External applications to reduce cancer-related fatigue in patients with metastatic cancer : a randomized clinical pilot study

Background: Cancer related fatigue (CRF) is a very common concomitant for patients with malig-nant diseases. It limits the person’s quality of life and up until now it is not possible to treat it adequately. External applications have a long tradition within the naturopathic field of medicine. As a part of complementary medicine, they make up a regular com-ponent of therapy concepts. Regarding the usage within the oncology field, especially in the side effect management, there are many positive experiences. Objective: The aim of that study was to examine the impact of the repeated usage of yarrow-liver compresses on the symptoms of TF, quality of life and psychosocial burden of pallia-tive patients with metastatic tumor diseases under radiotherapy (RT). A qualitative analysis of the intervention using self-developed visual analogue scales (VAS) was created as well. Methods: A randomized pilot study was conducted in patients who received inpatient palliative radiation therapy due to metastatic tumor disease and suffered from TF. Patients who were treated for brain or bone metastases with RT during the study period were in-cluded. The subjects from the intervention group were treated daily with the external application for two weeks. At four points in time psychometric data was taken from both groups with the help of standardized questionnaires on fatigue (MFI 20), quality of life (EORTC QLQ C30) and psychosocial stress (NCCN DT) as well as self-developed visual analogue scales (VAS) for the qualitative analysis of the intervention. Results: From September 2017 to August 2019, 39 patients were included in the study. The evaluation consists of collected data from 24 subjects (12 per group). For the primary study endpoint, a clinically relevant improvement in fatigue (subscale „general fatigue” of the MFI 20) in favor of the intervention group was observed. The subscale „reduced motivation” of the MFI 20 shows a significant effect within the intervention group. The evaluation of the QLQ C30 and the DT showed no significant difference in the quality of life and the psychosocial burden. In the VAS a significant improvement for three out of seven symptoms of the intervention group were realized. Conclusions: Within the intervention group noticeable improvements regarding the fatigue as well as the symptoms tension, lack of drive and motivation were noticed. Due to the exami-nation’s pilot character the results must be approved by lager RCT studies in order to be able to give definite statements on the effect of yarrow liver compresses.Hintergrund Tumor-assoziierte Fatigue (TF) ist eine sehr häufige, die Lebensqualität einschränkende und bisher nicht adäquat therapierbare Begleiterscheinung bei Patienten mit malignen Erkrankungen. Äußere Anwendungen haben eine lange Tradition in der naturheilkundlichen Medizin, komplementärmedizinisch sind sie bis heute regelmäßig Bestandteil von Therapiekonzepten. Für die Anwendung im onkologischen Bereich, vor allem im Nebenwirkungsmanagement gibt es positive Erfahrungswerte, es fehlen bisher kontrollierte Studien. Ziel Ziel der Studie war es, die Auswirkung der wiederholten Anwendung von Schafgarbe-Leberkompressen auf die Symptomatik der TF, die Lebensqualität und die psychosoziale Belastung bei palliativen Patient*innen mit metastasierter Tumorerkrankung unter Radiotherapie (RT) zu untersuchen sowie eine qualitative Analyse der Intervention anhand von selbstentwickelten visuellen Analogskalen (VAS) durchzuführen. Methoden Es wurde eine randomisierte Pilotstudie bei Patient*innen durchgeführt, die aufgrund einer metastasierten Tumorerkrankung eine stationäre palliative Bestrahlung erhielten und an TF litten. Es wurden Patient*innen eingeschlossen, die während des Studienzeitraums aufgrund von cerebralen oder ossären Metastasen mit RT behandelt wurden. Die Proband*innen der Interventionsgruppe erhielten über zwei Wochen täglich die äußere Anwendung. Zu vier Zeitpunkten wurden in beiden Gruppen psychometrische Daten mittels standardisierter Fragebögen zur Fatigue (MFI-20), der Lebensqualität (EORTC QLQ-C30) und der psychosozialen Belastung (NCCN DT) sowie selbstentwickelte visu ellen Analogskalen (VAS) zur qualitativen Analyse der Intervention erhoben. Ergebnisse Es wurden zwischen September 2017 und August 2019 39 Patient*innen in die Studie eingeschlossen, in die Auswertung gingen die Daten von 24 Proband*innen (12 pro Gruppe) ein. Für den primären Studienendpunkt konnte eine klinisch relevante Verbesserung der Fatigue (Subskala „allgemeine Fatigue“ des MFI-20) zugunsten der Interventionsgruppe beobachtet werden. In der Subskala „reduzierte Motivation“ des MFI-20 zeigt sich ein signifikanter Effekt in der Interventionsgruppe im Vergleich zur Kontrollgruppe, die drei weiteren Subskalen des MFI-20 tendieren in die gleiche Richtung. In der Auswertung des QLQ-C30 zeigte sich zwischen den beiden Gruppen kein signifikanter Unterschied im globalen Gesundheitszustand bzw. der Lebensqualität. Auch für die psychosoziale Belastung, gemessen anhand des DT, wurden keine eindeutigen Differenzen gemessen. In den VAS konnte für drei von sieben Symptomen eine signifikante Verbesserung bei der Interventionsgruppe beobachtet werden. Zusammenfassung In der Interventionsgruppe konnte eine klinisch relevante Verbesserung der Fatigue und signifikante Besserung der Symptome Anspannung, Antriebslosigkeit und Motivation beobachtet werden. Aufgrund des Pilotcharakters der Untersuchung müssen die Ergebnisse in einer größeren randomisierten Studie bestätigt werden, um eindeutige Aussagen zur Wirkung von Schafgarbe-Leberkompressen treffen zu können

