestones Communication Approach (MCA) is delivered by a specifically trained interprofessional tandem and consists of four milestone conversations (MCs) at pivotal times in the disease trajectory. MC 1 (Diagnosis): i.e. prognosis; MC 2 (Stable disease): i.e. prognostic awareness; MC 3 (Progression): i.e. reassessment; MC 4 (Best supportive care): i.e. end of treatment. In between MCs, follow-up calls are carried out to sustain communication. This study aimed to assess to what extent the MCA was implemented as planned and consolidated in specialized oncology practice. METHODS: A prospective observational process evaluation study was conducted, which focused on the implementation fidelity of the MCA. All MCs during two assessment periods were included. We analysed all written records of the conversations, which are part of the routine documentation during MCs and follow-up calls. Adherence to key aspects of the manual was documented on structured checklists at the beginning of the implementation of the MCA and after 6 months. The analysis was descriptive. Differences between the two assessment periods are analysed with chi-square tests. RESULTS: A total of 133 MCs and 54 follow-up-calls (t1) and of 172 MCs and 92 follow-up calls (t2) were analysed. MC 2 were the most frequently completed conversations (n = 51 and n = 47). Advance care planning was discussed in 26 and 13% of MC 2 in the respective assessment periods; in 31 and 47% of MC 2, prognostic awareness was recorded. The most frequently documented topic in the follow-up calls was the physical condition in patients (82 and 83%). CONCLUSION: The implementation of a trajectory-specific communication concept was largely successful. Additional studies are needed to understand how fidelity could be further improved. TRIAL REGISTRATION: DRKS00013469 / Date of registration: 22.12.2017.

Cancer Patients' Preferences for either Quality of Life or a Longer Life Determine Their Willingness to Talk about Forgoing Cancer-Specific Treatment.

BACKGROUND: Cancer patients often face decisions whether to proceed with cancer-specific treatment or to switch to best supportive care. In these decisions, patients' preferences should be determining cornerstones. The aim of this survey was to elicit patients' preferences regarding discussions about forgoing treatment and factors influencing their preferences. METHODS: We surveyed 194 patients at the National Center for Tumor Diseases, Germany. Quality of life (FACT-G), cancer-specific distress (QSC-R10), anxiety/depression (PHQ-4/GAD-2), preferences regarding quality/length of life (QQ), patient-physician communication (CARES-SF), and family role (CCAT-P) were assessed. RESULTS: Patients weighting quality of life over lifetime wanted their oncologists to address treatment limitations as early as possible (p = 0.00). Patients striving for a longer lifetime did not want such discussions (p = 0.05). Having discussed treatment limitations was not associated with increased anxiety, depression, or distress. Limiting treatment was discussed only with one-third of the patients with a prognosis of less than 6 months and rather with elderly patients or patients in a worse medical condition. Attributing an important role to family decisions was associated with striving for lifetime (p = 0.01). CONCLUSION: Preferences for either quality or length of life were associated with patients' willingness to discuss forgoing cancer-specific treatment. Timely discussion of realistic treatment goals is one way to avoid overtreatment. Patients striving for lifetime require increased attention and opportunities to address prognosis and risks of treatment.

[HeiMeKOM (Heidelberg Milestones Communication): development of an interprofessional intervention for improvement of communication in patients with limited prognosis]. / HeiMeKOM (Heidelberger Meilenstein Kommunikation): Entwicklung einer interprofessionellen Intervention zur Verbesserung der Kommunikation bei Patient*innen mit eingeschränkter Prognose.

BACKGROUND: The care for patients with advanced disease and limited prognosis and their relatives is complex and characterized by insufficient communication and lack of coordination and continuity. AIM: Development of an interprofessional, practice-guided concept of longitudinally structured communication with the goal of fostering communication, improving quality of life and facilitating early integration of palliative care. METHODS: Multi-level process starting from a draft with discussion and approval within the multiprofessional team and correlation with interviews with patients and relatives. Preparation of a comprehensive concept with review of the literature, problem analysis, theoretical foundation, goal setting and intervention components. Discussion of suitability for daily use, adaptation and further development of the concept. RESULTS AND CONCLUSIONS: Concept with the following components: interprofessional communication training, structured conversations at defined moments in a tandem of physician and nurse with patient and relative, follow-up conversations conducted by the nurse, and respective instruments (conversation protocol, question prompt list, memory cards). Only iterative discussion with and the approval of patients, relatives and the multiprofessional team and their approval will put the concept into practice.

