Educational Video for Brain Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: M.D. Anderson Cancer Center
Disqualifiers: Cognitive symptoms, Psychiatric symptoms, Poor performance, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
This trial studies whether a customized video intervention can help to reduce anxiety in brain cancer patients undergoing radiation treatment and their caregivers. A customized neuro-imaging referenced symptom video that describes symptoms and side effects specific to the patients' tumor may result in an early and sustained reduction in anxiety and distress during and after radiation treatment, thereby improving quality of life.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of this treatment for brain cancer?
The research highlights the importance of personalized and precise imaging in radiation therapy, which is a key component of the treatment being studied. Advances in imaging and patient-reported outcomes are increasingly being used to tailor treatments to individual patients, potentially improving their effectiveness and quality of life.12345
Is the Educational Video for Brain Cancer treatment safe for humans?
How is the educational video treatment for brain cancer different from other treatments?
The educational video treatment is unique because it focuses on providing patients and their families with clear and accessible information about brain cancer, its symptoms, and treatments, which can help them better understand and manage their condition. Unlike traditional medical treatments, this approach emphasizes education and empowerment rather than direct medical intervention.1112131415
Eligibility Criteria
This trial is for adult patients with newly diagnosed glioma (grades 2-4) who are about to start a 6-week radiotherapy post-surgery and can fill out questionnaires in English. It also includes their adult caregivers who can do the same. Those with significant cognitive or psychiatric issues, or poor performance status (KPS < 60), cannot participate.Inclusion Criteria
CAREGIVER ELIGIBILITY CRITERIA: The patient who the caregiver is accompanying is consented for participation on the study
I have a newly diagnosed brain tumor and am set for radiotherapy after surgery.
PATIENT ELIGIBILITY CRITERIA: Has a post-operative diagnostic magnetic resonance imaging (MRI) of the brain with and without contrast acquired within 4 weeks of the start of radiotherapy
See 3 more
Exclusion Criteria
My caregiver cannot complete questionnaires due to cognitive or psychiatric issues.
I am unable to complete daily tasks without assistance.
I am able to complete questionnaires without significant cognitive or psychiatric issues.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation Treatment
Patients undergo radiation treatment for brain tumors. In Arm I, patients also receive a customized NIRS video intervention.
6 weeks
Weekly visits for radiation sessions
Follow-up
Participants are monitored for changes in anxiety and quality of life after radiation treatment.
1 month
1 visit (in-person)
Treatment Details
Interventions
- Customized Neuro-Imaging Referenced Symptom Video (Behavioural Intervention)
Trial OverviewThe study tests if a personalized video explaining symptoms and side effects related to the patient's brain tumor can reduce anxiety for both patients and caregivers during radiation treatment, potentially improving quality of life.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (NIRS)Experimental Treatment4 Interventions
Patients receive standard of care verbal and written education materials. Patients also receive a customized video which includes a description of each of their tumor, functional areas of the brain affected, and possible symptoms from the tumor and radiation treatment based on the neuro-imaging features. Patients and their caregivers watch the video together or separately over 1.5-3 minutes before the end of the first week of radiation treatment. Within 2 weeks after watching the NIRS video, patients complete an optional survey over 5-10 minutes.
Group II: Arm II (standard of care)Active Control2 Interventions
Patients receive standard of care verbal and written education materials.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Patient reported endpoints for measuring clinical benefit in (high grade glioma) primary brain tumor patients. [2022]Symptom occurrence impacts primary brain tumor patients from the time of diagnosis and often heralds recurrence. In addition, the therapy can also result in symptoms that may compound tumor-associated symptoms, further impacting the patient's function and overall quality of life. There is increasing recognition that clinical studies evaluating tumor response using only measures of tumor size on imaging or survival are inadequate in brain tumor patients. Many symptoms can only be assessed from the patient, and patient reported outcome measures have been developed and have adequate reliability and validity. These measures are beginning to be incorporated into clinical trials. Guidelines on their use and meaning are needed to standardize assessment across trials and facilitate measurement of clinical benefit.
How Advances in Imaging Will Affect Precision Radiation Oncology. [2019]Radiation oncology is 1 of the most structured disciplines in medicine. It is of a highly technical nature with reliance on robotic systems to deliver intervention, engagement of diverse expertise, and early adoption of digital approaches to optimize and execute the application of this highly effective cancer treatment. As a localized intervention, the dependence on sensitive, specific, and accurate imaging to define the extent of disease, its heterogeneity, and adjacency to normal tissues directly affects the therapeutic ratio. Image-based in vivo temporal monitoring of the response to treatment enables adaptation and further affects the therapeutic ratio. Thus, more precise intervention will enable fractionation schedules that better interoperate with advances such as immunotherapy. In the data set-rich era that promises precision and personalized medicine, the radiation oncology field will integrate these new data into highly protocoled pathways of care that begin with multimodality prediction and enable patient-specific adaptation of therapy based on quantitative measures of the individual's dose-volume temporal trajectory and midtherapy predictions of response. In addition to advancements in computed tomography imaging, emerging technologies, such as ultra-high-field magnetic resonance and molecular imaging will bring new information to the design of treatments. Next-generation image guided radiation therapy systems will inject high specificity and sensitivity data and stimulate adaptive replanning. In addition, a myriad of pre- and peritherapeutic markers derived from advances in molecular pathology (eg, tumor genomics), automated and comprehensive imaging analytics (eg, radiomics, tumor microenvironment), and many other emerging biomarkers (eg, circulating tumor cell assays) will need to be integrated to maximize the benefit of radiation therapy for an individual patient. We present a perspective on the promise and challenges of fully exploiting imaging data in the pursuit of personalized radiation therapy, drawing from the presentations and broader discussions at the 2016 American Society of Therapeutic Radiation Oncology-National Cancer Institute workshop on Precision Medicine in Radiation Oncology (Bethesda, MD).
