Patients with Advanced or Metastasised Non-Small-Cell Lung Cancer with Viscum album L. Therapy in Addition to PD-1/PD-L1 Blockade: A Real-World Data Study.

Immunotherapy with PD-1/PD-L1 inhibitors has significantly improved the survival rates of patients with metastatic non-small-cell lung cancer (NSCLC). Results of a real-world data study investigating add-on VA (Viscum album L.) to chemotherapy have shown an association with the improved overall survival of patients with NSCLC. We sought to investigate whether the addition of VA to PD-1/PD-L1 inhibitors in patients with advanced or metastasised NSCLC would have an additional survival benefit. In the present real-world data study, we enrolled patients from the accredited national registry, Network Oncology, with advanced or metastasised NSCLC. The reporting of data was performed in accordance with the ESMO-GROW criteria for the optimal reporting of oncological real-world evidence (RWE) studies. Overall survival was compared between patients receiving PD-1/PD-L1 inhibitor therapy (control, CTRL group) versus the combination of anti-PD-1/PD-L1 therapy and VA (combination, COMB group). An adjusted multivariate Cox proportional hazard analysis was performed to investigate variables associated with survival. From 31 July 2015 to 9 May 2023, 415 patients with a median age of 68 years and a male/female ratio of 1.2 were treated with anti-PD-1/PD-L1 therapy with or without add-on VA. Survival analyses included 222 (53.5%) patients within the CRTL group and 193 (46.5%) in the COMB group. Patients in the COMB group revealed a median survival of 13.8 months and patients in the CRTL group a median survival of 6.8 months (adjusted hazard ratio, aHR: 0.60, 95% CI: 0.43-0.85, p = 0.004) after adjustment for age, gender, tumour stage, BMI, ECOG status, oncological treatment, and PD-L1 tumour proportion score. A reduction in the adjusted hazard of death by 56% was seen with the addition of VA (aHR 0.44, 95% CI: 0.26-0.74, p = 0.002) in patients with PD-L1-positive tumours (tumour proportion score > 1%) treated with first-line anti-PD-1/PD-L1 therapy. Our findings suggest that add-on VA correlates with improved survival in patients with advanced or metastasised NSCLC who were treated with PD-1/PD-L1 inhibitors irrespective of age, gender, tumour stage, or oncological treatment. The underlying mechanisms may include the synergistic modulation of the immune response. A limitation of this study is the observational non-randomised study design, which only allows limited conclusions to be drawn and prospective randomised trials are warranted.

Does the Argentine Tango Sustainably Improve Cancer-Associated Fatigue and Quality of Life in Breast Cancer Survivors?

BACKGROUND: Chronic cancer-related fatigue is difficult to manage in breast cancer survivors. The tango trial showed that a six-week tango Argentino program was effective in reducing fatigue and improving quality of life, and here we investigated the sustainability of this tango program for breast cancer survivors. METHODS: Stage I-III breast cancer survivors with increased fatigue symptoms were analyzed. The fifty participants in the tango trial were compared with a control cohort (n = 108) who did not participate in the tango program. Using the European Organization for Research and Treatment of Cancer Questionnaire C30 (EORTC-QLQ-C30) and the German version of the cancer fatigue scale (CFS-D) self-reported quality of life parameters were assessed and longitudinal changes, correlations, and association factors were calculated. RESULTS: Significant improvements in fatigue (p = 0.006), physical functioning (p = 0.01), and diarrhea (p = 0.04) persisted in the 50 Tango participants at 6 months, but not in the control cohort. Twelve months after joining the tango program, increased fatigue was associated with reduced sporting activities (p = 0.0005), but this was not the case for tango dancing. CONCLUSIONS: The present results suggest that tango may be appropriate as a component of early supportive and follow-up care programs, to promote health-related quality of life and physical activity and also eventually to improve long-term clinical outcomes of breast cancer survivors. TRIAL REGISTRATION: Trial registration numbers DRKS00013335 on 27 November 2017 and DRKS00021601 on 21 August 2020 retrospectively registered.

Self-Reported Baseline Quality of Life Mirrors Treatment-Specific Characteristics of Cancer Patients.

