App-Controlled Treatment Monitoring and Support for Patients With Head and Neck Cancer Undergoing Radiotherapy: Results From a Prospective Randomized Controlled Trial.

BACKGROUND: Head and neck cancers (HNCs) are very common malignancies, and treatment often requires multimodal approaches, including radiotherapy and chemotherapy. Patients with HNC often display a high symptom burden, both due to the disease itself and the adverse effects of the multimodal therapy. Close telemonitoring of symptoms and quality of life during the course of treatment may help to identify those patients requiring early medical support. OBJECTIVE: The App-Controlled Treatment Monitoring and Support for Patients With Head and Neck Cancer (APCOT) trial aimed to investigate the feasibility of integrating electronic patient-reported outcomes (ePROs) in the treatment surveillance pathway of patients with HNC during the course of their radiotherapy. Additionally, the influence of app-based ePRO monitoring on global and disease-specific quality of life and patient satisfaction with treatment was assessed. METHODS: Patients undergoing radiotherapy for histologically proven HNCs at the Department of Radiation Oncology, University Medical Center Freiburg, Germany, were enrolled in this trial and monitored by weekly physician appointments. Patients were randomized between additional ePRO monitoring on each treatment day or standard-of-care monitoring. Feasibility of ePRO monitoring was defined as ≥80% of enrolled patients answering ≥80% of their daily app-based questions. Quality of life and patient satisfaction were assessed by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30), the head and neck cancer module (H&N35), and the validated Patient Satisfaction Questionnaire Short Form (PSQ-18) at the completion of treatment and compared between trial arms. RESULTS: A total of 100 patients were enrolled in this trial, and 93 patients were evaluable. All patients (100%) in the experimental arm answered ≥80% of the ePRO questions during treatment, reaching the predefined threshold for the feasibility of ePRO monitoring (P<.001 in the binomial test). No clinical or patient-specific factor was found to influence feasibility. Global health and most domains of the general quality of life were comparable between trial arms, but an increased HNC-specific symptom burden was reported by patients undergoing ePRO surveillance. ePRO monitoring resulted in improved patient satisfaction regarding interpersonal manners (P=.01), financial aspects (P=.01), and time spent with a doctor (P=.01). CONCLUSIONS: This trial demonstrated the feasibility of incorporating daily app-based ePRO surveillance for patients with HNC undergoing radiotherapy. Our data, for the first time, demonstrate that telemonitoring in this setting led to increased reporting of HNC-specific symptom burden and significantly improved several domains of patient satisfaction. Further analyses are needed to assess whether our findings hold true outside the context of a clinical trial. TRIAL REGISTRATION: German Clinical Trials Register DRKS00020491; https://drks.de/search/en/trial/DRKS00020491.

Ventricular fibrillation and Takotsubo cardiomyopathy triggered by media panic on COVID-19: A case report.

Takotsubo cardiomyopathy has potentially lethal complications and can be caused by a media-induced diffuse atmosphere of life threatening and panic in preconditioned patients.

App-Controlled Treatment Monitoring and Support for Head and Neck Cancer Patients (APCOT): Protocol for a Prospective Randomized Controlled Trial.

