Oncologic treatment support via a dedicated mobile app: a prospective feasibility evaluation (OPTIMISE-1).

BACKGROUND: Mobile health (mhealth) is gaining interest, with mobile devices and apps being ever more available among medical facilities and patients. However, in the field of radiation oncology, the medical benefits of mhealth apps are still underexplored. As an additional approach to patient care during radiotherapy, we designed a mobile treatment surveillance app based on patient-reported outcomes. OBJECTIVE: We aimed to examine the feasibility of app-based treatment surveillance in patients undergoing radiotherapy (RT). Alongside technical practicability and acceptance, we assessed patient satisfaction and quality of life during treatment. METHODS: This prospective single-center study was performed at Heidelberg University Hospital between August 2018 and January 2020. During RT we measured patients' quality of life, symptoms, and treatment satisfaction. Respective questionnaires (EORTC QLQ-C30 with diagnosis-specific modules, RAND PSQ-18) were presented to patients via a mobile app running on a designated tablet device. The primary endpoint was determined by the fraction of patients who completed at least 80% of the items. Secondary endpoints were disease-related quality of life and patient satisfaction. RESULTS: A total of 49 cancer patients (14 breast, 13 pelvic, 12 lung, 10 prostate) were eligible for analysis. 79.6% (95% confidence interval: 66.4-88.5%; n = 39) of all patients completed at least 80% of the items received by the mobile app. A mean of 227.5 ± 48.25 questions were answered per patient. Breast cancer patients showed the highest rate of answered questions, with 92.9% (n = 13) completing at least 80% of the items. CONCLUSION: Patients showed high acceptance, with 79.6% (n = 39) completing at least 80% of the given items. The use of a mobile app for reporting symptoms and quality of life during RT is feasible and well accepted by patients. It may allow for resource-efficient, detailed feedback to the medical staff and assist in the assessment of side effects over time.

Supportive Care in Radiotherapy Based on a Mobile App: Prospective Multicenter Survey.

BACKGROUND: Consumer electronics and Web-enabled mobile devices are playing an increasing role in patient care, and their use in the oncologic sector opens up promising possibilities in the fields of supportive cancer care and systematic patient follow-up. OBJECTIVE: The objective of our study was to assess the acceptance and possible benefits of a mobile app-based concept for supportive care of cancer patients undergoing radiotherapy. METHODS: In total, 975 patients presenting for radiotherapy due to breast or prostate cancer were screened; of them, 200 owned a smartphone and consented to participate in the survey. Patients were requested to complete a questionnaire at 2 time points: prior to the initiation (T0) and after the completion (T1) of radiotherapy. The questionnaire included questions about the habits of smartphone usage, technical knowledge and abilities of the participants, readiness to use a mobile app within the context of radiotherapy, possible features of the mobile app, and general attitude toward the different aspects of oncologic treatments. For quantitative analysis, sum scores were calculated for all areas of interest, and results were correlated with patient characteristics. Additionally, answers were quantitatively compared between time points T0 and T1. RESULTS: Median patient age was 57 (range 27-78) years. Of the 200 participants, 131 (66.2%) reported having the ability to use their smartphones with minimal to no help and 75.8% (150/200) had not used their smartphones in a medical context before. However, 73.3% (146/200) and 83.4% (166/200) of patients showed a strong interest in using a mobile app for supportive care during radiotherapy and as part of the clinical follow-up, respectively. Patients most commonly requested functionalities regarding appointment scheduling in the clinic (176/200, 88.0%) and the collection of patient-reported outcome data regarding their illness, therapy, and general well-being (130/200, 65.0%). Age was identified as the most influential factor regarding patient attitude, with patients aged <55 years being significantly more inclined toward and versed in smartphone use (P<.001). The acceptance of mobile apps was significantly higher in patients exhibiting a Karnofsky performance index <80% (P=.01). Support in the context of therapy-related side effects was judged most important by patients with poor clinical performance (P=.006). The overall acceptance of mobile apps in the context of radiotherapy surveillance was high at a median item sum score of 71.4/100 and was not significantly influenced by tumor stage, age, gender, treatment setting, or previous radiotherapies. CONCLUSIONS: The acceptance of mobile apps for the surveillance and follow-up of cancer patients undergoing radiotherapy is high; this high acceptance level will serve as a basis for future clinical trials investigating the clinical benefits of mobile app-based treatment support. Introduction of mobile apps into the clinical routine should be considered as an opportunity to improve and intensify supportive treatment for cancer patients.

