Introduction Tertiary prevention through physical activity and psychosocial support can positively impact patient outcomes, such as physical function and quality of life (QoL). However, more research is required on the effectiveness of strategies designed to increase the uptake of tertiary prevention programmes among cancer patients. Here, we present the protocol for a single-centre, randomised controlled pilot trial testing the preliminary effectiveness of social prescription and virtual patient information in increasing tertiary prevention among cancer patients and support persons (SPs) (ESPRIT “Effectiveness of a social prescription and virtual patient information in increasing tertiary prevention” pilot trial).Methods and analysis Cancer patients attending medical oncology units at a university hospital in southern Germany and their SPs will be randomly allocated as a dyad to group A (social prescription (n=36)), group B (virtual patient information (n=36)) or group C (usual care (n=36)). The hospital is part of a Comprehensive Cancer Centre mainly treating patients living in rural areas. Primary outcomes are the uptake of physical activity, participation in social activities and psychosocial support. Secondary outcomes are overall QoL, knowledge of the health benefits of physical activity and psychosocial support and self-efficacy of patients. The outcomes will be assessed at baseline and after 3, 6 and 12 months of follow-up. Physical activity will be assessed using accelerometers and measured by average steps per day within the last 2 weeks after recruitment and at follow-up visits (3, 6 and 12 months). Cost-effectiveness and the time spent in the consultation, as well as potential implementation barriers and facilitators, will also be explored as part of a mixed-methods hybrid design. All data will be summarised descriptively. Regarding the analysis of primary endpoints, the average number of steps per day, as well as the summary score of the social activity log and self-report on the use of psychosocial support, will be compared between the groups (A, B and C) using analysis of variance, followed by Dunnett’s test for pairwise comparisons of the intervention groups against the control group. Mean differences and 95% CIs will be presented as effect estimates. The analysis of secondary endpoints will include appropriate statistical methods such as the χ2 test of independence or linear regression models, which will be used to analyse secondary endpoints and to investigate factors influencing preliminary effectiveness.Ethics and dissemination This trial has been approved by the ethics committee of the University of Regensburg (reference: 23-3317-101). Signed written informed consent is required from all study participants. The results of the study will be used to inform the power calculation for future confirmatory trials and will be submitted for publication.Trial registration number DRKS00033771.
ABSTRACTPurposeOffering equal Patient Access to Precision Oncology (PO) is a major challenge of clinical oncologists and cancer center representatives. Here, we provide an easily transferable model adopted from strategic management science to assess the geographic impact of a cancer center – in terms of general cancer care and PO participation.MethodsAs members of the German WERA alliance, the cancer centers Würzburg, Erlangen, Regensburg and Augsburg merged care data regarding their geographical impact. Specifically, we examined the provenance of patients from WERA’s molecular tumor boards (MTBs) between 2020 and 2022 (n = 2243). As second dimension, we added the provenance of patients receiving general cancer care (termed Total Cancer Care, TCC) by WERA. Clustering our outreach along these two dimensions allowed us to set up a four-quadrant matrix consisting of postal code areas with referrals towards WERA. These areas were re-identified on a map of the Federal State of Bavaria and surrounding regions.ResultsIn terms of positive MTB and general cancer care referrals, the WERA Matrix overlooked an active screening area of n = 821 postal code areas – representing about 50% of Bavaria’s spatial expansion and more than six million inhabitants. The WERA Matrix identified regions successfully connected to our outreach structures in terms of subsidiarity – with general cancer care mainly performed locally but PO performed in cooperation with WERA. At the same time, we detected postal code areas with a potential PO backlog – characterized by high levels of cancer care performed by WERA and low levels or no MTB representation.ConclusionsThe WERA Matrix provided a transparent portfolio of postal code areas, which helped assessing the geographical impact of our PO program. We believe that its intuitive principle can easily be transferred to other cancer centers.