Radiographic read paradigms and the roles of the central imaging laboratory in neuro-oncology clinical trials. [2023]Determination of therapeutic benefit in intracranial tumors is intimately dependent on serial assessment of radiographic images. The Response Assessment in Neuro-Oncology (RANO) criteria were established in 2010 to provide an updated framework to better characterize tumor response to contemporary treatments. Since this initial update a number of RANO criteria have provided some basic principles for the interpretation of changes on MR images; however, the details of how to operationalize RANO and other criteria for use in clinical trials are ambiguous and not standardized. In this review article designed for the neuro-oncologist or treating clinician, we outline essential steps for performing radiographic assessments by highlighting primary features of the Imaging Charter (referred to as the Charter for the remainder of this article), a document that describes the clinical trial imaging methodology and methods to ensure operationalization of the Charter into the workings of a clinical trial. Lastly, we provide recommendations for specific changes to optimize this methodology for neuro-oncology, including image registration, requirement of growing tumor for eligibility in trials of recurrent tumor, standardized image acquisition guidelines, and hybrid reader paradigms that allow for both unbiased measurements and more comprehensive interpretation.
On the pathway to success: defining subtypes of gliomas for better treatment selection and refining the meaning of success. [2021]The treatment for most patients with primary brain tumors remains inadequate. Despite an overwhelming increase in our knowledge of the molecular and genomic changes in these cancers, translation of these findings to effective therapies remains the exception. As evidenced by the series of articles in this issue, the incorporation of molecular signatures and patient-reported outcome measures into clinical trials is becoming increasingly successful. These efforts recently yielded a treatment-determining predictive marker, but challenges remain in optimizing marker-based patient selection and systematic implementation of patient-reported outcomes to maximize the risk-to-benefit assessment, thereby achieving individualized treatment.
New PET/CT Features for the Evaluation of Tumor Response. [2020]With the emerging multi-modality imaging performed at multiple time points for each patient, it becomes more important to analyze the serial images quantitatively, select and combine both complementary and contradictory information from various sources, for accurate and personalized evaluation of tumor response to therapy.
[Countermeasures to neurological adverse reactions of chemotherapy]. [2006]Anti-tumor drugs often cause adverse reactions on both central and peripheral nervous systems. Prevention and early detection is essential, since proper treatment scarcely protects against adverse reactions once appeared in the nervous system. Precise neurological examination at bed side must be done before starting the chemotherapy and along the course periodically. Radiological diagnosis (including CT and MRI) and electrophysiological evaluation (including electroencephalogram and nerve conduction study) are informative as supplemental tools. Neurological and psychiatric symptoms and signs resulting from the major adverse reactions are reviewed, taken notice of prevention and countermeasures. Inclusive of amifostine there exist no neuroprotectants proving clinical utility at present. Some neuroprotectants are briefly introduced, of which efficacy animal experiments have demonstrated.
Dose-effect relationships for adverse events after cranial radiation therapy in long-term childhood cancer survivors. [2022]To evaluate the prevalence and severity of clinical adverse events (AEs) and treatment-related risk factors in childhood cancer survivors treated with cranial radiation therapy (CRT), with the aim of assessing dose-effect relationships.
A Framework for Sharing Radiation Dose Distribution Maps in the Electronic Medical Record for Improving Multidisciplinary Patient Management. [2021]Radiation oncology practices use a suite of dedicated software and hardware that are not common to other medical subspecialties, making radiation treatment history inaccessible to colleagues. A radiation dose distribution map is generated for each patient internally that allows for visualization of the dose given to each anatomic structure volumetrically; however, this crucial information is not shared systematically to multidisciplinary medical, surgery, and radiology colleagues. A framework was developed in which dose distribution volumes are uploaded onto the medical center's picture archiving and communication system (PACS) to rapidly retrieve and review exactly where, when, and to what dose a lesion or structure was treated. The ability to easily visualize radiation therapy information allows radiology clinics to incorporate radiation dose into image interpretation without direct access to radiation oncology planning software and data. Tumor board discussions are simplified by incorporating radiation therapy information collectively in real time, and daily onboard imaging can also be uploaded while a patient is still undergoing radiation therapy. Placing dose distribution information into PACS facilitates central access into the electronic medical record and provides a succinct visual summary of a patient's radiation history for all medical providers. More broadly, the radiation dose map provides greater visibility and facilitates incorporation of a patient's radiation history to improve oncologic decision making and patient outcomes. Keywords: Brain/Brain Stem, CNS, MRI, Neuro-Oncology, Radiation Effects, Radiation Therapy, Radiation Therapy/Oncology, Radiosurgery, Skull Base, Spine, Technology Assessment Supplemental material is available for this article. © RSNA, 2021 See also commentary by Khandelwal and Scarboro in this issue.