BACKGROUND: Baseline quality of life (bQL) has been shown to be a predictor of the clinical outcome of oncological patients. The primary objective of the present study was to examine the role of bQL as a treatment predictor in oncological patients. METHODS: In this prospective study, all-stage cancer patients registered in the Network Oncology registry were enrolled, and their bQL at diagnosis was evaluated. RESULTS: Five hundred and thirty-eight oncological patients were eligible (median age 64 years). We show that survival-predicting bQL variables such as pain, low physical functioning or financial burden at tumor diagnosis were linked to lower systemic treatment (p = 0.03), reduced surgery (p = 0.007) or reduced oncological treatment compliance (0.01), respectively. Lastly, female gender and older cancer patients exhibited a tempered bQL. CONCLUSION: Our study is one of the first to reveal that bQL at tumor diagnosis is significantly associated with the prediction of oncological treatment with distinctive age- and gender-related patterns. Our results emphasize the need to address the physical, psychosocial, and financial burden of cancer patients prior to their oncological treatment with respect to age and gender. The associations found here pave the way for early integration of patient-reported outcomes into oncological supportive concepts.

Evaluation of quality of life in breast cancer patients who underwent breast-conserving surgery or mastectomy using real-world data.

BACKGROUND: Due to advances in the fight against breast cancer, aesthetic aspects and the prevention of breast deformities are playing an important role in surgical procedures. Currently the main form of breast cancer surgery is breast-conserving surgery (BCS), and even if mastectomy (MAS) is required, oncoplastic surgery and reconstruction options can improve outcomes, including health-related quality of life (QoL) of cancer patients. The purpose of this study was to assess whether surgery options induce different outcomes in self-reported QoL in guide-line treated breast cancer patients of the Network Oncology (NO). METHODS: This prospective Real-World-Data (RWD) study was conducted using data from the NO-clinical registry. QoL was assessed by evaluation of the European Organization of Research and Treatment Health-Related Quality of Life Core Questionnaire scale (EORTC QLQ-C30). Association factors between type of surgery options, without or with immediate breast reconstructions the EORTC QLQ-C30-scales at baseline after surgery, 6, 12, and 24 months later were analyzed with adjusted multivariate regression analysis, considering age, cancer stage, and treatment regimens, using software R. RESULTS: A total of 623 primary breast cancer patients (all tumor stages, median age 58 (ICR: 50-68) diagnosed and guide-line treated between 2013 and 2021), 524 BCS and 99 MAS, 24 of whom received immediate breast reconstruction (MBR), were eligible for analyses. Compared with BCS patients, MBR patients self-reported considerably lower global health, physical and social functioning, and higher burden of pain and financial difficulties at baseline. In later follow-up surveys, functional scales increased and symptoms decreased in all patients, and the differences between MAS and BCS equalized. Longitudinal analyses after 24 months were obtained from 258 patients and revealed that compared to 224 BCS, the 34 MAS patients reported increased social functioning (p = 0.04). CONCLUSIONS: At 24 months after MAS, breast cancer patients' QoL improved compared with BCS, although impairments in QoL were reported immediately after MAS. A growing expertise in surgical procedures as well as supportive care is critical to optimizing patients' well-being. These findings may be considered when counseling breast cancer patients pre- and post-surgery. TRIAL REGISTRATION NUMBER: DRKS00013335 on 27/11/2017 retrospectively registered.

Efficacy of Tango Argentino for Cancer-Associated Fatigue and Quality of Life in Breast Cancer Survivors: A Randomized Controlled Trial.

