Educational Video for Brain Cancer

Overseen by Caroline Chung

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. ^{1 2 3 4 5}

Is the Educational Video for Brain Cancer treatment safe for humans?

The research articles provided do not contain specific safety data for the Educational Video for Brain Cancer treatment or its other names. They focus on the side effects of chemotherapy and radiation therapy, which are different treatments. ^{6 7 8 9 10}

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. ^{11 12 13 14 15}

Research Team

Caroline Chung

Principal Investigator

M.D. Anderson Cancer Center

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

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 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.

Participant Groups

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+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

How Advances in Imaging Will Affect Precision Radiation Oncology. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Radiographic read paradigms and the roles of the central imaging laboratory in neuro-oncology clinical trials. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

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

6. Japan pubmed.ncbi.nlm.nih.gov

[Countermeasures to neurological adverse reactions of chemotherapy]. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

Dose-effect relationships for adverse events after cranial radiation therapy in long-term childhood cancer survivors. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A Framework for Sharing Radiation Dose Distribution Maps in the Electronic Medical Record for Improving Multidisciplinary Patient Management. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Imaging spectrum of immunomodulating, chemotherapeutic and radiation therapy-related intracranial effects. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Implementation of a DVH Registry to provide constraints and continuous quality monitoring for pediatric CSI treatment planning. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Patient Education: A Comparison of Teaching Strategies for Patients With Brain Neoplasms. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Medical care of patients with brain tumors. [2012]

13. Korea (South) pubmed.ncbi.nlm.nih.gov

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

14. United States pubmed.ncbi.nlm.nih.gov

Pearls: primary brain tumors. [2018]

15. Germany pubmed.ncbi.nlm.nih.gov

[Brain tumor immunotherapy-Possibilities and challenges of personalization]. [2021]