The assessment of mood at workplace - psychometric analyses of the revised Profile of Mood States (POMS) questionnaire

With the Profile of Mood States (POMS), a German version of an international instrument for the assessment of mood is available. The paper introduces a new short version containing 24 items and four scales. In a study about indoor climate in 4596 office workers only a few missing values were noted. Psychometric analyses showed very good characteristics of the four scales regarding their internal consistency (Cronbach’s α) and scale fit. High floor effects indicated a limited exhaustion of the scale range. Age and gender effects of the scale scores concerned the scales “vigour” and “fatigue”. Furthermore, the scales of the POMS discriminated between groups with different self-reported disease incidences. A less beneficial characteristic of the POMS could be noted in terms of a high correlation of the scales “numbness” and “fatigue". With the tested version of the POMS, a short instrument with good psychometric properties has been presented which can be assessed in healthy as well as in health-impaired persons

Randomized Pilot Trial Using External Yarrow Liver Compress Applications With Metastatic Cancer Patients Suffering From Fatigue: Evaluation of Sympathetic Modulation by Heart Rate Variability Analysis

Background: Liver compresses are commonly applied in complementary medicine during cancer treatment and are believed to have an energizing effect. We conducted a pilot study to investigate the influence of external application of yarrow liver compresses on the autonomous nervous system by analyzing the heart rate variability (HRV) in metastatic cancer patients undergoing radiation therapy and suffering from cancer-related fatigue (CRF). Methods: A randomized pilot trial was undertaken with patients suffering from CRF receiving palliative radiation therapy for bone or brain metastasis over 2 weeks. CRF patients were randomized into an intervention group receiving yarrow liver compresses and a control group receiving no external application. HRV was analyzed at the beginning (T1) and end (T2) period of the study during daytime (d) and nighttime (n) in both groups and quantified using time-, frequency-, and nonlinear dynamics domains. Results: A total of 39 patients were randomized between September 2017 and August 2019 and a total of 20 patients (10 per group) were available for analysis. For both groups, significant differences in HRV analyses were found in the comparison over the timeline between the first and second measurement (T1d → T2d) during daytime. Specifically, the intervention group showed decreased HRV and complexity of heart rate regulation, indicating increased sympathetic activity at time T2d, whereas the control group showed increased HRV and complexity of heart rate regulation, indicating increased vagal activity at time T2d. Furthermore, the observed HRV analyses showed almost no significant differences between the 2 groups in a direct comparison at the beginning and the end of the study (exception: T2d). Conclusions: Yarrow liver compresses led to increased sympathetic activity during daytime in the intervention group, whereas in the control group, which did not receive any external application, increased parasympathetic activity was observed

Association of patient, treatment and disease characteristics with patient-reported outcomes: results of the ECHO registry

Patient-reported outcomes (PROs) in people living with haemophilia A (PLWHA) are often under-reported. Investigating PROs from a single study with a diverse population of PLWHA is valuable, irrespective of FVIII product or regimen. To report available data from the Expanding Communications on Haemophilia A Outcomes (ECHO) registry investigating the associations of patient, treatment and disease characteristics with PROs and clinical outcomes in PLWHA. ECHO (NCT02396862), a prospective, multinational, observational registry, enrolled participants aged ≥16 years with moderate or severe haemophilia A using any product or treatment regimen. Data collection, including a variety of PRO questionnaires, was planned at baseline and annually for ≥2 years. Associations between PRO scores and patient, treatment and disease characteristics were determined by statistical analyses. ECHO was terminated early owing to logistical constraints. Baseline data were available from 269 PLWHA from Europe, the United States and Japan. Most participants received prophylactic treatment (76.2%), with those using extended-half-life products (10.0%) reporting higher treatment satisfaction. Older age and body weight >30 kg/m2 (>BMI) were associated with poorer joint health. Older age was associated with poorer physical functioning and work productivity. Health-related quality of life and pain interference also deteriorated with age and >BMI; >BMI also increased pain severity scores. ECHO captured a variety of disease characteristics, treatment patterns, PROs and clinical outcomes obtained in real-world practice with ≤1 year's follow-up. Older age, poorer joint health and >BMI adversely affected multiple aspects of participant well-beingDarwin Healthcare Communications; Baye