Impact of EMT in stage IIIB/IV NSCLC treated with erlotinib and bevacizumab when compared with cisplatin, gemcitabine and bevacizumab.

The aim of the present study was to assess the expression of epithelial-mesenchymal transition biomarkers (E-cadherin and vimentin) and their potential significance as prognostic markers in patients with stage IIIB/IV non-squamous non-small cell lung cancer (NSCLC) enrolled in the INNOVATIONS trial, receiving treatment with either erlotinib/bevacizumab (EB) or cisplatin/gemcitabine/bevacizumab (PGB). The tumor tissues of 104 patients were retrospectively analyzed using immunohistochemistry to assess the expression of E-cadherin and vimentin. The distribution between the treatment arms was 46 patients in the EB-arm and 58 in the PGB-arm. Comparing the treatment arms according to E-cadherin and vimentin expression, the analysis revealed that progression-free survival (PFS) was increased in the PGB treatment group when compared with EB treatment in patients with low expression of E-cadherin [hazard ratio (HR)=0.353; 95% confidence interval (CI) 0.189- 0.658; log-rank P=0.0007] and in those with high expression of vimentin [HR=0.276 (95% CI, 0.115- 0.659), log-rank P=0.0021]. In patients that exhibited high E-cadherin and were negative for vimentin, there was no difference in the PFS between the PGB and EB treatment groups. In conclusion, in non-squamous NSCLC with downregulated E-cadherin and upregulated vimentin, the efficacy of chemotherapy with PGB was superior compared with EB; but the same effect was not observed in patients with high E-cadherin and low vimentin. Although increased PFS was observed in patients with PGB treatment compared with EB treatment in the whole analysis populations, in the subgroup of patients with the mesenchymal phenotype, no prognostic or predictive value of either biomarker could be identified. The potential role of bevacizumab in overcoming chemotherapy resistance in the population with the mesenchymal phenotype has to be further explored.

Communication along Milestones in Lung Cancer Patients with Advanced Disease.

Patients with advanced lung cancer and their caregivers are confronted with a complex situation as their disease-related burden comprises physical, psychosocial, and spiritual needs. During the illness trajectory with limited prognosis, they are exposed to different multidisciplinary healthcare settings and providers that challenge the continuity and coordination of care. Additionally, decision-making between active cancer treatment and end-of-life care constitutes a continuous balancing act. Several studies have shown that early integration of palliative care and adequate advance care planning improve quality of life and satisfaction with care. For this strategy, the communication skills of healthcare providers and interprofessional collaboration should be strengthened. A longitudinally structured communication approach along pivotal milestones of the disease can empower patients by facilitating coping and prognostic awareness, and achieve early integration of palliative care and advance care planning. Good interprofessional collaboration and communication lead to better coordination and continuity of care.

The Heidelberg Milestones Communication Approach (MCA) for patients with prognosis <12 months: protocol for a mixed-methods study including a randomized controlled trial.

BACKGROUND: The care needs of patients with a limited prognosis (<12 months median) are complex and dynamic. Patients and caregivers must cope with many challenges, including physical symptoms and disabilities, uncertainty. and compromised self-efficacy. Healthcare is often characterized by disruptions in the transition between healthcare providers. The Milestones Communication Approach (MCA) is a structured, proactive, interprofessional concept that involves physicians and nurses and is aimed at providing coherent care across the disease trajectory. This study aims to evaluate these aspects of MCA: (1) the training of healthcare professionals, (2) implementation context and outcomes, (3) patient outcomes, and (4) effects on interprofessional collaboration. METHODS/DESIGN: A multiphase mixed-methods design will be used for the study. A total of 100 patients and 120 healthcare professionals in a specialized oncology hospital will be involved. The training outcomes will be documented using a questionnaire. Implementation context and outcomes will be explored through semi-structured interviews and written questionnaires with healthcare professionals and with the training participants and through a content analysis of patient files. Patient outcomes will be assessed in a pragmatic non-blinded randomized controlled trial and in qualitative interviews with patients and caregivers. Trial outcomes are supportive care needs (SCNS-SF34-G), quality of life (SeiQol and Fact-L), depression and anxiety symptoms (PHQ-4), and distress (Distress Thermometer). Qualitative semi-structured interviews on patients' views will focus on shared decision-making, communication needs, feeling empathy, and further utilization of healthcare services. Interprofessional collaboration will be explored using the UWE-IP-D before the implementation of MCA (t0) and after 3 (t1), 9 (t2), and 12 (t3) months. DISCUSSION: Using guideline-concordant early palliative care, MCA aims to foster patient-centered communication with shared decision-making and facilitation of advance care planning including end-of-life decisions, thus increasing patient quality of life and decreasing aggressive medical care at the end of life. It is assumed that the communication skills training and interprofessional coaching will improve the communication behavior of healthcare providers and influence team communications and team processes. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00013649 and DRKS00013469. Registered on 22 December 2017.

