Educational Video for Brain Cancer

Overseen By Caroline Chung

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Cognitive symptoms, Psychiatric symptoms, Poor performance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

117 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a personalized video can reduce anxiety for brain cancer patients and their caregivers during radiation treatment. Patients watch a video explaining symptoms and side effects specific to their brain tumor type. The goal is to determine if this video can improve quality of life by reducing anxiety. Patients with a recent brain tumor diagnosis and their caregivers, who can complete surveys in English, may qualify for this study. As an unphased study, this trial offers a unique opportunity to contribute to innovative approaches that may enhance patient care and support.

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 prior data suggests that this video intervention is safe for brain cancer patients and their caregivers?

Research has shown that using a personalized video based on brain scans is safe for patients. As a video, it avoids physical side effects associated with medicines or surgeries. The goal is to provide information that may help reduce anxiety in brain cancer patients undergoing radiation treatment. Similar situations have reported no negative effects from watching educational videos. This method aims to improve understanding and comfort, making it very well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Educational Video for Brain Cancer because it offers a personalized approach to patient education. Unlike standard care, which typically involves verbal and written materials, this innovative method includes a customized video that visually explains a patient's specific tumor, brain areas affected, and potential symptoms. By using neuro-imaging features, the video helps patients and their caregivers better understand the condition and treatment, potentially improving communication and patient outcomes.

What evidence suggests that this video intervention is effective for reducing anxiety in brain cancer patients?

Research shows that educational videos can help reduce anxiety in patients undergoing stressful medical treatments. In this trial, participants in one arm will receive a personalized video using images from their own brain scans to explain their condition and possible side effects from radiation. This tailored approach aims to make complex medical information more relatable and easier to understand. Studies suggest that when patients and their caregivers better understand the treatment process, their anxiety often decreases. Although direct data for this video intervention is limited, personalized education has shown promise in similar situations. ^{1 2 3 4 5}

Who Is on the Research Team?

Caroline Chung

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Customized Neuro-Imaging Referenced Symptom Video

Trial Overview The 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.

How Is the Trial Designed?

Group I: Arm I (NIRS) Experimental Treatment 4 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 Control 2 Interventions

Patients receive standard of care verbal and written education materials.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Patients with brain tumors often experience significant neurological issues, including motor dysfunction, cognitive decline, and emotional problems, necessitating focused rehabilitation efforts.

An individualized, multidisciplinary rehabilitation approach is essential to address the diverse functional impairments caused by both the tumor and its treatment, improving overall patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain Tumor Rehabilitation: Symptoms, Complications, and Treatment Strategy. Park, J., Park, YG.[2023]

The use of multi-modality imaging allows for a more detailed and personalized assessment of tumor response to therapy by analyzing images taken at multiple time points for each patient.

Quantitative analysis of serial images helps in effectively combining different types of information, which can enhance the accuracy of evaluating how well a treatment is working on a tumor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New PET/CT Features for the Evaluation of Tumor Response. Lu, W.[2020]

Anticoagulation therapy using low-molecular-weight heparins is considered safe for patients with brain tumors experiencing thromboembolic complications, even when they are on antiangiogenic treatments.

Non-enzyme-inducing antiepileptic drugs are recommended for seizure management in brain tumor patients, as they are effective and do not interact with chemotherapy, while corticosteroids should be used minimally for treating edema and tapered quickly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical care of patients with brain tumors. Drappatz, J.[2012]

Personalized treatment approaches for brain tumors are becoming feasible, particularly in immunotherapy, which allows for targeted interventions and systematic follow-up to assess treatment responses.

Early clinical trials indicate that understanding the individual and spatial-temporal heterogeneity of brain tumors can lead to more effective and tailored therapies, although these methods are not yet part of standard treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Brain tumor immunotherapy-Possibilities and challenges of personalization]. Platten, M., Bunse, L., Wick, W.[2021]

Primary brain tumors often show nonspecific or subtle symptoms that can lead to misdiagnosis, highlighting the importance of careful clinical evaluation.

Advancements in brain imaging technology have significantly enhanced the ability of physicians, especially neurologists, to accurately diagnose and manage brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pearls: primary brain tumors. Nolan, C., Gavrilovic, IT.[2018]

Symptoms related to primary brain tumors can affect patients from diagnosis and may indicate tumor recurrence, highlighting the need for comprehensive symptom assessment beyond just tumor size and survival rates.

Patient-reported outcome measures are being developed and validated to better capture the impact of symptoms on quality of life, and there is a call for standardized guidelines to ensure consistent use in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient reported endpoints for measuring clinical benefit in (high grade glioma) primary brain tumor patients. Armstrong, TS., Gilbert, MR.[2022]

Radiation oncology is evolving to incorporate advanced imaging technologies and data analytics, which will enhance the precision and personalization of cancer treatments, allowing for better adaptation of therapy based on individual patient responses.

The integration of multimodal imaging and biomarkers, such as tumor genomics and circulating tumor cell assays, is essential for optimizing radiation therapy and improving therapeutic outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Advances in Imaging Will Affect Precision Radiation Oncology. Jaffray, DA., Das, S., Jacobs, PM., et al.[2019]

In a study of 1362 childhood cancer survivors, over 80% of those treated with cranial radiation therapy (CRT) experienced multiple adverse events (AEs), with nearly half reporting at least five, indicating a significant increase in health complications compared to those not treated with CRT.