BACKGROUND: Persistent impairments of quality of life-in particular, cancer-associated fatigue-are a major limitation for breast cancer survivors. As physical activity and mindfulness interventions have been shown to be effective in reducing fatigue symptoms, we investigated the efficacy of a six-week Argentine tango program. METHODS: A randomized controlled trial was conducted with 60 breast cancer survivors diagnosed with stage I-III tumors 12-48 months prior to study enrollment and who had increased symptoms of fatigue. The participants were randomly assigned with a 1:1 allocation to either the tango or the waiting group. The treatment consisted of six weeks of supervised weekly one-hour tango group-sessions. Self-reported fatigue and further quality of life parameters were assessed at baseline and six weeks post-baseline. Longitudinal changes, correlations, Cohen's D (d) effect sizes, and association factors were also calculated. RESULTS: Superiority of the tango intervention over the waiting list control was found in terms of improvement in fatigue (d = -0.64; 95%CI, -1.2 to -0.08; p = 0.03), especially cognitive fatigue. In addition, a superiority of the tango intervention over the waiting list was found in the improvement of diarrhea (d = -0.69; 95%CI, -1.25 to -0.13; p = 0.02). A pooled pre-post analysis of the 50 participants completing the six-week tango program revealed a close to 10% improvement of fatigue (p = 0.0003), insomnia (p = 0.008) and further quality of life outcomes. Adjusted multivariate linear regression analyses revealed the greatest improvements for participants who were more active in sports. In particular, survivors who received endocrine therapies, were obese, or had no prior dance experience seemed to especially benefit from the tango program. CONCLUSIONS: This randomized controlled trial demonstrated that a six-week Argentine tango program improves fatigue in breast cancer survivors. Further trials are warranted to determine whether such improvements lead to better long-term clinical outcomes. TRIAL REGISTRATION: trial registration number DRKS00021601. Retrospectively registered on 21 August 2020.

A prospective phase IIA multicenter double-blinded randomized placebo-controlled clinical trial evaluating the efficacy and safety of inhaled Tobramycin in patients with ventilator-associated pneumonia (iToVAP).

OBJECTIVE: Treatment of ventilated pneumonia is often unsuccessful, even when patients are treated according to current guidelines. Therefore, we aimed to investigate the efficacy of the adjunctive inhaled Tobramycin in patients with pneumonia caused by Gram-negative pathogens in addition to the standard systemic treatment. DESIGN: Prospective, multicenter, double-blinded, randomized, placebo-controlled clinical trial. SETTING: 26 patients in medical and surgical ICUs. PATIENTS: Patients with ventilator-associated pneumonia caused by Gram-negative pathogens. MEASUREMENT AND MAIN RESULTS: Fourteen patients were assigned to the Tobramycin Inhal group and 12 patients to the control group. The microbiological eradication of the Gram-negative pathogens was significantly higher in the intervention group than in the control group (p < 0.001). The probability of eradication was 100% in the intervention group [95% Confidence Interval: 0.78-1.0] and 25% in the control group [95% CI: 0.09-0.53]. The increased eradication frequency was not associated with increased patient survival. CONCLUSION: Inhaled aerosolized Tobramycin demonstrated clinically meaningful efficacy in patients with Gram-negative ventilator-associated pneumonia. The probability of eradication in the intervention group was 100%. However, the successful eradication was not associated with a reduction in systemic anti-infective therapy, a shorter ICU stay, or even a survival benefit. In the presence of multidrug-resistant Gram-negative pathogens that are sensitive only to colistin and/or aminoglycosides, supplemental inhaled therapy with nebulizers suitable for this purpose should be considered in addition to systemic antibiotic therapy.

Evaluation of quality of life in lung cancer patients receiving radiation and Viscum album L.: a real-world data study.

BACKGROUND: Lung cancer (LC) is associated with high mortality and poor quality of life (QoL). The disease as well as oncological treatments such as radiation and chemotherapy with adverse effects can impair the QoL of patients. Add-on treatment with extracts of Viscum album L. (white-berry European mistletoe, VA) has been shown to be feasible and safe and to improve the QoL of cancer patients. The aim of this study was to analyze the changes in QoL of LC patients being treated with radiation according to oncological guidelines and add-on VA treatment in a real-world setting. METHODS: A real-world data study was conducted using registry data. Self-reported QoL was assessed by the evaluation of the European Organization of Research and Treatment Health-Related Quality of Life Core Questionnaire scale (EORTC QLQ-C30). Adjusted multivariate linear regression analyses were performed to analyze factors associated with changes in QoL at 12 months. RESULTS: A total of 112 primary LC patients (all stages, 92% non-small-cell lung cancer, median age 70 (ICR: 63-75)), answered the questionnaires at first diagnosis and 12 months later. Assessment of 12 months changes in QoL revealed significant improvement of 27 points for pain (p = 0.006) and 17 points for nausea/vomiting (p = 0.005) in patients who received combined radiation and VA. In addition, significant improvements of 15 to 21 points for role (p = 0.03), physical (p = 0.02), cognitive (p = 0.04), and social functioning (p = 0.04) were observed in guideline treated patients receiving no radiation but add-on VA. CONCLUSIONS: Add-on VA therapy reveals supportive effects for the QoL of LC patients. Particularly in combination with radiation a significant reduction in pain and nausea/ vomiting has been observed. Trial registration The study received ethics approval and was retrospectively registered (DRKS00013335 on 27/11/2017).

