Cornelia von Hagens

Resilience in infertile couples acts as a protective factor against infertility-specific distress and impaired quality of life

ObjectiveOur hypothesis was that resilience (=psychosocial stress-resistance) reduces infertility-specific distress and maintains quality of life of infertile couples.MethodsQuestionnaire data of WHO Quality of Life assessment (WHOQOL; domains: ‘physical’, ‘psychological’, ‘social relationships’ and ‘environment’), Fertility Problem Inventory (FPI; scales: ‘social concern’, ‘sexual concern’, ‘relationship concern’, ‘rejection of childfree lifestyle’ and ‘need for parenthood’), Resilience Scale (RS), as well as sociographic and medical data were available for 199 infertile couples.ResultsAge, medical diagnosis and ‘intensity of desire for a child’ had no influence on quality of life. High scores on ‘suffering from childlessness’ went along with less satisfaction on ‘physical’ and ‘psychological’ domains for the women only. For both partners, high scores on ‘suffering from childlessness’ went along with higher scores on all FPI scales. High resilience was associated with high scores on all WHOQOL domains for both partners, also with low scores on all FPI scales except for ‘need for parenthood’ for the women and with a low score only on ’relationship concern’ for the men.ConclusionsFor infertile couples, resilience can be considered as an unspecific protective factor against infertility-specific distress and impaired quality of life. When offering counselling to involuntarily childless couples, awareness should be raised for resilience as a couple’s resource and a “generic” factor of coping.

Erratum to: Investigation of ototoxicity of artesunate as add-on therapy in patients with metastatic or locally advanced breast cancer: new audiological results from a prospective, open, uncontrolled, monocentric phase I study

Purpose Artesunate (ART) has been used for a long time in the treatment of Plasmodium falciparum malaria and has been considered safe. The present phase I study aimed to determine the daily dose of ART that is well tolerated as add-on therapy in patients with breast cancer for 4 weeks of therapy. Ototoxicity could be a potential safety concern in settings different from malaria. Therefore, comprehensive audiological assessment was essential.

Developing and implementing a complex Complementary and Alternative (CAM) nursing intervention for breast and gynecologic cancer patients undergoing chemotherapy--report from the CONGO (complementary nursing in gynecologic oncology) study.

AbstractPurpose/objectivesThe purpose of this study was to develop a complex nursing intervention including complementary and alternative medicine (CAM) for breast and gynecologic cancer patients during chemotherapy to improve quality of life.MethodsData sources Theoretical framework and concepts, practical nursing knowledge, and evidence-based studies were compiled in interprofessional meetings. Data synthesis The final complex intervention consists of three autonomous, but interacting components: (1) CAM nursing package, (2) resource-oriented counseling, and (3) evidence-based information material on CAM. CAM interventions include acupressure, aromatherapy, compress, and massage, targeting 14 clinically relevant symptoms during chemotherapy. Participants receive these interventions during chemotherapy with instructions for self care. During a counseling interview, the patient’s needs and preferences are assessed by trained nurses. Furthermore, participants are equipped with evidence-based information material (booklet and DVD). Prior to study start, nurses attended training modules for administering CAM therapies and for communicating and counseling within the salutogenic approach.ConclusionsIt was possible to design a multimodal CAM nursing intervention based on a theoretical concept, evidence-based studies, and practical nursing experience targeting the prevention or relief of side-effects women suffer during chemotherapy. The systematic analysis of the CONGO study will contribute to evidence-based CAM nursing care within supportive cancer care.Implications for integrative cancer careOncology nurses play an important role in supportive CAM care of breast and gynecologic cancer patients in daily clinical practice. Within oncology outpatient services, the implementation of evidence-based CAM nursing interventions and counseling may contribute to understand the impact of nursing on patient quality of life and symptom relief. This can lead to a new understanding of the nurse’s professional role.

