Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Quality of Life

Healthy participants fill out several questionnaires asking questions about memory and concentration, mood, fatigue, how they have been feeling, and general quality of life. The questionnaires should take about 30 minutes to complete. Electroencephalography (EEG) and magnetic resonance imaging (fMRI) scan performed. These should take a total of about 90 minutes to complete.

Participants fill out several questionnaires at baseline, at completion of meditation classes, and at follow up visit. The forms should take about 30 minutes to complete. Participants complete computer tests to check memory and concentration taking about 20 minutes to complete. Electroencephalography (EEG) performed at baseline, at completion of classes, and at follow up visit. Participants have magnetic resonance imaging (fMRI) scan of brain at baseline, at completion of meditation classes, and at follow up visit. Tests, EEG, and fMRI should take a total of about 90 minutes to complete. Participants take part in up to 16 meditation classes for a total of 8 weeks. All sessions videotaped.

Participants fill out several questionnaires at baseline and at follow up visit. The forms should take about 30 minutes to complete. Participants complete computer tests to check memory and concentration taking about 20 minutes to complete. Tests, EEG, and fMRI should take a total of about 90 minutes to complete. Participants receive the standard of care for cancer patients.

After 8 week follow up visit, Wait-List Group offered meditation program.

Participants fill out several questionnaires asking questions about memory and concentration, mood, fatigue, how they have been feeling, and general quality of life. The questionnaires should take about 30 minutes to complete.

Meditation Group and Wait-List Group also complete questionnaires at follow up visit.

Questionnaires

Meditation Group and Wait-List Group: Electroencephalography (EEG) performed at baseline and at follow up visit. During EEG, 3 tests to check attention, short-term memory, and levels of emotions.

Healthy Control Group: Electroencephalography (EEG) performed at study visit. During EEG, 3 tests to check attention, short-term memory, and levels of emotions.

Electroencephalography (EEG)

Healthy Control Group: Magnetic resonance imaging (fMRI) scan performed.

Meditation Group and Wait-List Group: Magnetic resonance imaging (fMRI) scan of brain performed at baseline and at follow up visit.

Magnetic Resonance Imaging (fMRI

Participants take part in up to 16 meditation classes for a total of 8 weeks. All sessions videotaped.

Meditation Classes

Lorenzo Cohen, PHD

The goal of this research study is to test Tibetan meditation as a therapy to teach cancer patients to change their brain functioning and to improve quality of life. Researchers want to compare the cancer patients' outcomes to people who have never had cancer.

Tibetan Meditation Program:

During the meditation program, you will learn several concepts such as focus, visualization, and sound. You will have up to 16 classes for 8 weeks. They should take about 60 minutes each.

First Study Visit:

If you choose to take part in this study, you will be asked to fill out several questionnaires. You will be asked questions about your memory and concentration, mood, fatigue, how you have been feeling, and your general quality of life. The forms should take about 30 minutes to complete.

You will complete some computer tests to check your memory and concentration. For example, you will be asked to remember a list of words and then be asked to recall them later. These tests should take about 20 minutes to complete.

You will then have an electroencephalography (EEG) done. An EEG checks a person's brainwaves. During the EEG, a snug cap which contains small electrodes will be placed on your head to measure the electrical patterns coming from the brain. This is like the way a doctor listens to your heart from the surface of your skin. During recording of the EEG, you will be asked to complete 3 tests to check your attention, short-term memory, and levels of emotions. For example, for one test you will use a use a keypad to choose a word's name that is a color (such as if the word "blue" written in the color red, the correct answer would be red).The EEG and tests will take about 45 minutes to one hour.

You will also have a functional magnetic resonance imaging (fMRI) scan of your brain. During the scan, you will lie down on your back with both arms extended by your sides. You will be fitted with earplugs and/or headphones to help dampen the noise caused by the scanner. The lights will also be dimmed. You will then lie still until the scan is over. The scan will take about 20 minutes.

The tests, EEG, and fMRI should take a total of about 90 minutes to complete.

Blood (about 1 tablespoon) will be drawn for tests to measure hormones and your immune system responses. This should take about 15 minutes.

All assessments will be performed at baseline and after the completion of classes.