PURPOSE:The evaluation of treatment success and progression in oncology patient-reported outcomes (PROs) is playing an increasingly important role. Meanwhile, PROs are a component of the certification requirements of the German Cancer Society for oncology centers. PROs are used to provide supportive therapy. There is currently no instrument that fully covers the requirements. At the University Hospital Regensburg (UKR), a digital ONCOlogical-ROUTinE-Screening (ONCO-ROUTES) procedure was developed in order to assess the need for supportive therapy in a standardized way and to provide patients with supportive interventions tailored to their needs. METHODS:On the basis of current requirements and guidelines, the development of ONCO-ROUTES was supported by experts in focus groups and interviews, and digitalization was carried out in connection with the IT infrastructure. RESULTS:A Needs-based, Quality-of-life (QoL) and Symptoms Screening (NQS2) tool already established in the routine at the UKR was further developed into ONCO-ROUTES, which is made up of the domains therapy phase, nutrition, tobacco use, alcohol use, quality of life, general condition/functional status, physical activity, psychooncology, social services, and further support needs. By linking the digitized questionnaire to the hospital information system, the results are available for immediate use in routine operations and thus for the referral of patients for further supportive therapy. CONCLUSION:The digital PRO application ONCO-ROUTES is designed to involve patients in monitoring additional supportive needs and thus, improves supportive interdisciplinary treatment.
Patient-Reported Outcomes (PRO) spielen in der Onkologie eine zunehmende Rolle bei der Bewertung des Therapieerfolgs und -verlaufs. PRO haben dadurch auch Einzug in die Zertifizierungsanforderungen der Deutschen Krebsgesellschaft für onkologische Zentren gefunden, unter anderem in Bezug auf die Zuführung unterstützender Maßnahmen. Am Universitätsklinikum Regensburg (UKR) wurde ein digitales onkologisches Routinescreening (ONCO-ROUTES) entwickelt, um den Bedarf an unterstützenden Maßnahmen standardisiert zu erfassen und den Patient*innen bedürfnisadaptiert unterstützende Maßnahmen anzubieten. Auf der Basis bereits etablierter Prozesse und aktuell geltender Anforderungen erfolgte die Entwicklung und Digitalisierung in Anbindung an die informationstechnische (IT) Infrastruktur von ONCO-ROUTES mittels Unterstützung durch Expert*innen in Fokusgruppen und Interviews. Ein bereits in der Routine etablierter Lebensqualitäts- und Bedürfnisfragebogen am UKR wurde zu ONCO-ROUTES weiterentwickelt, das sich aus den Bereichen Therapiephase, Ernährung, Tabakkonsum, Alkoholkonsum, Lebensqualität, Allgemeinzustand/Funktionsstatus, körperliche Aktivität, Psychoonkologie, Sozialdienst und weiterer Unterstützungsbedarf zusammensetzt. Durch die Vernetzung des digitalisierten Fragebogens mit dem Krankenhausinformationssystem stehen die Ergebnisse für die unmittelbare Verwendung im Routinebetrieb und somit zur Vermittlung der Patient*innen zu weiteren unterstützenden Maßnahmen zur Verfügung. Durch digitale PRO erschließt sich eine Vielzahl klinischer Anwendungsmöglichkeiten im Kontext onkologischer Zentren. Durch ONCO-ROUTES sollen Patient*innen interdisziplinär mit bedürfnisadaptiert ausgewählten Maßnahmen unterstützend behandelt werden.
Background Recently, molecular tumour boards (MTBs) have been integrated into the clinical routine. Since their benefit remains debated, we assessed MTB outcomes in the Comprehensive Cancer Center Ostbayern (CCCO) from 2019 to 2021. Methods and results In total, 251 patients were included. Targeted sequencing was performed with PCR MSI-evaluation and immunohistochemistry for PD-L1, Her2, and mismatch repair enzymes. 125 treatment recommendations were given (49.8%). High-recommendation rates were achieved for intrahepatic cholangiocarcinoma (20/30, 66.7%) and gastric adenocarcinoma (10/16, 62.5%) as opposed to colorectal cancer (9/36, 25.0%) and pancreatic cancer (3/18, 16.7%). MTB therapies were administered in 47 (18.7%) patients, while 53 (21.1%) received alternative treatment regimens. Thus 37.6% of recommended MTB therapies were implemented (47/125 recommendations). The clinical benefit rate (complete + partial + mixed response + stable disease) was 50.0% for MTB and 63.8% for alternative treatments. PFS2/1 ratios were 34.6% and 16.1%, respectively. Significantly improved PFS could be achieved for m1A-tier-evidence-based MTB therapies (median 6.30 months) compared to alternative treatments (median 2.83 months; P = 0.0278). Conclusion The CCCO MTB yielded a considerable recommendation rate, particularly in cholangiocarcinoma patients. The discrepancy between the low-recommendation rates in colorectal and pancreatic cancer suggests the necessity of a weighted prioritisation of entities. High-tier recommendations should be implemented predominantly.