Safety of Combined Targeted and Helixor®Viscum album L. Therapy in Breast and Gynecological Cancer Patients, a Real-World Data Study.

BACKGROUND: Newer personalized medicines including targeted therapies such as PARP inhibitors and CDK 4/6 inhibitors have been shown to improve the survival of breast and gynaecological cancer patients. However, efficacy outcomes may be ham5pered by treatment discontinuation due to targeted therapy-related adverse drug reactions or resistance. Studies have suggested that add-on mistletoe (Viscum album L., VA) improves the quality of life and ameliorates the cytotoxic side effects of standard oncological therapy in cancer patients. The primary objective of this real-world data study was to determine the safety profile of targeted therapy in combination with add-on Helixor® VA therapy compared to targeted therapy alone in breast and gynecological cancer patients. METHODS: The present study is a real-world data observational cohort study utilizing demographic and treatment data from the accredited national Network Oncology (NO) registry. The study has received ethics approval. The safety profile of targeted therapies with or without Helixor® VA therapy and safety-associated variables were evaluated by univariate and adjusted multivariable regression analyses. RESULTS: All stages of breast and gynecological cancer patients (n = 242) were on average 54.5 ± 14.2 years old. One hundred and sixty patients (66.1%) were in the control (CTRL, targeted therapy) and 82 patients (33.9%) were in the combinational (COMB, targeted plus Helixor® VA therapy) group. The addition of Helixor® VA did not hamper the safety profile (χ2 = 0.107, p-value = 0.99) of targeted therapy. Furthermore, no adverse events and a trend towards an improved targeted therapy adherence were observed in the COMB group. CONCLUSIONS: The present study is the first of its kind showing the applicability of Helixor® VA in combination with targeted therapies. The results indicate that add-on Helixor® VA does not negatively alter the safety profile of targeted therapies in breast and gynaecological cancer patients.

Factors Associated with Self-Reported Post/Long-COVID-A Real-World Data Study.

Evidence suggests that Post/Long-COVID (PLC) is associated with a reduced health-related quality of life, however little knowledge exists on the risk factors that contribute to PLC. The objective of this prospective real-world data study was to evaluate factors associated with PLC using national online survey data. Adjusted multivariable regression analyses were performed using the software R. Between 14 April and 15 June 2021, 99 registered individuals reported to have suffered from PLC symptoms and the most common PLC symptoms reported were fatigue, dyspnoea, decreased strength, hyposmia, and memory loss. The odds of individuals suffering from COVID-19-associated anxiety, hyposmia, or heart palpitations developing PLC were eight times (OR 8.28, 95% CI 1.43−47.85, p < 0.01), five times (OR 4.74, 95% CI 1.59−14.12, p < 0.005), or three times (OR 2.62, 95% CI 1.72−3.99, p < 0.01) higher, respectively, than of those who had not experienced these symptoms. Individuals who experienced fatigue while having COVID-19 were seven times more likely to develop PLC fatigue than those who had not (OR 6.52, 95% CI: 4.29−9.91, p < 0.0001). Our findings revealed that 13% of the individuals who had previously suffered from COVID-19 subsequently reported having PLC. Furthermore, COVID-19-associated anxiety, hyposmia, heart palpitations, and fatigue were, among others, significant determinants for the development of PLC symptoms. Hyposmia has not previously been reported as an independent predictive factor for PLC. We suggest closely monitoring patients with COVID-19-induced fatigue, heart palpitations, and anxiety, as these symptoms may be predictors of PLC symptoms, including fatigue.