Oncologic Therapy Support Via Means of a Dedicated Mobile App (OPTIMISE-1): Protocol for a Prospective Pilot Trial.

BACKGROUND: The increasing role of consumer electronics and Web-enabled mobile devices in the medical sector opens up promising possibilities for integrating novel technical solutions into therapy and patient support for oncologic illnesses. A recent survey carried out at Heidelberg University Hospital suggested a high acceptance among patients for an additional approach to patient care during radiotherapy based on patient-reported outcomes by a dedicated mobile app. OBJECTIVE: The aim of this trial (OPTIMISE-1: Oncologic Therapy Support Via Means of a Dedicated Mobile App - A Prospective Feasibility Evaluation) is to prospectively evaluate the feasibility of employing a mobile app for the systematic support of radiooncological patients throughout the course of their radiotherapy by monitoring symptoms and patient performance, and facilitating the background-exchange of relevant information between patient and physician. METHODS: The present single-center, prospective, exploratory trial, conducted at Heidelberg University Hospital, assesses the feasibility of integrating an app-based approach into patient-care during radiotherapy. Patients undergoing curative radiotherapy for thoracic or pelvic tumors will be surveyed regarding general performance, treatment-related quality of life (QoL) and symptoms, and their need to personally consult a physician by means of a mobile app during treatment. The primary endpoint of feasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day. Furthermore, treatment-related patient satisfaction and health-related QoL is assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) and the European Organization for Research and Treatment of Cancer (EORTC) questionnaires at the beginning (baseline) and end of radiotherapy, and at the first follow-up. RESULTS: This trial will recruit 50 patients over a period of 12 months. Follow-up will be completed after 18 months, and publication of results is planned at 24 months after trial initiation. CONCLUSIONS: This study will serve as a basis for future studies aiming to exploit the constant innovation in mobile medical appliances and integrate novel patient-centered concepts into patient care in the context of radiotherapy. TRIAL REGISTRATION: ClinicalTrials.gov NCT03168048; https://clinicaltrials.gov/ct2/show/NCT03168048 (Archived at WebCite http://www.webcitation.org/6wtWGgi0X).

Analyzing human decisions in IGRT of head-and-neck cancer patients to teach image registration algorithms what experts know.

BACKGROUND: In IGRT of deformable head-and-neck anatomy, patient setup corrections are derived by rigid registration methods. In practice, experienced radiation therapists often correct the resulting vectors, thus indicating a different prioritization of alignment of local structures. Purpose of this study is to transfer the knowledge experts apply when correcting the automatically generated result (pre-match) to automated registration. METHODS: Datasets of 25 head-and-neck-cancer patients with daily CBCTs and corresponding approved setup correction vectors were analyzed. Local similarity measures were evaluated to identify the criteria for human corrections with regard to alignment quality, analogous to the radiomics approach. Clustering of similarity improvement patterns is applied to reveal priorities in the alignment quality. RESULTS: The radiation therapists prioritized to align the spinal cord closest to the high-dose area. Both target volumes followed with second and third highest priority. The bony pre-match influenced the human correction along the crania-caudal axis. Based on the extracted priorities, a new rigid registration procedure is constructed which is capable of reproducing the corrections of experts. CONCLUSIONS: The proposed approach extracts knowledge of experts performing IGRT corrections to enable new rigid registration methods that are capable of mimicking human decisions. In the future, the deduction of knowledge-based corrections for different cohorts can be established automating such supervised learning approaches.

Accelerated tomotherapy delivery with TomoEdge technique.

