Prioritization and resource allocation in the context of the COVID-19 pandemic. Recommendations for colorectal and pancreatic cancer in Germany.

In the context of the COVID-19 pandemic, there has been a scarcity of resources with various effects on the care of cancer patients. This paper provides an English summary of a German guideline on prioritization and resource allocation for colorectal and pancreatic cancer in the context of the pandemic. Based on a selective literature review as well as empirical and ethical analyses, the research team of the CancerCOVID Consortium drafted recommendations for prioritizing diagnostic and treatment measures for both entities. The final version of the guideline received consent from the executive boards of nine societies of the Association of Scientific Medical Societies in Germany (AWMF), 20 further professional organizations and 22 other experts from various disciplines as well as patient representatives. The guiding principle for the prioritization of decisions is the minimization of harm. Prioritization decisions to fulfill this overall goal should be guided by 1. the urgency relevant to avoid or reduce harm; 2. the likelihood of success of the diagnostic or therapeutic measure advised; and 3. the availability of alternative treatment options. In the event of a relevant risk of harm as a result of prioritization, these decisions should be made by means of a team approach. Gender, age, disability, ethnicity, origin and other social characteristics, such as social or insurance status, as well as the vehemence of a patient's treatment request and SARS-CoV-2 vaccination status should not be used as prioritization criteria. The guideline provides concrete recommendations for 1. diagnostic procedures, 2. surgical procedures for cancer, and 3. systemic treatment and radiotherapy in patients with colorectal or pancreatic cancer within the context of the German healthcare system.

UNCAN.eu: Toward a European Federated Cancer Research Data Hub.

To enable a collective effort that generates a new level of UNderstanding CANcer (UNCAN.eu) [Cancer Discov (2022) 12 (11): OF1], the European Union supports the creation of a sustainable platform that connects cancer research across Member States. A workshop hosted in Heidelberg gathered European cancer experts to identify ongoing initiatives that may contribute to building this platform and discuss the governance and long-term evolution of a European Federated Cancer Data Hub.

Evaluating requests for physician-assisted suicide. A survey among German oncologists.

BACKGROUND: Cancer patients form a notable proportion of requestors for physician-assisted suicide (PAS). This manuscript provides data on German oncologists' views concerning due criteria for the assessment of requests for PAS and quality assurance. METHODS: The German Society of Haematology and Medical Oncology (DGHO) has conducted a survey among its members to elicit data about practices and views on regulating PAS in March 2021. Descriptive analysis and bivariate logistic regression of quantitative data on socio-demographic and other determinants possibly associated with respondents' views on PAS as well as content analysis of qualitative data were performed. RESULTS: About 57.1% (n = 425) of respondents (n = 745) indicated that they had been asked for information about PAS by patients. Information about palliative (92.7%; n = 651) and psychological care options (85.6%; n = 598) was deemed most important in cases of requests for PAS. More than half of the respondents (57.6%; n = 429) were in favour of a formal expert assessment of decisional capacity and about 33.4% (n = 249) favoured a time span of 14 days between the counselling and prescription of a lethal drug. There was no association between participants who received more requests and a preference for disclosing publicly their willingness to assist with suicide. A majority of respondents requested measures of quality assurance (71.3%; n = 531). CONCLUSION: According to respondents' views, the regulation of PAS will require diligent procedures regarding the assessment of decisional capacity and counselling. The findings suggest that the development of adequate and feasible criteria to assess the quality of practices is an important task.

Patients' Willingness to Provide Their Clinical Data for Research Purposes and Acceptance of Different Consent Models: Findings From a Representative Survey of Patients With Cancer.

