Quality-of-Life Assessment for Cancer Patients with Neuropathy During COVID-19

Overseen By Sarah Prinsloo

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: No prior consent

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how cancer patients with neuropathy (nerve pain) manage life during the COVID-19 pandemic. Researchers aim to determine if experiences differ between those who received neurofeedback therapy (a treatment that balances brain activity) and those who did not. The goal is to enhance care for individuals with chronic pain during global health crises. Candidates may qualify if they participated in specific past trials and have an active email. Participants will complete a short online questionnaire about their COVID-19 experiences and its impact on their quality of life. As an unphased study, this trial offers a unique opportunity to contribute to understanding and improving care for chronic pain during global health crises.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that neurofeedback is safe for cancer patients with neuropathy?

Research has shown that neurofeedback, a therapy that helps people control their brain activity, is generally safe. Studies have found that most people tolerate this method well. Neurofeedback, a type of biofeedback, has been used to help manage stress and other health issues. Studies checking its safety have reported no serious side effects, suggesting that neurofeedback is a low-risk treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about neurofeedback for cancer patients with neuropathy because it offers a unique, non-invasive way to manage symptoms. Unlike traditional treatments like medications or physical therapy, neurofeedback trains patients to modulate their brain activity, potentially reducing pain and improving well-being without side effects. This method could empower patients to take an active role in their treatment, providing a sense of control during challenging times.

What evidence suggests that neurofeedback is effective for improving quality of life in cancer patients with neuropathy during the COVID-19 pandemic?

Research has shown that neurofeedback, a therapy that helps balance brain activity, may improve issues like attention and memory. In one study, patients felt less anxious and experienced less pain after neurofeedback therapy. Another study found it could help reduce depression. These findings suggest neurofeedback might benefit cancer patients with nerve pain, particularly by enhancing their quality of life during challenging times like the COVID-19 pandemic. Although more research is needed, early results are promising for managing symptoms related to brain function and mood. ^{6 7 8 9 10}

Who Is on the Research Team?

Sarah Prinsloo

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Must have participated in one of the following protocols: 2015-0399, 2012-0642, or 2010-0675

Has an active email address or can be contacted by MyChart or personal email

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Questionnaire

Participants complete an online questionnaire about their experiences regarding the COVID-19 pandemic, including testing, risks of exposure, and quality of life impacts

15 minutes

1 online session

Follow-up

Participants are monitored for changes in health-related quality of life and COVID-19-specific distress

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Neurofeedback

How Is the Trial Designed?

Group I: Observational (questionnaire, quality of life) Experimental Treatment 2 Interventions

Patients complete an online questionnaire over 15 minutes about their experiences regarding the COVID-19 pandemic including testing, risks of exposure, whether people they know have acquired COVID-19, as well as questions on how the pandemic has impacted their quality of life.

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11925212/

Neurofeedback for COVID-19 Brain Fog: A Secondary Analysis The patient reported improved attention and memory, reduced anxiety, and less pain, although depression reduction was less. These results ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S092549272300001X

Review of EEG-based neurofeedback as a therapeutic ... The study showed that EEG-NF based on ALAY theory was associated with a reduction in depressive symptoms. Mennella et al. (2017) reported results similar to ...

3. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2022.837972/full

Possible Mechanisms Underlying Neurological Post- ... In the following sections, we will discuss a potential role of biofeedback as a possible therapy for the treatment of post-COVID-19 complications. The proposed ...

4. nature.com nature.com/articles/s41598-022-19068-w

Development of a brain wave model based on the ... The purpose of our study was to show the effectiveness of EEG biofeedback with a Quantitative Electroencephalogram of the brainwave pattern after having COVID- ...

5. researchgate.net researchgate.net/publication/367842383_EEG_NEUROFEEDBACK_IN_THE_TREATMENT_OF_COGNITIVE_DYSFUNCTIONS_AFTER_THE_INFECTION_OF_SARS-COV-2_AND_LONG_COVID-19

EEG NEUROFEEDBACK IN THE TREATMENT OF ... The aim of the study was to evaluate the effectiveness of neurotherapy (EEG neurofeedback and goal-oriented cognitive training) in the treatment ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4892319/

Neurofeedback: A Comprehensive Review on System Design ... Neurofeedback is a kind of biofeedback, which teaches self-control of brain functions to subjects by measuring brain waves and providing a feedback signal.

7. mayoclinic.org mayoclinic.org/tests-procedures/biofeedback/about/pac-20384664

Biofeedback Biofeedback is a type of mind-body technique you use to control some of your body's functions, such as your heart rate, breathing patterns and muscle responses.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352154615000625

Cognitive enhancement through real-time fMRI ... Based on previous studies and conceptual arguments, the neurofeedback method is considered safe [66]. ... data, compared to the more traditional EEG ( ...

9. va.gov va.gov/WHOLEHEALTH/professional-resources/Biofeedback.asp

Biofeedback - Whole Health Biofeedback can improve health issues that are caused or worsened by stress. Using a two-step process, biofeedback can help you relax and reduce your stress.

10. nature.com nature.com/articles/s41598-023-28344-2

a double-blinded safety and feasibility randomized placebo ... An independent Data and Safety Monitoring Committee monitored the safety of the study. A serious adverse event (SAE) was defined as any ...