ERCC1 assessment in upfront treatment with and without cisplatin-based chemotherapy in stage IIIB/IV non-squamous non-small cell lung cancer.

Prior studies have demonstrated an association between excision repair cross-complementation group 1 (ERCC1) expression level and outcomes in patients with advanced non-small cell lung cancer (NSCLC) treated with platinum-based chemotherapy. The aim of this study was to assess the impact of ERCC1 on survival for patients with stage IIIB/IV non-squamous NSCLC (NS-NSCLC) enrolled in the INNOVATIONS trial, thus receiving as treatment either erlotinib/bevacizumab (EB) or cisplatin/gemcitabine/bevacizumab (PGB). We retrospectively analyzed tumor tissue of 72 patients using immunohistochemistry to assess the expression of ERCC1. The distribution between treatment arms was equal (36 patients each). Two different H scores were calculated and correlated with survival. In ERCC1-positive patients, no significant difference in terms of progression-free survival (PFS) between treatment arms has been detected. ERCC1-negative patients benefited from PGB compared to EB arm (H score: HR = 0.377, 95% CI [0.167-0.849], p = 0.0151; modified H score: HR = 0.484, 95% CI [0.234-1.004], p = 0.0468). With respect to the scoring system, in the EB-arm, a significant superior PFS turned out in ERCC1-positive patients when employing the H-score (HR = 0.430, 95% CI [0.188-0.981], p = 0.0397; median 4.9 vs. 3.9 months), but not with the modified H-score. Our findings support the hypothesis that NS-NSCLC displaying a low ERCC1 expression might benefit from cisplatin-based chemotherapy. High expression indicated better PFS in the EB arm supporting the prognostic impact. However, as impact of ERCC1-assessment even might depend on scoring systems differences, the need in standardization of assessment methodology is emphasized.

Early palliative care for adults with advanced cancer.

BACKGROUND: Incurable cancer, which often constitutes an enormous challenge for patients, their families, and medical professionals, profoundly affects the patient's physical and psychosocial well-being. In standard cancer care, palliative measures generally are initiated when it is evident that disease-modifying treatments have been unsuccessful, no treatments can be offered, or death is anticipated. In contrast, early palliative care is initiated much earlier in the disease trajectory and closer to the diagnosis of incurable cancer. OBJECTIVES: To compare effects of early palliative care interventions versus treatment as usual/standard cancer care on health-related quality of life, depression, symptom intensity, and survival among adults with a diagnosis of advanced cancer. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, OpenGrey (a database for grey literature), and three clinical trial registers to October 2016. We checked reference lists, searched citations, and contacted study authors to identify additional studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) and cluster-randomised controlled trials (cRCTs) on professional palliative care services that provided or co-ordinated comprehensive care for adults at early advanced stages of cancer. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures as expected by Cochrane. We assessed risk of bias, extracted data, and collected information on adverse events. For quantitative synthesis, we combined respective results on our primary outcomes of health-related quality of life, survival (death hazard ratio), depression, and symptom intensity across studies in meta-analyses using an inverse variance random-effects model. We expressed pooled effects as standardised mean differences (SMDs, or Hedges' adjusted g). We assessed certainty of evidence at the outcome level using GRADE (Grading of Recommendations Assessment, Development, and Evaluation) and created a 'Summary of findings' table. MAIN RESULTS: We included seven randomised and cluster-randomised controlled trials that together recruited 1614 participants. Four studies evaluated interventions delivered by specialised palliative care teams, and the remaining studies assessed models of co-ordinated care. Overall, risk of bias at the study level was mostly low, apart from possible selection bias in three studies and attrition bias in one study, along with insufficient information on blinding of participants and outcome assessment in six studies.Compared with usual/standard cancer care alone, early palliative care significantly improved health-related quality of life at a small effect size (SMD 0.27, 95% confidence interval (CI) 0.15 to 0.38; participants analysed at post treatment = 1028; evidence of low certainty). As re-expressed in natural units (absolute change in Functional Assessment of Cancer Therapy-General (FACT-G) score), health-related quality of life scores increased on average by 4.59 (95% CI 2.55 to 6.46) points more among participants given early palliative care than among control participants. Data on survival, available from four studies enrolling a total of 800 participants, did not indicate differences in efficacy (death hazard ratio 0.85, 95% CI 0.56 to 1.28; evidence of very low certainty). Levels of depressive symptoms among those receiving early palliative care did not differ significantly from levels among those receiving usual/standard cancer care (five studies; SMD -0.11, 95% CI -0.26 to 0.03; participants analysed at post treatment = 762; evidence of very low certainty). Results from seven studies that analysed 1054 participants post treatment suggest a small effect for significantly lower symptom intensity in early palliative care compared with the control condition (SMD -0.23, 95% CI -0.35 to -0.10; evidence of low certainty). The type of model used to provide early palliative care did not affect study results. One RCT reported potential adverse events of early palliative care, such as a higher percentage of participants with severe scores for pain and poor appetite; the remaining six studies did not report adverse events in study publications. For these six studies, principal investigators stated upon request that they had not observed any adverse events. AUTHORS' CONCLUSIONS: This systematic review of a small number of trials indicates that early palliative care interventions may have more beneficial effects on quality of life and symptom intensity among patients with advanced cancer than among those given usual/standard cancer care alone. Although we found only small effect sizes, these may be clinically relevant at an advanced disease stage with limited prognosis, at which time further decline in quality of life is very common. At this point, effects on mortality and depression are uncertain. We have to interpret current results with caution owing to very low to low certainty of current evidence and between-study differences regarding participant populations, interventions, and methods. Additional research now under way will present a clearer picture of the effect and specific indication of early palliative care. Upcoming results from several ongoing studies (N = 20) and studies awaiting assessment (N = 10) may increase the certainty of study results and may lead to improved decision making. In perspective, early palliative care is a newly emerging field, and well-conducted studies are needed to explicitly describe the components of early palliative care and control treatments, after blinding of participants and outcome assessors, and to report on possible adverse events.