BACKGROUND: Secondary use of clinical data for biomedical research purposes holds great potential for various types of noninterventional, data-driven studies. Patients' willingness to support research with their clinical data is a crucial prerequisite for research progress. OBJECTIVE: The aim of the study was to learn about patients' attitudes and expectations regarding secondary use of their clinical data. In a next step, our results can inform the development of an appropriate governance framework for secondary use of clinical data for research purposes. METHODS: A questionnaire was developed to assess the willingness of patients with cancer to provide their clinical data for biomedical research purposes, considering different conditions of data sharing and consent models. The Cancer Registry of the German federal state of Baden-Württemberg recruited a proportionally stratified random sample of patients with cancer and survivors of cancer based on a full census. RESULTS: In total, 838 participants completed the survey. Approximately all participants (810/838, 96.7%) showed general willingness to make clinical data available for biomedical research purposes; however, they expected certain requirements to be met, such as comparable data protection standards for data use abroad and the possibility to renew consent at regular time intervals. Most participants (620/838, 73.9%) supported data use also by researchers in commercial companies. More than half of the participants (503/838, 60%) were willing to give up control over clinical data in favor of research benefits. Most participants expressed acceptance of the broad consent model (494/838, 58.9%), followed by data use by default (with the option to opt out at any time; 419/838, 50%); specific consent for every study showed the lowest acceptance rate (327/838, 39%). Patients expected physicians to share their data (763/838, 91.1%) and their fellow patients to support secondary use with their clinical data (679/838, 81%). CONCLUSIONS: Although patients' general willingness to make their clinical data available for biomedical research purposes is very high, the willingness of a substantial proportion of patients depends on additional requirements. Taking these perspectives into account is essential for designing trustworthy governance of clinical data reuse and sharing. The willingness to accept the loss of control over clinical data to enhance the benefits of research should be given special consideration.

Sequential Geriatric Assessment in Older Patients with Colorectal Cancer during Chemotherapy: Subgroup Analysis of a Prospective, Multicenter Study EpiReal 75.

INTRODUCTION: Colorectal cancer (CRC) is a disease of older patients, but evidence-based guidelines for chemotherapy in older patients are scarce. Geriatric assessment (GA) evaluates a patient's functional status (FS) and helps in decision-making when choosing chemotherapy for older patients. However, the change of FS during chemotherapy is rarely studied as GA is mostly performed once instead of sequentially. METHODS: We performed a subgroup analysis of a prospective, multicenter study EpiReal 75. Patients aged ≥75 years with gastrointestinal malignancy prior to initiation of chemotherapy or receiving palliative chemotherapy were screened. We defined geriatric core assessments including the Eastern Cooperative Oncology Group score, Barthel's activities of daily living (ADL) scale, Lawton's instrumental activities of daily living (IADL) scale, and G-8 questionnaire, which were performed at baseline and repeated every 3 months. Quality of life (QoL) assessed by QLQ-C30 questionnaire was also re-evaluated every 3 months. We defined any deterioration in any of the geriatric parameters as unstable in the corresponding function. RESULTS: 28 patients with CRC were enrolled between April 2014 and December 2018. 20 patients were evaluable for statistical analysis with a mean age of 78.5 years (range, 75-88). Most patients received chemotherapy in palliative setting. During 3 months of chemotherapy, 25% of patients became more dependent as measured by ADL or IADL. During a median follow-up of 15 months, patients with unstable ADL or IADL had a significantly shorter overall survival (OS) than those with stable ADL or IADL (plogrank = 0.0055 and 0.0253, respectively), without a significant difference in progression-free survival (PFS). Also, unstable IADL correlated with a deterioration in aspects of QoL such as role functioning and emotional functioning (p = 0.0189 and 0.0239, respectively). 20% of patients experienced treatment-related grade 3 adverse events (AEs), no grade 4-5 AEs occurred. CONCLUSION: Sequential GA revealed changes in FS in older patients with CRC receiving chemotherapy. A deterioration of FS during chemotherapy did not influence PFS but had a negative impact on OS and QoL. It is therefore important to maintain FS in older patients with cancer, and regular performance of geriatric core assessments should be encouraged in the clinical practice.

Ethical challenges of precision cancer medicine.