New multimodal intervention to reduce irritable bowel syndrome (IBS) severity symptoms-Pilot study with a 12 month follow-up.

INTRODUCTION: Irritable bowel syndrome (IBS) is characterized by patients' high level of suffering. Up to 60% of patients with IBS have symptoms of anxiety or depression and only little attention has been paid to their specific requirements. Anthroposophical multimodal therapy (AMT) has been shown to significantly improve health-related quality of life of patients with high symptomatic burden. OBJECTIVE: The aim of this pilot study was to find out whether AMT meets the needs of IBS patients and the interactions of AMT with IBS, depression and anxiety. METHODS: Patients with diagnosed IBS were included in a feasibility study and received 12 sessions of AMT over 8 weeks (drks.de, DRKS00016890). The primary endpoint was the change of the IBS severity score (IBS-SSS) and changes were calculated by linear mixed effects analyses. The secondary endpoints were changes of self-reported PHQ-9 and GAD-7 for mental comorbidity as well as self-valued effectiveness and satisfaction of AMT. RESULTS: Thirty-six patients, 89% female, were included in the study. AMT was successfully applied to IBS patients (-45 points in the IBS-SSS, p < .05). AMT had a large positive effect (-84 points in IBS-SSS, p < .003) on patients without anxiety or depression. Over time, patients with higher anxiety scores worsened with regard to their IBS compared to patients with depression and without mental comorbidity. The AMT effect was maintained at a 12 month follow up and both mentally affected and unaffected patients, had even lower IBS severity than shortly after AMT. AMT modules were rated by IBS patients as very effective. CONCLUSION: Our findings suggest that an 8-week program of AMT improves the severity of IBS with an ongoing effect at a 12 month follow-up. Especially for patients without psychological comorbidities, AMT is very successful. Future IBS therapies should incorporate a modified multimodal concept with stronger psychological therapy modules in parallel for patients with depression and anxiety.

Real-World Evidence-Current Developments and Perspectives.

Real-world evidence (RWE) is increasingly involved in the early benefit assessment of medicinal drugs. It is expected that RWE will help to speed up approval processes comparable to RWE developments in vaccine research during the COVID-19 pandemic. Definitions of RWE are diverse, marking the highly fluid status in this field. So far, RWE comprises information produced from data routinely collected on patient's health status and/or delivery of health care from various sources other than traditional clinical trials. These sources can include electronic health records, claims, patient-generated data including in home-use settings, data from mobile devices, as well as patient, product, and disease registries. The aim of the present update was to review current RWE developments and guidelines, mainly in the U.S. and Europe over the last decade. RWE has already been included in various approval procedures of regulatory authorities, reflecting its actual acceptance and growing importance in evaluating and accelerating new therapies. However, since RWE research is still in a transition process, and since a number of gaps in this field have been explored, more guidance and a consented definition are necessary to increase the implementation of real-world data.

Correction: Overall survival of stage IV non-small cell lung cancer patients treated with Viscum album L. in addition to chemotherapy, a real-world observational multicenter analysis.

[This corrects the article DOI: 10.1371/journal.pone.0203058.].

Viscum album L. Therapy in Oncology: An Update on Current Evidence.

BACKGROUND: A majority of oncological patients apply add-on white-berry European mistletoe (Viscum album L., VA) extracts to reduce disease- and treatment-related symptoms and to improve health-related quality of life (HRQL). VA extracts exert various antitumor, pro-apoptotic, anti-proliferative, and immunomodulatory effects. Two current meta-analyses attribute life-prolonging and HRQL-improving properties to additive VA therapy. The aim of the present update was to review the current knowledge on VA extracts in clinical oncology. Hereby, we concentrated on studies with the highest clinical relevance in the field of lung, gastric, colorectal and pancreatic, gynaecological, as well as breast cancer applying the anthroposophical mistletoe preparations. SUMMARY: The present update provides a brief overview regarding the use of VA preparations in clinical oncology reviewing current guidelines, systematic reviews, randomized controlled and real-world data studies. We have searched the pubmed.gov database of the National Library of Medicine with the search terms "mistletoe" and "cancer." We found good evidence of add-on VA therapy to improve the HRQL of patients with breast cancer (American Society of Clinical Oncology - endorsed Society for Integrative Oncology guideline) and of HRQL-improving and survival-prolonging properties of VA therapy in pancreatic cancer. In the field of gastrointestinal, gynaecological, and lung cancer, new or updating integrative and/or oncological guidelines should consider clear recommendations on integrative therapies including VA therapy. Nevertheless, further clinical and real-world data trials need to be performed in this field. KEY MESSAGES: Evidence for add-on VA treatment for the improved management of cancer and cancer-related side effects is accumulating. Patients with breast cancer: good evidence for add-on VA therapy to improve the HRQL of oncological patients. Patients with pancreatic cancer: good evidence for add-on VA to improve HRQL and prolong survival. Patients with gastrointestinal, gynaecological, and lung cancer: update of guidelines is recommended with regards to integrative oncological therapies including add-on VA.