ABSTRACT Background Molecular Tumor Boards (MTBs) are crucial instruments for discussing and allocating targeted therapies to suitable cancer patients based on genetic findings. Currently, limited evidence is available regarding the regional impact and the outreach component of MTBs. Methods We analyzed MTB patient data from four neighboring Bavarian tertiary care oncology centers in Würzburg, Erlangen, Regensburg, and Augsburg, together constituting the WERA Alliance. Absolute patient numbers and regional distribution across the WERA-wide catchment area were weighted with local population densities. Results Highest MTB patient numbers were found close to the four cancer centers. However, peaks in absolute patient numbers were also detected in more distant and rural areas. Moreover, weighting absolute numbers with local population density allowed us to identify regions within our catchment area relatively underrepresented in WERA MTBs. Conclusion Investigating patient data from four neighboring cancer centers, we comprehensively assessed the regional impact of our MTBs. The results confirmed the success of existing collaborative structures with our regional partners. Additionally, our results help identifying potential white spots in precision oncology and establishing a joint WERA-wide outreach strategy.
(1) Background: molecular tumor boards (MTBs) are crucial instruments for discussing and allocating targeted therapies to suitable cancer patients based on genetic findings. Currently, limited evidence is available regarding the regional impact and the outreach component of MTBs; (2) Methods: we analyzed MTB patient data from four neighboring Bavarian tertiary care oncology centers in Würzburg, Erlangen, Regensburg, and Augsburg, together constituting the WERA Alliance. Absolute patient numbers and regional distribution across the WERA-wide catchment area were weighted with local population densities; (3) Results: the highest MTB patient numbers were found close to the four cancer centers. However, peaks in absolute patient numbers were also detected in more distant and rural areas. Moreover, weighting absolute numbers with local population density allowed for identifying so-called white spots-regions within our catchment that were relatively underrepresented in WERA MTBs; (4) Conclusions: investigating patient data from four neighboring cancer centers, we comprehensively assessed the regional impact of our MTBs. The results confirmed the success of existing collaborative structures with our regional partners. Additionally, our results help identifying potential white spots in providing precision oncology and help establishing a joint WERA-wide outreach strategy.
Non-steroidal anti-inflammatory drugs such as diclofenac exhibit potent anticancer effects. Up to now these effects were mainly attributed to its classical role as COX-inhibitor. Here we show novel COX-independent effects of diclofenac. Diclofenac significantly diminished MYC expression and modulated glucose metabolism resulting in impaired melanoma, leukemia, and carcinoma cell line proliferation in vitro and reduced melanoma growth in vivo. In contrast, the non-selective COX inhibitor aspirin and the COX-2 specific inhibitor NS-398 had no effect on MYC expression and glucose metabolism. Diclofenac significantly decreased glucose transporter 1 (GLUT1), lactate dehydrogenase A (LDHA), and monocarboxylate transporter 1 (MCT1) gene expression in line with a decrease in glucose uptake and lactate secretion. A significant intracellular accumulation of lactate by diclofenac preceded the observed effect on gene expression, suggesting a direct inhibitory effect of diclofenac on lactate efflux. While intracellular lactate accumulation impairs cellular proliferation and gene expression, it does not inhibit MYC expression as evidenced by the lack of MYC regulation by the MCT inhibitor α-cyano-4-hydroxycinnamic acid. Finally, in a cell line with a tetracycline-regulated c-MYC gene, diclofenac decreased proliferation both in the presence and absence of c-MYC. Thus, diclofenac targets tumor cell proliferation via two mechanisms, that is inhibition of MYC and lactate transport. Based on these results, diclofenac holds potential as a clinically applicable MYC and glycolysis inhibitor supporting established tumor therapies.