Amongst common diseases, cancer is often both a leader in self-regulatory policy, or the field for contentious ethical issues such as the patenting of the BRCA1/2 genes. With the advent of genomic sequencing technologies, achieving precision cancer medicine requires prospective norms due to the large and varied sources of data involved. Here, we discuss the ethical and legal aspects of the policy debate around the relevant topics in precision cancer medicine: the return of incidental findings and sequencing raw data to patients, the communication of genetic results to patients' relatives, privacy and communication risks with concomitant oversight strategies, patient participation and consent models. We present the arguments and empirical data supporting specific policy solutions delineating still contested areas. What type of consent and oversight are required to acquire genomic data or to access it where desired, either by the participant/patient or third-party researchers? Most of the raw sequencing data is still uninterpretable and the variants revealed subject to reinterpretation over time. No doubt the ethical challenges of precision cancer medicine are a prototype of what's to come for other diseases. They are also paradigmatic for regulatory and ethical questions of the translational endeavors since the two worlds - basic science and patient care - are governed by different ethical and legal principles that need to be reconciled in precision cancer medicine.

Experience of Time and Subjective Age When Facing a Limited Lifetime: The Case of Older Adults with Advanced Cancer.

OBJECTIVES: We addressed two questions: (1) Does advanced cancer in later life affect a person's awareness of time and their subjective age? (2) Are awareness of time and subjective age associated with distress, perceived quality of life, and depression? METHODS: We assessed patients suffering terminal cancer (OAC, n = 91) and older adults free of any life-threatening disease (OA, n = 89), all subjects being aged 50 years or older. RESULTS: Older adults with advanced cancer perceived time more strongly as being a finite resource and felt significantly older than OA controls. Feeling younger was meaningfully related with better quality of life and less distress. In the OA group, feeling younger was also associated to reduced depression. Perceiving time as a finite resource was related to higher quality of life in the OA group. DISCUSSION: Major indicators of an older person's awareness of time and subjective aging differ between those being confronted with advanced cancer versus controls.

Patient-Reported Financial Distress in Cancer: A Systematic Review of Risk Factors in Universal Healthcare Systems.

Financial toxicity is a side effect of cancer that results from the perceived financial distress an individual may experience in the course of the disease. The purpose of this paper is to analyse underlying factors related to subjective financial distress in high-income countries with universal healthcare coverage. A systematic literature review was conducted to identify qualitative and quantitative studies of cancer patient-reported subjective financial distress by performing a search in the databases of PubMed, PsycINFO and CINAHL up to December 2020. A qualitative synthesis was performed linking the time-dependent occurrence of risk factors to derived categories of risk factors. Out of 4321 identified records, 30 quantitative and 16 qualitative studies were eligible. Classification of risk factors resulted in eight categories with a total of 34 subcategories. Subjective financial distress is primarily determined by pre-diagnosis sociodemographic- factors as well as financial and work factors that might change during the course of the disease. The design of healthcare and social security systems shapes the country-specific degree of subjective financial distress. Further research should focus on evolving multidisciplinary intervention schemes and multidimensional instruments for subjective financial distress to account for identified risk factors in universal healthcare systems more precisely.

Development and Evaluation of a Decision Aid to Support Patients' Participatory Decision-Making for Tumor-Specific and Palliative Therapy for Advanced Cancer: Protocol for a Pre-Post Study.

BACKGROUND: To support advanced cancer patients and their oncologists in therapeutic decisions, we aim to develop a decision aid (DA) in a multiphased, bicentric study. The DA aims to help patients to better understand risks and benefits of the available treatment options including the options of standard palliative care or cancer-specific treatment (ie, off-label drug use within an individual treatment plan). OBJECTIVE: This study protocol outlines the development and testing of the DA in a pre-post study targeting a heterogeneous population of advanced cancer patients. METHODS: In the first step, we will assess patients' information and decisional needs as well as the views of the health care providers regarding the content and implementation of the DA. Through a scoping review, we aim to analyze specific characteristics of the decision-making process and to specify the treatment options, outcomes, and probabilities. An interdisciplinary research group of experts will develop and review the DA. In the second step, testing of the DA (design and field testing) with patients and oncologists will be conducted. As a last step, we will run a pre-post design study with 70 doctor-patient encounters to assess improvements on the primary study outcome: patients' level of decisional conflict. In addition, the user acceptance of all involved parties will be tested. RESULTS: Interviews with cancer patients, oncologists, and health care providers (ie, nurses, nutritionists) as well as a literature review from phase I have been completed. The field testing is scheduled for April 2021 to August 2021, with the final revision scheduled for September 2021. The pre-post study of the DA and acceptance testing are scheduled to start in October 2021 and shall be finished in September 2022. CONCLUSIONS: A unique feature of this study is the development of a DA for patients with different types of advanced cancer, which covers a wide range of topics relevant for patients near the end of life such as forgoing cancer-specific therapy and switching to best supportive care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04606238; https://clinicaltrials.gov/ct2/show/NCT04606238. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24954.