TANGO: effect of tango Argentino on cancer-associated fatigue in breast cancer patients-study protocol for a randomized controlled trial.

BACKGROUND: The majority of breast cancer patients suffer from persistent impairments after completion of their primary oncological therapy. Cancer-related fatigue (CRF) in particular is a multidimensional syndrome having a profound negative impact on the quality of life. To counter CRF symptoms, physical activities are suggested as first-line interventions, mind-body therapies have been shown to be effective, and music therapy can also reduce anxiety and stress in breast cancer patients. Tango therapy that combines various elements can have an impact on physical, psychological, and cognitive abilities and could therefore have a beneficial effect on breast cancer patients. The purpose of this study is to investigate whether a 6-week tango module is suited as a therapeutic approach for people after primary breast cancer therapy to favorably influence their quality of life, especially CRF levels. METHODS: Sixty patients with a diagnosis for stage I-III breast cancer 12-48 months before enrollment and with CRF (age > 18) will be recruited and randomized 1:1 to a tango or a waiting-list group. Movement concepts using elements of Argentine tango (self-awareness, musical and spatial perception, self-perception, playfulness, shared experience) will be examined with the participants during six consecutive weekly 1-h tango sessions. The primary outcome will be the improvement of CRF (German version of the Cancer Fatigue Scale), and the secondary outcomes will be the improvement in sleep quality (Pittsburgh Sleep Quality Index) and quality of life (EORTC-QLQ-C30). Patient-reported outcomes will be measured at baseline and 6 weeks later; follow-up will be performed 6, 12, and 24 months after baseline. An evaluation will be performed by means of descriptive data analyses. DISCUSSION: Argentine tango, as a music-based movement therapy, can influence different skills and may improve several outcomes. The therapeutic use of Argentine tango in the care of breast cancer patients has not yet been reported. It is anticipated that participants receiving the tango module will have improved CRF, sleep, and quality of life scores compared to a waitlist control. TRIAL REGISTRATION: German Clinical Trials Registry (DRKS) DRKS00021601 . Retrospectively registered on 21 August 2020.

School Teachers' Self-Reported Fear and Risk Perception during the COVID-19 Pandemic-A Nationwide Survey in Germany.

With the coronavirus disease 2019 (COVID-19) cases peaking and health systems reaching their limits in winter 2020/21, schools remained closed in many countries. To better understand teachers' risk perception, we conducted a survey in Germany. Participants were recruited through various associations and invited to take part in a cross-sectional COVID-19-specific online survey. Descriptive statistical analysis was performed. Factors associated with teachers' fears of contracting the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) were evaluated with an adjusted multivariable regression analysis. The median age of the 6753 participating teachers was 43 years, and 77% were female. Most teachers worked in high schools (29%) and elementary schools (26%). The majority of participants (73%) feared contracting SARS-CoV-2 at school, while 77% intended to receive their COVID-19 vaccination. Ninety-eight percent considered students to pose the greatest risk. Female and younger teachers were significantly more anxious to get infected and teachers who opposed the re-opening of schools had significantly higher odds of being more anxious (p < 0.001). To the authors' knowledge, this is the first study to describe teachers' risk perception of COVID-19 and their attitudes towards vaccinations in a nationwide survey. The anxiety correlates with the COVID-19 protection measures demanded and appears to be a driving factor rather than rational logic.