TomoEDGE is an advanced delivery form of tomotherapy which uses a dynamic secondary collimator. This plan comparison study describes the new features, their clinical applicability, and their effect on plan quality and treatment speed. For the first 45 patients worldwide that were scheduled for a treatment with TomoEdge, at least two plans were created: one with the previous "standard"mode with static jaws and 2.5 cm field width (Reg 2.5) and one with TomoEdge technique and 5 cm field width (Edge 5). If, after analysis in terms of beam on time, integral dose, dose conformity, and organ at risk sparing the treating physician decided that the Edge 5 plan was not suitable for clinical treatment, a plan with TomoEdge and 2.5 cm field width was created (Edge 2.5) and used for the treatment. Among the 45 cases, 30 were suitable for Edge 5 treatment, including treatments of the head and neck, rectal cancer, anal cancer, malignancies of the chest, breast cancer, and palliative treatments. In these cases, the use of a 5 cm field width reduced beam on time by more than 30% without compromising plan quality. The 5 cm beam could not be clinically applied to treatments of the pelvic lymph nodes for prostate cancer and to head and neck irradiations with extensive involvement of the skull, as dose to critical organs at risk such as bladder (average dose 28 Gy vs. 29 Gy, Reg 2.5 vs. Edge 5), small bowel (29% vs. 31%, Reg 2.5 vs. Edge 5) and brain (average dose partial brain 19 Gy vs. 21 Gy, Reg 2.5 vs. Edge 5) increased to a clinically relevant, yet not statistically significant, amount. TomoEdge is an advantageous extension of the tomotherapy technique that can speed up treatments and thus increase patient comfort and safety in the majority of clinical settings.

Independent calculation of dose distributions for helical tomotherapy using a conventional treatment planning system.

PURPOSE: The dosimetric verification of treatment plans in helical tomotherapy usually is carried out via verification measurements. In this study, a method for independent dose calculation of tomotherapy treatment plans is presented, that uses a conventional treatment planning system with a pencil kernel dose calculation algorithm for generation of verification dose distributions based on patient CT data. METHODS: A pencil beam algorithm that directly uses measured beam data was configured for dose calculation for a tomotherapy machine. Tomotherapy treatment plans were converted into a format readable by an in-house treatment planning system by assigning each projection to one static treatment field and shifting the calculation isocenter for each field in order to account for the couch movement. The modulation of the fluence for each projection is read out of the delivery sinogram, and with the kernel-based dose calculation, this information can directly be used for dose calculation without the need for decomposition of the sinogram. The sinogram values are only corrected for leaf output and leaf latency. Using the converted treatment plans, dose was recalculated with the independent treatment planning system. Multiple treatment plans ranging from simple static fields to real patient treatment plans were calculated using the new approach and either compared to actual measurements or the 3D dose distribution calculated by the tomotherapy treatment planning system. In addition, dose-volume histograms were calculated for the patient plans. RESULTS: Except for minor deviations at the maximum field size, the pencil beam dose calculation for static beams agreed with measurements in a water tank within 2%/2 mm. A mean deviation to point dose measurements in the cheese phantom of 0.89% ± 0.81% was found for unmodulated helical plans. A mean voxel-based deviation of -0.67% ± 1.11% for all voxels in the respective high dose region (dose values >80%), and a mean local voxel-based deviation of -2.41% ± 0.75% for all voxels with dose values >20% were found for 11 modulated plans in the cheese phantom. Averaged over nine patient plans, the deviations amounted to -0.14% ± 1.97% (voxels >80%) and -0.95% ± 2.27% (>20%, local deviations). For a lung case, mean voxel-based deviations of more than 4% were found, while for all other patient plans, all mean voxel-based deviations were within ± 2.4%. CONCLUSIONS: The presented method is suitable for independent dose calculation for helical tomotherapy within the known limitations of the pencil beam algorithm. It can serve as verification of the primary dose calculation and thereby reduce the need for time-consuming measurements. By using the patient anatomy and generating full 3D dose data, and combined with measurements of additional machine parameters, it can substantially contribute to overall patient safety.