Dealing with Family Conflicts in Decision-making in End-of-Life Care of Advanced Cancer Patients.

PURPOSE OF REVIEW: The family plays a significant role in end-of-life care and decision-making with advanced cancer patients. This non-systematic review aims to summarize the family role and possible emerging conflicts and problems related to family involvement in decisions with advanced cancer patients. RECENT FINDINGS: Four important domains were identified: (1) discordance between patients and caregivers' understanding of prognosis and goals of care; (2) internal family conflicts; (3) cultural differences regarding the role of the family in end-of life decision-making; (4) the burden on caregivers through caring for cancer patients. Based on the findings, we formulated some implications to consider for clinical practice. We suggest to involve the family in decision-making, to ascertain patients' wish for family involvement and if necessary, taking a mediator role between patients and their caregivers; to be aware of "invisible" family influence on patients' decisions; to assess systematically family burden and needs; to provide timely information, psychological support interventions and palliative care.

Multicenter Analysis of Treatment Outcomes for Systemic Therapy in Well Differentiated Grade 3 Neuroendocrine Tumors (NET G3).

Well-differentiated grade 3 neuroendocrine tumors (NET G3) have been distinguished from poorly differentiated neuroendocrine carcinomas (NEC) in the most current WHO classifications. Commonly applied first-line chemotherapy protocols with cisplatin or carboplatin in combination with etoposide (PE) are less effective in NET G3 than NEC. Suggested alternative treatment protocols have not been studied in first-line therapy of NET G3 so far. We performed a retrospective analysis of patients with NET G3 in the databases of 3 German cancer centers. Out of 142 patients, 136 patients received palliative first-line therapy: overall response rate (ORR) was 35.1% for PE (n = 37), 56.4% for FOLFOX (n = 39), 27.3% for temozolomide/capecitabine (TEM/CAP) (n = 22), 45.0% for streptozotocin/5-fluorouracil (STZ/5-FU) (n = 20), and 16.7% for other (n = 18). Median progression-free survival (PFS) for PE was 6.9 months. Compared to PE, PFS in the other treatment groups was 6.9 months for FOLFOX (p = 0.333), 12.0 months for TEM/CAP (p = 0.093), 4.8 months for STZ/5-FU (p = 0.919), and 14.1 months for other (p = 0.014). In a univariate setting, all non-PE patients combined showed a significantly prolonged PFS vs. PE (9.0 months; p = 0.049) which could not be confirmed in a multivariate analysis. In conclusion, NET G3 with FOLFOX showed the highest ORR, and with TEM/CAP showed the longest PFS. Further prospective evaluation of the optimal therapeutic strategy for this tumor entity is needed.

[Individual financial burden following a cancer diagnosis from the perspective of social services in Germany]. / Individuelle finanzielle Belastungen infolge einer Krebserkrankung aus der Perspektive von Sozialdiensten in Deutschland.

BACKGROUND: In addition to physical, psychological and social effects, economic effects and the associated financial burden of a cancer diagnosis may also gain in importance during prolonged disease progression. Counselling by social services is an important factor in coping with this burden. METHODS: People employed in social work in oncology were invited to participate in a survey. The survey comprises 16 items on the perception of financial burdens, changes in the relevance of the topic, risk factors and current counselling practice. RESULTS: 81% of the respondents reported that the financial burden arising from a cancer diagnosis is a relevant topic of consultation for at least half of the patients. For 55%, this topic has become more important in recent years, which is due to higher survival rates, an increased number of younger patients, and poorer social security and working conditions. DISCUSSION AND CONCLUSION: Despite comprehensive insurance coverage, the financial burden of cancer patients has also gained in importance in Germany and must be increasingly taken into account in everyday social service counselling. Due to numerous risk factors and complex reasons, further measures are required to enable the early identification of risk constellations and to improve the situation of those affected.