[Pain Management in Palliative Care]. / Schmerztherapie in der Palliativmedizin.

A consistent pain management together with treatment of dyspnoea belongs to the main issues in symptom control in particular in palliative thoracic oncology. Together with the medicamentous therapy the psychologic and social circumstances of the affected patients have to be considered as factors influencing the experience of pain. The therapeutic fundament according to the WHO guideline for cancer pain is the opiate based medicamentous adjustment combined with non-opioids. In principle, this should be performed preferably orally, as simply as possible, according to a fix drug schedule and individually adjusted to the needed dosage. Breakthrough pain has to be treated with rapidly efficacious, non-retarded analgetics. The typical adverse reaction profile for opiates like constipation and initial nausea should be considered prophylactically by applying concurrent medication with adjuvants. Co-analgesic drugs like anticonvulsiva or corticosteroids could support the analgetic effect and are used preferably in case of neuropathic pain. Primary aim in analgesic therapy is to achieve the best possible pain reduction and hence to safeguard quality of life.

Reflection of illness and strategies for handling advanced lung cancer - a qualitative analysis in patients and their relatives.

BACKGROUND: Lung cancer patients are often diagnosed in an advanced stage of disease. In a situation of palliative treatment, both patients and their relatives experience existential burden. Evidence suggests that multi-professional teams should deal with them as dyads. However, little is known about differences in their individual situation. The purpose of this study is to explore and compare reflections that arise out of the context of diagnosis and to compare how patients and their relatives try to handle advanced lung cancer. METHODS: Data was collected by qualitative interviews. A total of 18 participants, 9 patients diagnosed with advanced lung cancer (ICD- 10 C-34, stage IV) starting or receiving palliative treatment and 9 relatives were interviewed. Data was interpreted using qualitative content analysis. RESULTS: Reflection aspects were "thoughts about the cause", "meaning of belief" and "experience of inequity". Patients often experienced the diagnosis as inequity and were more receptive for believing in treatment success. The main strategies found were "repression", "positive attitude", "strong focus on the present" and "adjustment of life terms". Patient and relative dyads used the same strategies, but with different emphasis. That life time is limited was more frequently realized by relatives than by patients. CONCLUSION: While strategies used by relatives are similar to those of patients', they are less reflective and more pragmatic in terms of handling daily life and organizing care. The interviewed patients were mostly not able to takeover these tasks. To strong was their belief in treatment success, their repression of the future and the focus on the present. This implicates, that in terms of end-of-life care, relatives are important to reach patients who are often not receptive to this topic.