BACKGROUND: Head and neck cancers (HNCs) are among the most common malignancies, which often require multimodal treatment that includes radiation therapy and chemotherapy. Patients with HNC have a high burden of symptoms due to both the damaging effects of the tumor and the aggressive multimodal treatment. Close symptom monitoring over the course of the disease may help to identify patients in need of medical interventions. OBJECTIVE: This APCOT (App-Controlled Treatment Monitoring and Support for Head and Neck Cancer Patients) trial is designed to assess the feasibility of monitoring HNC patients during the course of (chemo)radiation therapy daily using a mobile app. Additionally, symptom patterns, patient satisfaction, and quality of life will be measured in app-monitored patients in comparison to a patient cohort receiving standard-of-care physician appointments, and health economy aspects of app monitoring will be analyzed. METHODS: This prospective randomized single-center trial will evaluate the feasibility of integrating electronic patient-reported outcome measures (ePROMs) into the treatment workflow of HNC patients. Patients undergoing definitive or adjuvant (chemo)radiation therapy as part of their HNC treatment at the Department of Radiation Oncology, University Medical Center Freiburg (Freiburg, Germany) will receive weekly physician appointments and additional appointments as requested to monitor and potentially treat symptoms during the course of treatment. Patients in the experimental arm will additionally be monitored daily using a dedicated app regarding their disease- and treatment-related symptoms, quality of life, and need for personal physician appointments. The feasibility of ePROM monitoring will be tested as the primary endpoint and will be defined if ≥80% of enrolled patients have answered ≥80% of their daily app-based questions. Quality of life will be assessed using the validated European Organisation for Research and Treatment of Cancer questionnaires, and patient satisfaction will be measured by the validated Patient Satisfaction Questionnaire Short Form at the initiation, in the middle, and at completion of radiation therapy, as well as at follow-up examinations. Additionally, the number and duration of physician appointments during the course of radiation therapy will be quantified for both ePROM-monitored and standard-of-care patients. RESULTS: This trial will enroll 100 patients who will be randomized (1:1) between the experimental arm with ePROM monitoring and the control arm with standard patient care. Recruitment will take 18 months, and trial completion is planned at 24 months after enrollment of the last patient. CONCLUSIONS: This trial will establish the feasibility of close ePROM monitoring of HNC patients undergoing (chemo)radiation therapy. The results can form the basis for further trials investigating potential clinical benefits of detailed symptom monitoring and patient-centered care in HNC patients regarding oncologic outcomes and quality of life. TRIAL REGISTRATION: German Clinical Trials Register DRKS00020491; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00020491. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/21693.

Digital Follow-Up and the Perspective of Patient-Centered Care in Oncology: What's the PROblem?

There is accumulating evidence from randomized trials suggesting that digital patient-centered care allows a more reliable detection of tumour-related symptoms and adverse events - with a direct impact on overall survival. Consequently, a variety of unsynchronized approaches were kicked off to (electronically) measure patient-reported outcomes (PROs). Despite increasing evidence that PRO data are highly relevant for patient care, the data generated in these initial projects lack standardized processing pathways in order to impact clinical routine; therefore, potential future routine PRO assessments require adequate analysis, storage and processing to allow a robust, reproducible and reliable incorporation into routine clinical decision-making. Here, we discuss relevant challenges of digital follow-up that need to be tackled to render PRO data as relevant to physicians as laboratory or biomarker data.

Visualization of data in radiotherapy using web services for optimization of workflow.

BACKGROUND: Every day a large amount of data is produced within a radiotherapy department. Although this data is available in one form or other within the centralised systems, it is often not in the form which is of interest to the departmental staff. This work presents a flexible browser based reporting and visualization system for clinical and scientific use, not currently found in commercially available software such as MOSAIQ(TM) or ARIA(TM). Moreover, the majority of user merely wish to retrieve data and not record and/or modify data. Thus the idea was conceived, to present the user with all relevant information in a simple and effective manner in the form of web-services. Due to the widespread availability of the internet, most people can master the use of a web-browser. Ultimately the aim is to optimize clinical procedures, enhance transparency and improve revenue. METHODS: Our working group (BAS) examined many internal procedures, to find out whether relevant information suitable for our purposes lay therein. After the results were collated, it was necessary to select an effective software platform. After a more detailed analysis of all data, it became clear that the implementation of web-services was appropriate. In our institute several such web-based information services had already been developed over the last few years, with which we gained invaluable experience. Moreover, we strived for high acceptance amongst staff members. RESULTS: By employing web-services, we attained high effectiveness, transparency and efficient information processing for the user. Furthermore, we achieved an almost maintenance-free and low support system. The aim of the project, making web-based information available to the user from the departmental system MOSAIQ, physician letter system MEDATEC(R) and the central finding server MiraPlus (laboratory, pathology and radiology) were implemented without restrictions. CONCLUSION: Due to widespread use of web-based technology the training effort was effectively nil, since practically every member of staff can master the use of a web-browser. Moreover, we have achieved high acceptance amongst staff members and have improved our effectiveness resulting in a considerable time saving. The many MOSAIQ-specific parts of the system can be readily used by departments which use MOSAIQ as the departmental system.