Imaging spectrum of immunomodulating, chemotherapeutic and radiation therapy-related intracranial effects. [2019]A wide range of treatment-related side effects result in specific neurologic symptoms and signs and neuroimaging features. Even to the most seasoned neuroradiologist, elucidating therapy-related side effects from other common mimics can be challenging. We provide a pictorial survey of some common and uncommon medication-induced and therapy-related neuroimaging manifestations, discuss pathophysiology and common pitfalls in imaging and diagnosis.
Implementation of a DVH Registry to provide constraints and continuous quality monitoring for pediatric CSI treatment planning. [2021]Craniospinal irradiation (CSI) is a complex radiation therapy technique that is used for patients, often children and teenagers/young adults, with tumors that have a propensity to spread throughout the central nervous system such as medulloblastoma. CSI is associated with important long-term side effects, the risk of which may be affected by numerous factors including radiation modality and technique. Lack of standardization for a technique that is used even in larger radiation oncology departments only a few times each year may be one such factor and the current ad hoc manner of planning new CSI patients may be greatly improved by implementing a dose-volume histogram registry (DVHR) to use previous patient data to facilitate prospective constraint guidance for organs at risk. In this work, we implemented a DVHR and used it to provide standardized constraints for CSI planning. Mann-Whitney U tests and mean differences at 95% confidence intervals were used to compare two cohorts (pre- and post-DVHR intervention) at specific dosimetric points to determine if observed improvements in standardization were statistically significant. Through this approach, we have shown that the implementation of dosimetric constraints based on DVHR-derived data helped improve the standardization of pediatric CSI planning at our center. The DVHR also provided guidance for a change in CSI technique, helping to achieve practice standardization across TomoTherapy and IMRT.
Patient Education: A Comparison of Teaching Strategies for Patients With Brain Neoplasms. [2020]A diagnosis of cancer, specifically a brain neoplasm, can be daunting and confusing to patients and their family members. It is important to find ways to provide education about diagnosis, symptoms, medications, treatment, and side effects in a usable and retrievable format.
Medical care of patients with brain tumors. [2012]Patients with brain tumors require close attention to medical issues resulting from their disease or its therapy. Effective medical management results in decreased morbidity and mortality and improved quality of life. The most frequent neurology-related issues that arise in these patients include seizures, peritumoral edema, venous thromboembolism, fatigue, and cognitive dysfunction. This article focuses on the most recent findings for the management of the most relevant medical complications among patients with brain tumors.
Brain Tumor Rehabilitation: Symptoms, Complications, and Treatment Strategy. [2023]Brain tumors are receiving increasing attention in cancer rehabilitation due to their high rate of neurological deterioration. Motor dysfunction, cognitive deterioration, and emotional problems are commonly present in patients with brain tumors. Other medical complications, such as seizures, headache, and dysphagia are also common. An individualized multidisciplinary rehabilitation intervention is necessary to treat functional impairment due to the tumor itself and/or treatment-related dysfunction. Herein, we discuss rehabilitation treatment strategies in relation to the neurological and functional complications that commonly occur in patients with brain tumors.
Pearls: primary brain tumors. [2018]Most physicians in general, and neurologists in particular, enjoy tackling challenging clinical cases; making the correct diagnosis can be quite satisfying. However, primary brain tumors may present with nonspecific or subtle signs that can sometimes be missed or misinterpreted. More than ever, brain imaging has improved our ability to correctly diagnose and care for patients with brain tumors. We have included some cases from the Department of Neurology at Memorial Sloan-Kettering Cancer Center (New York, NY) to help illustrate some "pearls" when considering the diagnostic possibility of a brain tumor.
[Brain tumor immunotherapy-Possibilities and challenges of personalization]. [2021]Brain tumors represent a special interdisciplinary challenge in the treatment of neurological disorders. Insights into the interindividual as well as the spatial and temporal intraindividual heterogeneity require entirely new personalized treatment approaches. Particularly in the field of immunotherapy there are possibilities for targeted interventions and systematic follow-up for assessment of response to treatment. Although not yet integrated into the standard treatment, early clinical trials in recent years have shown the feasibility of systematic personalized treatment approaches. The conceptual and regulatory implications of these approaches reach far beyond the field of neuro-oncology.