The COVID-19 Pandemic and Cancer Patients in Germany: Impact on Treatment, Follow-Up Care and Psychological Burden.

In response to the ongoing coronavirus disease 2019 (COVID-19) pandemic, governments imposed various measures to decrease the rate of disease spread, and health care policy makers prioritized resource allocation to accommodate COVID-19 patients. We conducted a cross-sectional online survey in Germany (July 2020-June 2021) to assess the frequency of changes to cancer care among cancer patients and to explore the psychological impact of the pandemic writ large. Cancer patients who contacted the Cancer Information Service (Krebsinformationsdienst, KID) of the German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ) via email were invited to complete an online questionnaire, capturing demographics, cancer specifics (e.g., type, disease phase, primary place of treatment, etc.), and any changes to their medical, follow-up, psycho-oncological or nursing care. General level of psychological distress was measured using the Hospital Anxiety and Depression Scale (HADS) along with face-validated items regarding worries and social isolation specific to the pandemic. In total, 13% of 621 patients reported a change to their treatment or care plan. Of those patients with changes, the majority of changes were made to follow-up care after treatment (56%), to monitoring during treatment (29%) and to psychological counseling (20%). Of the overall sample, more than half of patients (55%) reported symptoms of anxiety and 39% reported symptoms of depression. Patients with a change in cancer care were more likely to report symptoms of depression than those with no change (AOR: 2.18; 95% CI: 1.26-3.76). Concern about the pandemic affecting the quality of health care was a predictor of both anxiety (AOR: 2.76; 95% CI: 1.75-4.35) and depression (AOR: 2.15; 95% CI: 1.43-3.23). Results showed that the majority of cancer patients in our study did not experience a change in their cancer care. However, the level of anxiety and psycho-social burden of cancer patients during the pandemic was high throughout the study period. Our findings underscore the need for health care services and policy makers to assess and to attend cancer patients' medical needs, with added emphasis on patients' psychological and social well-being. This applies particularly in situations where the healthcare system is strained and prioritization is necessary.

"Often Relatives are the Key [ ]" -Family Involvement in Treatment Decision Making in Patients with Advanced Cancer Near the End of Life.

BACKGROUND: Family communication has been increasingly recognized as an important factor in decision making near the end of life. However, the role of the family in decision making is less studied in oncology settings, where most patients are conscious and able to communicate almost until dying. The aim of this study was to explore oncologists' and nurses' perceptions of family involvement in decision making about forgoing cancer-specific treatment in patients with advanced cancer. MATERIALS AND METHODS: Qualitative semistructured interviews with 22 oncologists and 7 oncology nurses were analyzed according to the grounded theory approach. The results were discussed against the background of the clinical and ethical debate on family role near the end of life. RESULTS: We could identify two approaches shared by both oncologists and nurses toward family involvement. These approaches could be partly explained by different perception and definition of the concept of patients' autonomy: (a) a patient-focused approach in which a patient's independence in decision making was the highest priority for oncologists and (b) a mediator approach with a family focus in which oncologists and nurses assigned an active role to patients' family in decision making and strived for building consensus and resolving conflicts. CONCLUSION: The main challenge was to involve family, increasing their positive influences on the patient and avoiding a negative one. Thereby, the task of both oncologists and oncology nurses is to support a patient's family in understanding of a patient's incurable condition and to identify a patient's preference for therapy. IMPLICATIONS FOR PRACTICE: This study focused on oncologists' and oncology nurses' perceptions of family involvement in decision making about treatment limitation in patients with advanced cancer who are able to communicate in a hospital setting. Oncologists and oncology nurses should be aware of both positive aspects and challenges of family involvement. Positive aspects are patients' emotional support and support in understanding and managing the information regarding treatment decisions. Challenges are diverging family preferences with regard to treatment goals that might become a barrier to advanced care planning, a possible increased psychological burden for the family. Especially challenging is involving the family of a young patient because increased attention, more time investment, and detailed discussions are needed.