Helical tomotherapy of the complete scalp and the ipsilateral lymph nodes in a case of scalp angiosarcoma.

Scalp angiosarcoma represents a therapeutic challenge to all disciplines. This case report demonstrates the potential usefulness of helical tomotherapy (HT) as a new radiotherapeutic treatment option. A 71-year-old woman presented with a superficial angiosarcoma of the scalp, forehead, and left pre- and postauricular areas, with several nodular ulcerating and bleeding lesions. Irradiation of the gross tumor was performed with a total dose of 70 Gy in 2-Gy fractions and of the left cervical lymph nodes with 56 Gy in 1.6-Gy fractions. Good target coverage was achieved without compromising organs at risk, notably the brain. Treatment was very fast (661 seconds per fraction) and was administered with minimal acute toxicity (National Cancer Institute Common Toxicity Criteria: grade 2 erythema and grade 2 dysphagia). During treatment, tumor nodules dissolved into hyperkeratosis. We conclude that with HT, irradiation of the scalp and cervical lymph nodes can be conducted with minimal acute toxicity and without junction problems.

Five-year experience with setup and implementation of an integrated database system for clinical documentation and research.

In radiation oncology, where treatment concepts are elaborated in interdisciplinary collaborations, handling distributed, large heterogeneous amounts of data efficiently is very important, yet challenging, for an optimal treatment of the patient as well as for research itself. This becomes a strong focus, as we step into the era of modern personalized medicine, relying on various quantitative data information, thus involving the active contribution of multiple medical specialties. Hence, combining patient data from all involved information systems is inevitable for analyses. Therefore, we introduced a documentation and data management system integrated in the clinical environment for electronic data capture. We discuss our concept and five-year experience of a precise electronic documentation system, with special focus on the challenges we encountered. We specify how such a system can be designed and implemented to plan, tailor and conduct (multicenter) clinical trials, ultimately reaching the best clinical performance, and enhancing interdisciplinary and clinical research.

A method for testing the performance and the accuracy of the binary MLC used in helical tomotherapy.

During a helical tomotherapy a binary MLC is used for fluence modulation. The 64 pneumatically driven leaves of the MLC are either completely open or closed. The fast and frequent leaf movements result in a high demand of accuracy and stability of the MLC. This article is based on the analytical investigation of the accuracy and the stability of the MLC. Different patterns of MLC movements were generated to investigate the characteristics of the MLC. One of the considered aspects contains the friction between the leaves. The influence of variations of the compressed air on the MLC was also explored. The integrated MVCT detector of the tomotherapy system deposits the treatment data in a matrix. The detector is triggered with the linear accelerator, which is pulsed by 300Hz. The data matrix is available after the treatment. An IDL (Interactive Data Language) routine was programmed in order to analyse the matrix. The points of time, at which the leaves open (POT), and the period, in which the leaves stay open (LOT), were measured and compared with the desired values. That procedure has been repeated several times a week for approximately 6 months to investigate the stability of the MLC. Relative deviations of the LOT from -0.4% to -5.4% were measured. The friction between the leaves had no significant influence on the LOT. The available compressed air, that is used to move the leaves, depends on the number of moving leaves and also on the previous movements of the MLC. Variations of the compressed air resulted in deviations of the LOT from -1.8% to -3.7%. The measured POT deviates from the programmed POT up to -18.4ms±0.7ms. This maximal deviation correlates with a shift of the gantry angle of 0.52̊ which is negligible. The MLC has shown a stable behaviour over the 6 months. A separate consideration of the leaves showed no higher standard deviation of the LOT than ±0.7ms during the investigated time. The variation between the different leaves is much higher than the deviations of LOT caused by friction and changes of compressed air. The deviations of the LOT vary between -2.6ms and -11.0ms. The developed method is feasible in order to recognize a deterioration of the MLC performance.

Connection of European particle therapy centers and generation of a common particle database system within the European ULICE-framework.