A complex nursing intervention of complementary and alternative medicine (CAM) to increase quality of life in patients with breast and gynecologic cancer undergoing chemotherapy: study protocol for a partially randomized patient preference trial

BackgroundHealth-related quality of life (HRQoL) is most adversely affected in cancer patients between diagnosis and the end of chemotherapy. The aim of the Complementary Nursing in Gynecologic Oncology (CONGO) study is to assess the effectiveness of a complex nursing care intervention of CAM to increase HRQoL in cancer patients undergoing chemotherapy.Methods/designCONGO is a prospective partially randomized patient preference (PRPP) trial including adult women diagnosed with breast and gynecologic cancer starting a new chemotherapy regimen. Patients without strong preferences for CAM will be randomized to usual nursing care or complex nursing care; those patients with strong preferences will be allowed their choice. The intervention consists of three interacting and intertwined elements: CAM nursing intervention packet, counseling on CAM using a resource-oriented approach and evidence-based informational material on CAM.Primary outcome data on participants’ HRQoL will be collected from baseline until the end of treatment and long-term follow-up using the EORTC-QLQ-C30. Secondary outcomes include nausea, fatigue, pain, anxiety/depression, social support, self-efficacy, patient competence, spiritual wellbeing, and satisfaction with care. Accompanying research on economic outcomes as well as a mixed-methods process evaluation will be conducted.A total of 590 patients (236 patients in the randomized part of the study and 354 patients in the observational part of the study) will be recruited in the two outpatient clinics. The first analysis step will be the intention-to-treat (ITT) analysis of the randomized part of the trial. A linear mixed model will be used to compare the continuous primary endpoint between the intervention and control arm of the randomized group. The observational part of the trial will be analyzed descriptively. External validity will be assessed by comparing randomized with nonrandomized patients.DiscussionCancer patients are increasingly using CAM as supportive cancer care, however, a patient-centered model of care that includes CAM for the patient during chemotherapy still needs to be evaluated. This protocol has been designed to test if the effects of the intervention go beyond potential benefits in quality-of-life outcomes.Trial registrationGerman Clinical Trials Register (DRKS), DRKS00006056 (15 April 2014).

A high-throughput LC-MS/MS assay for quantification of artesunate and its metabolite dihydroartemisinin in human plasma and saliva.

AIM Saliva is an alternative sampling matrix to plasma, offering a noninvasive technique, but requires a highly sensitive bioanalytical method. MATERIALS & METHODS An API 3000 triple quadrupole mass spectrometer with an electrospray ionization source operated in the positive ion mode was used for the analysis. RESULTS A high-throughput LC-MS/MS method using SPE for the quantification of artesunate and dihydroartemisinin in plasma and saliva has been optimized and validated according to US FDA guidelines. For both analytes the LLOQ was determined to 5 ng/ml and the calibration range was 5-1000 ng/ml for artesunate and 5-2000 ng/ml for dihydroartemisinin. CONCLUSION For the first time, a bioanalytical method for determination of artesunate and dihydroartemisinin in human saliva has been described, showing possible applicability in clinical saliva samples in addition to plasma samples.

Alternative Therapiemöglichkeiten im Klimakterium

Fragestellung: İbersicht über alternative Therapiemöglichkeiten im Klimakterium. Methoden: Literaturrecherche in Cochrane Library und Medline (1966–2006) nach Stichwörtern, zu naturheilkundlicher Intervention im Klimakterium und in Originalarbeiten oder Reviews, die zusätzlich gefunden wurden. Ergebnisse: Die Gesamtdaten zeigen, dass Cimicifuga, eventuell auch Phytoöstrogene, Hopfen und Salbei klimakterische Beschwerden, insbesondere Hitzewallungen, beeinflussen können. Johanniskraut kann moderate depressive Verstimmungen lindern. Für Phytoöstrogene gibt es Hinweise zur Knochenprotektion und Risikoreduktion von Herzerkrankungen. Zum Einfluss des Lebensstils auf Hitzewallungen gibt es keine eindeutigen Aussagen, Studien belegen eine präventive Wirksamkeit auf Knochen und Herz/Kreislauf. Schlussfolgerung: Lebensstil, Cimicifuga und Phytoöstrogene sind eine Option zur Linderung von Wechseljahresbeschwerden und Prävention chronischer Alterserkrankungen. Phytoöstrogene und Cimicifuga können bei Brustkrebspatientinnen nicht empfohlen werden.