Completion rate and impact on physician-patient relationship of video consultations in medical oncology: a randomised controlled open-label trial.

BACKGROUND: Mobile phone video call applications generally did not undergo testing in randomised controlled clinical trials prior to their implementation in patient care regarding the rate of successful patient visits and impact on the physician-patient relationship. METHODS: The National Center for Tumour Diseases (NCT) MOBILE trial was a monocentric open-label randomised controlled clinical trial of patients with solid tumours undergoing systemic cancer therapy with need of a follow-up visit with their consulting physician at outpatient clinics. 66 patients were 1:1 randomised to receive either a standard in-person follow-up visit at outpatient clinics or a video call via a mobile phone application. The primary outcome was feasibility defined as the proportion of patients successfully completing the first follow-up visit. Secondary outcomes included success rate of further video calls, time spent by patient and physician, patient satisfaction and quality of physician-patient relationship. FINDINGS: Success rate of the first follow-up visit in the intention-to-treat cohort was 87.9% (29 of 33) for in-person visits and 78.8% (26 of 33) for video calls (relative risk: RR 0.90, 95% CI 0.70 to 1.13, p=0.51). The most common reasons for failure were software incompatibility in the video call and no-show in the in-person visit arm. The success rate for further video visits was 91.7% (11 of 12). Standardised patient questionnaires showed significantly decreased total time spent and less direct costs for patients (Δmean -170.8 min, 95% CI -246 min to -95.5 min), p<0.0001; Δmean -€14.37, 95% CI -€23.9 to -€4.8, p<0.005) and comparable time spent for physicians in the video call arm (Δmean 0.5 min, 95% CI -5.4 min to 6.4 min, p=0.86). Physician-patient relationship quality mean scores assessed by a validated standardised questionnaire were higher in the video call arm (1.13-fold, p=0.02). INTERPRETATION: Follow-up visits with the tested mobile phone video call application were feasible but software compatibility should be critically evaluated. TRIAL REGISTRATION NUMBER: DRKS00015788.

Late decisions about treatment limitation in patients with cancer: empirical analysis of end-of-life practices in a haematology and oncology unit at a German university hospital.

BACKGROUND: Decisions to limit treatment (DLTs) are important to protect patients from overtreatment but constitute one of the most ethically challenging situations in oncology practice. In the Ethics Policy for Advance Care Planning and Limiting Treatment study (EPAL), we examined how often DLT preceded a patient's death and how early they were determined before (T1) and after (T2) the implementation of an intrainstitutional ethics policy on DLT. METHODS: This prospective quantitative study recruited 1.134 patients with haematological/oncological neoplasia in a period of 2×6 months at the University Hospital of Munich, Germany. Information on admissions, discharges, diagnosis, age, DLT, date and place of death, and time span between the initial determination of a DLT and the death of a patient was recorded using a standardised form. RESULTS: Overall, for 21% (n=236) of the 1.134 patients, a DLT was made. After implementation of the policy, the proportion decreased (26% T1/16% T2). However, the decisions were more comprehensive, including more often the combination of 'Do not resuscitate' and 'no intense care unit' (44% T1/64% T2). The median time between the determination of a DLT and the patient's death was similarly short with 6 days at a regular ward (each T1/T2) and 10.5/9 (T1/T2) days at a palliative care unit. For patients with solid tumours, the DLTs were made earlier at both regular and palliative care units than for the deceased with haematological neoplasia. CONCLUSION: Our results show that an ethics policy on DLT could sensitise for treatment limitations in terms of frequency and extension but had no significant impact on timing of DLT. Since patients with haematological malignancies tend to undergo intensive therapy more often during their last days than patients with solid tumours, special attention needs to be paid to this group. To support timely discussions, we recommend the concept of advance care planning.

Caregivers' role in using a personal electronic health record: a qualitative study of cancer patients and caregivers in Germany.