[Survey of potential improvements during the course of the radiotherapy treatment--a patient questionnaire]. / Erfassung möglicher Verbesserungen im Ablauf der Strahlentherapie--eine Patientenbefragung.

INTRODUCTION AND BACKGROUND: In the context of quality assurance, increasing demands are placed on the whole radiotherapy treatment process. The patients directly concerned generally do not realize most aspects of the quality assurance program (e.g., additional safety checks) during their daily therapy. It was the aim of this study to systematically ask patients about potential improvements during the course of radiotherapy treatment from their own perspective. PATIENTS AND METHODS: In the defined time span (1 month), 624 radiotherapy patients (600 questionnaires were returned, 96.2%) were interviewed using a questionnaire newly developed to inquire about several aspects of their treatment. Furthermore, they were asked for their specific needs and suggestions for improvements that could be made during the course of radiotherapy treatment. RESULTS: Overall, the patients were satisfied with the course of their radiotherapy treatment and with patient care. As an example, about 90% agreed with the statement: "My first contact with the radiation oncology unit proceeded with kindness and competence so that I was given the impression that I will be well cared for in this clinic." Considering the organization of the course of radiotherapy, a large majority of patients attached great value to set appointments for the therapy fractions. A main point of criticism was waiting times or delays caused by servicing or machine failures. Small, low cost improvements as music in the therapy room were considered as important as expensive measures (e.g., daylight in the therapy room). The patients emphasized the importance of staff friendliness. CONCLUSION: The situation of radiotherapy patients was, in general, satisfactory. Future improvements can be mainly expected from smooth organisation of both planning and treatment which can be achieved by electronic scheduling systems. Many results of the survey could be easily implemented in daily practice. In matters of organization radiation oncology with its complex procedures can be used as a model for other clinical departments.

An interindividual comparison of O-(2-[18F]fluoroethyl)-L-tyrosine (FET)- and L-[methyl-11C]methionine (MET)-PET in patients with brain gliomas and metastases.

PURPOSE: L-[methyl-(11)C]methionine (MET)-positron emission tomography (PET) has a high sensitivity and specificity for imaging of gliomas and metastatic brain tumors. The short half-life of (11)C (20 minutes) limits the use of MET-PET to institutions with onsite cyclotron. O-(2-[(18)F]fluoroethyl)-L-tyrosine (FET) is labeled with (18)F (half-life, 120 minutes) and could be used much more broadly. This study compares the uptake of FET and MET in gliomas and metastases, as well as treatment-induced changes. Furthermore, it evaluates the gross tumor volume (GTV) of gliomas defined on PET and magnetic resonance imaging (MRI). METHODS AND MATERIALS: We examined 42 patients with pretreated gliomas (29 patients) or brain metastases (13 patients) prospectively by FET- and MET-PET on the same day. Uptake of FET and MET was quantified by standardized uptake values. Imaging contrast was assessed by calculating lesion-to-gray matter ratios. Tumor extension was quantified by contouring GTV in 17 patients with brain gliomas. Gross tumor volume on PET was compared with GTV on MRI. Sensitivity and specificity of MET- and FET-PET for differentiation of viable tumor from benign changes were evaluated by comparing the PET result with histology or clinical follow-up. RESULTS: There was a strong linear correlation between standardized uptake values calculated for both tracers in cortex and lesions: r = 0.78 (p = 0.001) and r = 0.84 (p < 0.001), respectively. Image contrast was similar for MET- and FET-PET (lesion-to-gray matter ratios of 2.36 ± 1.01 and 2.33 ± 0.77, respectively). Mean GTV in 17 glioma patients was not significantly different on MET- and FET-PET. Both MET- and FET-PET delineated tumor tissue outside of MRI changes. Both tracers provided differentiated tumor tissue and treatment-related changes with a sensitivity of 91% at a specificity of 100%. CONCLUSIONS: O-(2-[(18)F]fluoroethyl)-L-tyrosine-PET and MET-PET provide comparable diagnostic information on gliomas and brain metastases. Like MET-PET, FET-PET can be used for differentiation of residual or recurrent tumor from treatment-related changes/pseudoprogression, as well as for delineation of gliomas.