How the Consolidated Framework for Implementation Research Can Strengthen Findings and Improve Translation of Research Into Practice: A Case Study

PURPOSE/OBJECTIVES To answer how the planned intervention was performed in routine care, which factors supported or distracted from its implementation, and how key organizational structures have been built and sustained.
. RESEARCH APPROACH Mixed-methods process evaluation.
. SETTING Two German outpatient cancer clinics.
. PARTICIPANTS Purposive sampling of 297 recruited patients with gynecologic cancer, their treating oncology nurses, and their interprofessional healthcare team, and the clinical stakeholders of two different outpatient cancer clinics.
. METHODOLOGIC APPROACH Guided by the Consolidated Framework for Implementation Research (CFIR), five distinct interrelated substudies were designed to evaluate intervention characteristics, inner and outer settings, characteristics of the individuals involved, and the process of implementation. Quantitative and qualitative data will be analyzed separately and then integrated into a framework analysis.
. FINDINGS Oncology nurses found the regular process analytic sessions to be beneficial, not only for sharing their experience, but also for experiencing social support and social connectedness.
. INTERPRETATION Key implementation facets of the nurse-led intervention will be examined systematically. The results can guide future implementation processes, which need to be tailored to interested facilities.
. IMPLICATIONS FOR NURSING The CFIR framework is well established but not yet widely applied in supportive treatment research. The current study aims to apply and combine this framework with the concept of intervention fidelity.

Long-term add-on therapy (compassionate use) with oral artesunate in patients with metastatic breast cancer after participating in a phase I study (ARTIC M33/2)

BACKGROUND The antimalarial artesunate (ART), a semisynthetic derivative of artemisinin from the Chinese herb artemisia annua has remarkable anticancer properties in vitro and in vivo. Its excellent safety profile known from short-term therapy in malaria was confirmed in an open phase I trial (ARTIC M33/2) for dose-finding as add-on therapy for four weeks. PURPOSE Patients with metastatic breast cancer, who had not experienced any clinically relevant adverse events (AE) during participation in ARTIC M33/2, were offered to continue ART as compassionate use (CU). Regular monitoring was continued in order to ensure adequate individual safety and tolerability and to collect information about long-term treatment with ART. Clinically relevant AEs or second progression of disease during ART were reasons for discontinuation of the add-on therapy. STUDY DESIGN Compassionate use was offered open-label to participants of ARTIC M33/2. METHODS Patients continued to take 100, 150 or 200 mg oral ART daily as add-on therapy to their guideline-based oncological therapy. Clinical and laboratory monitoring included audiological and neurological examination, ECG, NTproBNP and reticulocyte determination. Cumulative treatment days and cumulative ART doses encompass both the phase I study as well as the continued add-on treatment period (CU). RESULTS Following the 4 ± 1 weeks of the phase I trial, thirteen patients continued the add-on therapy as CU, resulting in a total of 3825 treatment days. In individual patients up to 1115 cumulative treatment days (37 months) and cumulative ART doses up to 167.3 g were reached. A total of 25 AEs grade ≥ 2 at least possibly related to ART long-term add-on therapy were documented, two, six and 17 in dose groups 100, 150 and 200 mg/d ART respectively. Six of these AEs were classified as grade 3, two in patients taking 150 and four in patients on 200 mg/d, none of them being probably or certainly related to ART. CONCLUSIONS In thirteen patients with metastatic breast cancer up to 200 mg/d long-term oral ART (2.3-4.1 mg/kg BW/d) in up to 1115 cumulative treatment days (37 months) did not result in any major safety concerns.

Sanfte Alternativen zur Hormonersatztherapie

ZusammenfassungGesunde Ernährung, viel Bewegung und effektives Stressmanagement tragen nicht nur zur Prävention altersassoziierter Erkrankungen bei, sie können auch klimakterische Beschwerden günstig beeinflussen. Zudem liegen mittlerweile Studienergebnisse zur Wirkung von Phytotherapie, Homöopathie, Akupunktur und chinesischer Phytotherapie gegen die typischen Symptome des Klimakteriums vor.