BACKGROUND: To establish a common database on particle therapy for the evaluation of clinical studies integrating a large variety of voluminous datasets, different documentation styles, and various information systems, especially in the field of radiation oncology. METHODS: We developed a web-based documentation system for transnational and multicenter clinical studies in particle therapy. 560 patients have been treated from November 2009 to September 2011. Protons, carbon ions or a combination of both, as well as a combination with photons were applied. To date, 12 studies have been initiated and more are in preparation. RESULTS: It is possible to immediately access all patient information and exchange, store, process, and visualize text data, any DICOM images and multimedia data. Accessing the system and submitting clinical data is possible for internal and external users. Integrated into the hospital environment, data is imported both manually and automatically. Security and privacy protection as well as data validation and verification are ensured. Studies can be designed to fit individual needs. CONCLUSIONS: The described database provides a basis for documentation of large patient groups with specific and specialized questions to be answered. Having recently begun electronic documentation, it has become apparent that the benefits lie in the user-friendly and timely workflow for documentation. The ultimate goal is a simplification of research work, better study analyses quality and eventually, the improvement of treatment concepts by evaluating the effectiveness of particle therapy.

Stereotactic single-dose radiotherapy of lung metastases.

BACKGROUND: Stereotactic treatment approaches lead to a significant reduction of irradiated volumes, which should make pulmonary targets more accessible to radiotherapy. PATIENTS AND METHODS: Between May 1997 and December 2005, 61 patients received stereotactic single-dose dose treatment for 71 pulmonary metastases. Doses to the isocenter ranged from 12 to 30 Gy. Survival and local tumor control rates were evaluated prospectively. RESULTS: After a median follow-up period of 14 months the actuarial overall survival was 78.4%, 65.1%, and 47.8% 12, 24, and 36 months after therapy, respectively. There was a significantly better survival (p = 0.023) for patients not developing further metastases during follow-up. The actuarial local progression-free rate was 88.6%, 73.7%, and 63.1% 12, 24, and 36 months after therapy. Although the majority of patients (70.4%) developed perifocal normal-tissue changes, these were not related to clinically relevant toxicities. CONCLUSION: Stereotactic single-dose radiotherapy is a feasible, safe and effective local treatment option for solitary pulmonary metastases in patients with contraindications to surgery or for palliation of symptomatic pulmonary metastases.

Stereotactic single-dose radiotherapy (radiosurgery) of early stage nonsmall-cell lung cancer (NSCLC).

BACKGROUND: The clinical results after stereotactic single-dose radiotherapy of nonsmall-cell lung cancer (NSCLC) stages I and II were evaluated. METHODS: Forty-two patients with biopsy-proven NSCLC received stereotactic radiotherapy. Patients were treated in a stereotactic body frame and breathing motion was reduced by abdominal compression. The single doses used ranged between 19 and 30 Gy/isocenter. RESULTS: After a median follow-up period of 15 months (range, 1.5-72 months) the actuarial overall survival rates and disease-free survival rates were 74.5%, 65.4%, 37.4%, and 70.2%, 49.1%, 49.1% at 12, 24, and 36 months after therapy, respectively. The actuarial local tumor control rates were 89.5%, 67.9%, and 67.9% at 12, 24, and 36 months after therapy, respectively. A significant difference (P = .032) in local tumor control was found for patients receiving 26-30 Gy (n = 32) compared with doses of less than 26 Gy (n = 10). The effect of the tumor volume on local tumor control was also evaluated. Although the difference was not statistically significant (P = .078), the subgroup of tumors with a tumor volume of less than 12 cm(3) (n = 10) experienced no tumor recurrence. Thirteen (31%) patients developed metastases during follow-up, whereas isolated regional lymph node recurrence was only encountered in 2 patients. No clinically significant treatment-associated side effects were documented. CONCLUSIONS: Stereotactic single-dose radiotherapy is a safe and effective treatment option for patients with early stage NSCLC not suitable for surgery. Especially for small tumor volumes it seems to be equally effective as hypofractionated radiotherapy, while minimizing the overall treatment time.