[Automated delivery of codes for charge in radiotherapy]. / Automatisierte Leistungsübermittlung in der Strahlenheilkunde.

BACKGROUND AND PURPOSE: For the medical billing of Radiotherapy every fraction has to be encoded, including date and time of all administered treatments. With fractions averaging 30 per patient and about 2,500 new patients every year the number of Radiotherapy codes reaches an amount of 70,000 and more. Therefore, an automated proceeding for transferring and processing therapy codes has been developed at the Department of Radiotherapy Freiburg, Germany. This is a joint project of the Department of Radiotherapy, the Administration Department, and the Central IT Department of the University Hospital of Freiburg. MATERIAL AND METHODS: The project consists of several modules whose collaboration makes the projected automated transfer of treatment codes possible. The first step is to extract the data from the department's Clinical Information System (MOSAIQ). These data are transmitted to the Central IT Department via an HL7 interface, where a check for corresponding hospitalization data is performed. In the further processing of the data, a matching table plays an important role allowing the transformation of a treatment code into a valid medical billing code. In a last step, the data are transferred to the medical billing system. RESULTS AND CONCLUSION: After assembling and implementing the particular modules successfully, a first beta test was launched. In order to test the modules separately as well as the interaction of the components, extensive tests were performed during March 2006. Soon it became clear that the tested procedure worked efficiently and accurately. In April 2006, a pilot project with a few qualities of treatment (e.g., computed tomography, simulation) was put into practice. Since October 2006, nearly all Radiation Therapy codes (approximately 75,000) are being transferred to the comprehensive Hospital Information System (HIS) automatically in a daily routine.

Molecular radiobiology meets clinical radiation oncology.

BACKGROUND: The 2nd Langendorff Congress in Freiburg in Breisgau (Germany) gathered basic and translational scientists as well as clinicians interested in recent developments in molecular and clinical radiobiology. The topics ranged from the most recent insight into the organisation of the DNA damage response and radiotherapeutically relevant cell death mechanisms to biological imaging for treatment planning and advances in the understanding of the molecular biological effects of particle beams. Clinical aspects of stem cell and tumour stem cell biology as well as of angiogenesis and hypoxia, the search for novel molecular radiosensitisers and potential strategies for exploitation of the immune system to further improve tumour radiotherapy were also discussed. RESULTS AND CONCLUSION: This report surveys the presentations at the meeting, considering their significance in light of the literature, and documents the increasing importance of molecular radiobiology for clinical radiooncology.

[Department and patient management in radiotherapy. The Freiburg model]. / Abteilungs- und Patientenmanagement in der Strahlenheilkunde. Das Freiburger Modell.

BACKGROUND AND PURPOSE: The activities in radiotherapy are mainly affected by numerous partly very complex operational procedures which have to be completed while high safety requirements have to be fulfilled. This fact and steadily increasing economic pressure are forcing us to develop new strategies which help us to optimize our operational procedures and assure their reliability. As there are not so many radiotherapeutic institutions and the main focus, up to now, was mainly stressed on the acceleration systems (radiation planning, acceleration control), only few industrial systems are available which could also support the economic, organizational and administrative needs of radiotherapy. METHODS: During the building operations for the "new clinic for radiotherapy" at the University Hospital Freiburg, Germany, the staff of the clinical and administrative information and the medical physicists developed, in close cooperation with the physicians, a comprehensive concept to control and organize a radiotherapeutic institution. This concept was examined during the construction phase of the new clinic and the adjoined HBFG ("Hochschulbauförderungsgesetz") process by the "Deutsche Forschungsgemeinschaft" and financed totally by federal funds. RESULTS AND CONCLUSION: The precondition for the goal to operate a homogeneous and comprehensive management of a clinic for radiotherapy was the direct connection of the acceleration area with the organizational/administrative surrounding. The thus developed common basic dates and consistence created transparency and allowed us for the first time to control all operational procedures by EDV-technical means. After 2 years full-time operation and implementation of numerous particular projects we are now ready for film- and paperless digital work.