BAY 81‐8973 prophylaxis and pharmacokinetics in haemophilia A: Interim results from the TAURUS study

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Cross-Sectional Comparison to Siblings and Peers

Objectives. To investigate self-reported health-related quality of life (HrQoL) in children and adolescents with chronic medical conditions compared with siblings/peers. Methods. Group 1 (6 treatment centers) consisted of 74 children/adolescents aged 8–16 years with hereditary bleeding disorders (HBD), 12 siblings, and 34 peers. Group 2 (one treatment center) consisted of 70 children/adolescents with stroke/transient ischemic attack, 14 siblings, and 72 peers. HrQoL was assessed with the “revised KINDer Lebensqualitätsfragebogen” (KINDL-R) questionnaire. Multivariate analyses within groups were done by one-way ANOVA and post hoc pairwise single comparisons by Student’s -tests. Adjusted pairwise comparisons were done by hierarchical linear regressions with individuals nested within treatment centers (group 1) and by linear regressions (group 2), respectively. Results. No differences were found in multivariate analyses of self-reported HrQoL in group 1, while in group 2 differences occurred in overall wellbeing and all subdimensions. These differences were due to differences between patients and peers. After adjusting for age, gender, number of siblings, and treatment center these differences persisted regarding self-worth () and friend-related wellbeing (). Conclusions. In children with HBD, HrQoL was comparable to siblings and peers. In children with stroke/TIA HrQoL was comparable to siblings while peers, independently of relevant confounder, showed better self-worth and friend-related wellbeing

Health-Related Quality of Life in Children and Adolescents with Hereditary Bleeding Disorders and in Children and Adolescents with Stroke: Cross-Sectional Comparison to Siblings and Peers

Objectives. To investigate self-reported health-related quality of life (HrQoL) in children and adolescents with chronic medical conditions compared with siblings/peers. Methods. Group 1 (6 treatment centers) consisted of 74 children/adolescents aged 8-16 years with hereditary bleeding disorders (HBD), 12 siblings, and 34 peers. Group 2 (one treatment center) consisted of 70 children/adolescents with stroke/transient ischemic attack, 14 siblings, and 72 peers. HrQoL was assessed with the "revised KINDer Lebensqualitatsfragebogen" (KINDL-R) questionnaire. Multivariate analyses within groups were done by one-way ANOVA and post hoc pairwise single comparisons by Student's t-tests. Adjusted pairwise comparisons were done by hierarchical linear regressions with individuals nested within treatment centers (group 1) and by linear regressions (group 2), respectively. Results. No differences were found in multivariate analyses of self-reported HrQoL in group 1, while in group 2 differences occurred in overall wellbeing and all subdimensions. These differences were due to differences between patients and peers. After adjusting for age, gender, number of siblings, and treatment center these differences persisted regarding self-worth (p =.0040) and friend-related wellbeing (p <.001). Conclusions. In children with HBD, HrQoL was comparable to siblings and peers. In children with stroke/TIA HrQoL was comparable to siblings while peers, independently of relevant confounder, showed better self-worth and friend-related wellbeing

Health-Related Quality of Life in Children and Adolescents with Hereditary Bleeding Disorders and in Children and Adolescents with Stroke: Cross-Sectional Comparison to Siblings and Peers

Objectives. To investigate self-reported health-related quality of life (HrQoL) in children and adolescents with chronic medical conditions compared with siblings/peers. Methods. Group 1 (6 treatment centers) consisted of 74 children/adolescents aged 8-16 years with hereditary bleeding disorders (HBD), 12 siblings, and 34 peers. Group 2 (one treatment center) consisted of 70 children/adolescents with stroke/transient ischemic attack, 14 siblings, and 72 peers. HrQoL was assessed with the "revised KINDer Lebensqualitatsfragebogen" (KINDL-R) questionnaire. Multivariate analyses within groups were done by one-way ANOVA and post hoc pairwise single comparisons by Student's t-tests. Adjusted pairwise comparisons were done by hierarchical linear regressions with individuals nested within treatment centers (group 1) and by linear regressions (group 2), respectively. Results. No differences were found in multivariate analyses of self-reported HrQoL in group 1, while in group 2 differences occurred in overall wellbeing and all subdimensions. These differences were due to differences between patients and peers. After adjusting for age, gender, number of siblings, and treatment center these differences persisted regarding self-worth (p =.0040) and friend-related wellbeing (p <.001). Conclusions. In children with HBD, HrQoL was comparable to siblings and peers. In children with stroke/TIA HrQoL was comparable to siblings while peers, independently of relevant confounder, showed better self-worth and friend-related wellbeing