Assessment of integrative non-pharmacological interventions and quality of life in breast cancer patients using real-world data.

BACKGROUND: Treatments with non-pharmacological interventions (NPIs), comprising art and exercise therapies, nursing interventions, and educational components, are considered to improve quality of life of cancer patients. The aim of this study was to assess the longitudinal changes in self-reported quality of life of breast cancer patients receiving an integrative medicine program consisting of hospital-based NPIs and standard oncological treatments. METHODS: This real-world data study was conducted using data from the Network Oncology clinical registry of the Gemeinschaftskrankenhaus Havelhöhe. Primary breast cancer patients of all tumor stages, who answered the European Organization of Research and Treatment Health-Related Quality of Life Core Questionnaire scale (EORTC QLQ-C30) at first diagnosis and 12 months later, were included. Association factors between received NPIs and longitudinal EORTC QLQ-C30-changes were analyzed with additive non-parametric regression tests, considering treatment regimens and demographic variables, using the software R. RESULTS: A total of 231 primary breast cancer patients were enrolled and separate regression analyses were carried out. Significant associations between the received NPIs elaborate consultations and life review, nursing compresses, music and eurythmy therapy and improvements of 8-13 points for global health, all five functional EORTC-scales, and symptoms fatigue, dyspnea, insomnia, and financial difficulties were observed. CONCLUSION: Our findings support the beneficial impact of NPIs for breast cancer patients. Further research could be directed towards synergistic effects of multimodal applied NPIs. TRIAL REGISTRATION: Trial registration number DRKS00013335 on 27/11/2017 retrospectively registered.

Evaluation of the effects of integrative non-pharmacological interventions on the internal coherence and resilience of breast cancer patients.

PURPOSE: In the breast cancer center at the Gemeinschaftskrankenhaus Havelhöhe (GKH), integrative strategies are implemented in the routine care of breast cancer patients. The aim of this breast cancer real-world study was to systematically evaluate changes in patients' internal coherence and resilience, associated with the use of non-pharmacological interventions (NPIs). METHODS: This study included 231 primary breast cancer patients treated with standard oncological therapy and NPIs, which comprise art and movement therapies, nursing interventions, and educational components, and had answered the internal coherence scale (ICS) questionnaire at first diagnosis and 12 months later. Data were collected from the Network Oncology clinical registry of the GKH, and effects of NPIs on ICS changes were analyzed with adjusted linear multivariable regression analyses, using the software R. RESULTS: Two hundred twenty breast cancer patients of all tumor stages were eligible for a total of 27 separate adjusted multivariable linear regression analyses. The NPIs elaborate consultations and life review (ECLR); nursing compresses, music therapy, and rhythmic massages were significantly associated with increases of about 2-point changes in inner resilience and coherence (p < 0.05). Furthermore, a significant association with an elevation of the thermo coherence was observed for the application of nursing compresses. CONCLUSIONS: The evaluation of real-world data carried out here shows that the application of the multimodal treatment concept can lead to an enhancement of the internal coherence and resilience in breast cancer patients. To improve the care of cancer patients, this multimodal program should be further expanded into routine clinical practices. TRIAL REGISTRATION: Trial registration number DRKS00013335 on 27/11/2017 retrospectively registered.

Analysis of Changes in Cancer-Related Fatigue of Breast Cancer Patients Receiving an Integrative Medicine Program.

INTRODUCTION: Cancer-related fatigue (CRF) occurs frequently in breast cancer patients. The aim of this real-world study was to analyze the longitudinal changes of CRF in breast cancer patients receiving an integrative medicine program, which includes the application of non-pharmacological interventions (NPIs) and Viscum album L. (VA) extracts. METHODS: All data were collected from the clinical register of the Network Oncology of a German certified breast cancer center of the Gemeinschaftskrankenhaus Havelhöhe (GKH). Primary breast cancer patients, treated upon initial diagnosis with integrated NPIs, comprising art and exercise therapy, nursing interventions, and educational components, during their hospital stay, and who had answered the German Cancer-Fatigue Scale (CFS-D) questionnaire at first diagnosis and 12 months later, were included. The associations between NPIs and CFS-D changes were analyzed with adjusted multivariable regression analyses, considering received treatment regimens and demographic variables, using the software R. RESULTS: 231 female breast cancer patients of all tumor stages were evaluated. While chemotherapy exhibited significant severe deterioration, add-on VA applications seem to partially mitigate this impairment on CRF. 36 separate multivariable regression analyses for all NPIs showed that in particular significant associations between CFS-D improvements and the interventions nursing compresses (6 point change; P = .0002; R² = 28%) or elaborate consultations and life review (ECLR) (4 point change; P = .0002; R² = 25%) were observed. CONCLUSIONS: Breast cancer patients benefit from a hospital-based integrative medicine program. To alleviate fatigue symptoms during oncological therapy, an expansion of this concept should be developed in the future.