BACKGROUND: Particularly in the context of severe diseases like cancer, many patients wish to include caregivers in the planning of treatment and care. Many caregivers like to be involved but feel insufficiently enabled. This study aimed at providing insight into patients' and caregivers' perspectives on caregivers' roles in managing the patient portal of an electronic personal health record (PHR). METHODS: A descriptive qualitative study was conducted comprising two study phases: (1) Usability tests and interviews with patients with cancer and caregivers (2) additional patient interviews after a 3-month-pilot-testing of the PHR. For both study parts, a convenience sample was selected, focusing on current state of health and therapy process and basic willingness to participate and ending up with a mixed sample as well as saturation of data. All interviews were audio-recorded, pseudonymized, transcribed verbatim and qualitatively analyzed. RESULTS: Two main categories emerged from qualitative data: 'Caregivers' role' and 'Graduation of access rights' - consisting of four subcategories each. The interviewed patients (n = 22) and caregivers (n = 9) felt that the involvement of caregivers is central to foster the acceptance of a PHR for cancer patients. However, their role varied from providing technical support to representing patients, e.g. if the patient's state of health made this necessary. Heterogeneous opinions emerged regarding the question whether caregivers should receive full or graduated access on a patient's PHR. CONCLUSIONS: In order to support the patient and to participate in the care process, caregivers need up-to-date information on the patient's health and treatment. Nevertheless, some patients do not want to share all medical data with caregivers, which might strain the patient-caregiver relationship. This needs to be considered in development and implementation of personal health records. Generally, in the debate on patient portals of a personal health record, paying attention to the role of caregivers is essential. By appreciating the important relationship between patients and caregivers right from the beginning, implementation, of a PHR would be enhanced. TRIAL REGISTRATION: ISRCTN85224823 . Date of registration: 23/12/2015 (retrospectively registered).

The patient-level effect of the cost of Cancer care - financial burden in German Cancer patients.

BACKGROUND: Financial toxicity of cancer has so far been discussed primarily in the US health care system and is associated with higher morbidity and mortality. In European health care systems, the socio-economic impact of cancer is poorly understood. This study investigates the financial burden and patient-reported outcomes of neuroendocrine (NET) or colorectal (CRC) cancer patients at a German Comprehensive Cancer Center. METHODS: This prospective cross-sectional study surveyed 247 advanced stage patients (n = 122 NET/n = 125 CRC) at the National Center for Tumor Diseases, in Germany about cancer-related out-of-pocket costs, income loss, distress, and quality of life. Multiple linear regression analysis was performed to demonstrate the effects of economic deterioration on patients' quality of life and distress. RESULTS: 81% (n = 199) of the patients reported out-of-pocket costs, and 37% (n = 92) income loss as a consequence of their disease. While monthly out-of-pocket costs did not exceed 200€ in 77% of affected patients, 24% of those with income losses reported losing more than 1.200€ per month. High financial loss relative to income was significantly associated with patients' reporting a worse quality of life (p < .05) and more distress (p < .05). CONCLUSIONS: Financial toxicity in third-party payer health care systems like Germany is caused rather by income loss than by co-payments. Distress and reduced quality of life due to financial problems seem to amplify the burden that already results from a cancer diagnosis and treatment. If confirmed at a broader scale, there is a need for targeted support measures at the individual and system level.

Do Researchers in Empirical Ethics Studies Have a Duty to Act Upon their Findings? Case Study in End-of-Life Decision Making.

The outlined empirical study on the decision-making process concerning the limitation of life-prolonging treatment (DLT) in patients with advanced cancer at a University hospital setting triggered some new questions for research ethics with respect to studies using empirical methods in medical ethics. The analyzed data of the study showed that less than half of the patients were involved in DLT. Deciding against CPR (cardiopulmonary resuscitation) and transferal to the ICU (intensive care unit) without informing and explaining it to the perfectly competent patient can be regarded as a violation of the ethical principle of respect for autonomy. This is what the embedded researcher witnessed throughout the study recruitment and data acquisition, as the noninvolvement of patients was not just a result of the final data analysis. The ethical question raised in this situation was as follows: Does the embedded researcher has a moral duty to intervene when she witnesses that ethical standards are not upheld?

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.