The research established a clear dose-effect relationship between the equivalent dose in 2-Gy fractions (EQD(2)) of CRT and the prevalence and severity of AEs, highlighting that higher radiation doses correlate with more severe health issues, including cognitive and neurological problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-effect relationships for adverse events after cranial radiation therapy in long-term childhood cancer survivors. van Dijk, IW., Cardous-Ubbink, MC., van der Pal, HJ., et al.[2022]

The study highlights the importance of recognizing treatment-related neuroimaging side effects, which can present as specific neurologic symptoms and signs, making accurate diagnosis challenging for radiologists.

Through a case-based review, the authors illustrate common and uncommon medication-induced imaging manifestations, emphasizing the need for radiologists to be aware of these abnormalities to improve diagnostic accuracy in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging spectrum of immunomodulating, chemotherapeutic and radiation therapy-related intracranial effects. Lincoln, CM., Fata, P., Sotardi, S., et al.[2019]

Anti-tumor drugs can cause significant adverse reactions in both the central and peripheral nervous systems, making prevention and early detection crucial for patient safety.

Currently, there are no clinically proven neuroprotectants to prevent these adverse reactions, although some experimental neuroprotectants have shown efficacy in animal studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Countermeasures to neurological adverse reactions of chemotherapy]. Mano, K.[2006]

A new framework allows radiation dose distribution maps to be uploaded to the medical center's PACS, making radiation treatment history accessible to all medical providers involved in a patient's care.

This system enhances communication during tumor board discussions and improves oncologic decision-making by providing a clear visual summary of a patient's radiation history, ultimately aiming to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Framework for Sharing Radiation Dose Distribution Maps in the Electronic Medical Record for Improving Multidisciplinary Patient Management. Savjani, RR., Salamon, N., Deng, J., et al.[2021]

The RANO criteria, established in 2010, provide a framework for assessing tumor response in intracranial tumors, but there is a lack of standardized methods for their application in clinical trials.

This review outlines essential steps for radiographic assessments and recommends specific changes, such as standardized image acquisition and hybrid reader paradigms, to improve the methodology for evaluating treatment efficacy in neuro-oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiographic read paradigms and the roles of the central imaging laboratory in neuro-oncology clinical trials. Ellingson, BM., Brown, MS., Boxerman, JL., et al.[2023]

In a study of 30 patients with brain neoplasms, a specific teaching strategy (strategy 3) showed higher post-test knowledge scores, indicating it may enhance understanding of their diagnosis, although the difference was not statistically significant.

Patients who received the TEAL-reinforced education (strategy 3) not only retained knowledge better but also made fewer calls to their healthcare team, suggesting improved confidence and understanding in managing their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Education: A Comparison of Teaching Strategies for Patients With Brain Neoplasms. Stuart, TA., Stutzman, SE., Hicks, AD., et al.[2020]

Current treatments for primary brain tumors are still not effective enough, despite significant advancements in understanding their molecular and genomic characteristics.

Incorporating molecular signatures and patient-reported outcomes into clinical trials is showing promise in improving treatment strategies, but challenges remain in optimizing patient selection and implementing these measures effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On the pathway to success: defining subtypes of gliomas for better treatment selection and refining the meaning of success. Gilbert, MR.[2021]

The implementation of a dose-volume histogram registry (DVHR) significantly improved the standardization of craniospinal irradiation (CSI) planning for pediatric patients, which is crucial for minimizing long-term side effects associated with radiation therapy.

Using DVHR-derived data allowed for the establishment of standardized dosimetric constraints, leading to enhanced consistency in treatment techniques across different radiation modalities like TomoTherapy and IMRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a DVH Registry to provide constraints and continuous quality monitoring for pediatric CSI treatment planning. Sepulveda, E., Patrick, H., Freeman, CR., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04479696

Customized Neuro-Imaging Referenced Symptom Video ... This trial studies whether a customized video intervention can help to reduce anxiety in brain cancer patients undergoing radiation treatment and their ...

2. withpower.com withpower.com/trial/phase-glioblastoma-5-2019-7ec67

Educational Video for Brain Cancer This trial studies whether a customized video intervention can help to reduce anxiety in brain cancer patients undergoing radiation treatment and their ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-03698

Customized Neuro-Imaging Referenced Symptom Video ... This trial studies whether a customized video intervention can help to reduce anxiety in brain cancer patients undergoing radiation treatment and their ...

4. mdanderson.org mdanderson.org/research/departments-labs-institutes/departments-divisions/central-nervous-system-radiation-oncology/clinical-trials.html

Brain tumor clinical trials ... brain cancer patients undergoing radiation treatment and their caregivers. A customized neuro-imaging referenced symptom video that describes symptoms and ...

5. mdanderson.org mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2018-0097.html

Clinical Trials Detail This trial studies whether a customized video intervention can help to reduce anxiety in brain cancer patients undergoing radiation treatment and their ...