Overall Survival of Nonmetastasized NSCLC Patients Treated With Add-On Viscum album L: A Multicenter Real-World Study.

BACKGROUND: Recent data suggest a beneficial effect of add-on treatment with Viscum album L (VA) on the survival in cancer patients. The objective of this study was to compare the impact of standard oncological therapy plus add-on VA treatment (S+VA) versus standard oncological therapy alone (S) on the overall survival (OS) of patients with nonmetastasized non-small cell lung carcinoma (NSCLC). METHODS: The multicenter real-world data study was conducted using data from the Network Oncology Clinical Registry. The primary end point was OS. OS and impact on hazard in both treatment groups were compared. RESULTS: A total of 275 patients with stages I to IIIA NSCLC were enrolled (mean age = 67.6 years, 57.2% male patients). No significant difference of OS was observed between both groups. Even though not significant, for a subgroup of unresected patients with stage I NSCLC, adenocarcinoma or squamous cell carcinoma, a medium effect size OS improvement was observed for S+VA compared to S. CONCLUSIONS: Our findings support the importance of surgery as the most effective intervention in nonmetastasized NSCLC patients. Add-on VA therapy shows here no additional effect in resected patients. However, a small subgroup analysis suggests a possible role of add-on VA for nonresected subgroups. Our results complement existing knowledge on the clinical impact of add-on VA therapy in NSCLC patients and may serve as hypothesis-generating data for further examinations in this cohort. Further research could be directed towards the role of combined therapy for nonresected early-stage NSCLC.

Cost-effectiveness of real-world administration of chemotherapy and add-on Viscum album L. therapy compared to chemotherapy in the treatment of stage IV NSCLC patients.

BACKGROUND: For stage IV lung cancer patients receiving add-on Viscum album L. (VA) treatment an improved overall survival was detected. Information regarding cost-effectiveness (CE) for comparisons between chemotherapy (CTx) and CTx plus additive VA in stage IV lung cancer treatment is limited. The present study assessed the costs and cost-effectiveness of CTx plus VA (V) compared to CTx alone (C) for stage IV non-small cell lung cancer (NSCLC) patients treatment in a hospital in Germany. METHODS: In the observational real-world data study, data from the Network Oncology clinical registry were utilized. Enrolled stage IV lung cancer patients received the respective therapy (C or V) in a certified German Cancer Center. Cost and cost-effectiveness analyses from the hospital's perspective were investigated on the basis of overall survival (OS) and routine financial controlling data. In addition, the incremental cost-effectiveness ratio (ICER) was calculated. The primary result of the analysis was tested for robustness in a bootstrap-based sensitivity analysis. RESULTS: 118 patients (C: n = 86, V: n = 32) were included in the analysis, mean age 63.8 years, the proportion of male patients was 55.1%. Adjusted hospital's total mean costs for patients from the C and V group were €16,289, 95%CI: 13,834€-18,744€ (over an adjusted mean OS time of 13.4 months) and €17,992, 95%CI: 13,658-22,326 (over an adjusted mean OS time of 19.1 months), respectively. The costs per additional OS year gained (ICER) with the V-therapy compared to C therapy were €3,586. CONCLUSION: The findings of the present study suggest that the combined use of chemotherapy and VA was clinically effective and comparably cost-effective to chemotherapy alone in our analysed patient sample from the hospital's perspective. Further randomized and prospective cost-effectiveness studies are necessary to complement our findings.