Study Groups:

After the first study visit, you will be randomly assigned to 1 of 2 study groups. You will have about a 1 out of 2 chance of being assigned to each group. The groups are randomly assigned, but it is also based on other factors such as your age and the status of the disease.

Participants in the first group will take part in a meditation program. You will take part in up to 16 meditation classes for a total of 8 weeks. The meditation sessions may take place on any 2 days of the week at MD Anderson. During the meditation sessions, you will do deep breathing and visualization exercises and produce some sounds like "Ah." Each session will last about 60 minutes. A trained meditation instructor will teach the meditation sessions. Participants will be asked to continue daily meditation practice at home outside of the classes and will be given a CD to guide home practice. All sessions will be videotaped. This is so the researchers can keep track of the quality of the sessions. The audio and video files are digital and will be deleted after all the data are studied.

Participants in the second group will be in a wait-list group. You will continue to receive the standard of care for cancer patients, but you will not take part in the meditation program. You will be given the opportunity to take part in the meditation program and similar measures will be collected from you at similar times as that described below.

All participants must agree not to take part in any other meditation programs for as long as you take part in this study.

Follow-up Study Visit:

Within a week after the last meditation session (8 weeks after baseline), all participants will be asked to fill out a packet of questionnaires (like the ones at the first visit). It should take about 50 minutes to complete all of the questionnaires. You will have some tests to check your memory and concentration, similar to the tests you took at your initial visit. You will have another EEG and fMRI. You will have blood drawn.

After the 8 week follow-up, if you were in the meditation group your participation on this study will be over. If you were in the wait-list group you will be offered the meditation program and you will complete the same questionnaires as before. You will not have any more EEG or fMRI measurements or blood drawn.

You may receive reminder calls for each session and the follow-up study visit.

Length of Study:

If you are in the treatment group, you will be on study for up to 8 weeks. If you are in the waitlist group and decide to take meditation classes after the first 8 weeks, you may be on study for up to 16 weeks.

This is an investigational study.

Up to 140 participants will take part in this study. Up to 10 pilot participants without cancer will be take part in this study. Up to 40 participants without cancer and up to 80 patients will be enrolled. All will be enrolled at MD Anderson.

Effects of Meditation on Cognitive Function and Quality of Life

Primary analyses based on difference scores of continuous variables measured at baseline and 8 weeks later. T tests or Wilcoxon two-sample tests used, depending on the distribution of the data. Reliable change index (RCI) used for the cognitive tasks. RCI based on standard error of measurement for each assessment and takes into account baseline levels of performance for any participant. A chi-square test used to compare the proportions of participants that fall into each classification in the meditation and control groups.

M.D. Anderson Cancer Center

Symptoms and General Pathology

Carcinoma

Headache

Pain

Head and Neck Neoplasms

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics, Opioid

Patients participate in CHAT counseling intervention over 45-60 minutes twice a month for up to 12 weeks.

Patients undergo NFB intervention over 20-30 minutes twice a week for up to 10 weeks.

Patients receive 2-3 standard of care sessions per month over 45-60 minutes for up to 12 weeks.

Best Practice

Participate in CHAT counseling intervention

Counseling

Electroencephalography

Neurofeedback

Questionnaire Administration

Sriram Yennu

This phase II trial compares different pain management interventions (standard of care \[SOC\], neurofeedback \[NFB\] training, and compassionate high alert team \[CHAT\]) in patients diagnosed with head and neck cancer who are at risk of developing non-medical opioid use (NMOU). The current standard treatment includes regular clinic visits and supportive care and counseling (including topics like patient-doctor communication, cancer care goals, financial issues counseling, and other topics). NFB training is a type of therapy that uses an electroencephalograph (EEG) and a computer software program to measure brain wave activity. The goal of NFB is to help teach patients with pain how to change their own brain waves to lower their feelings of pain and help improve their quality of life. CHAT is a supportive care intervention that includes symptom and pain management, counseling (about pain, symptoms, opioid use and safety, stress, and quality of life), and support for patients and their family members. NFB and CHAT may help to manage pain and lower patient use of opioids.

PRIMARY OBJECTIVE:

I. To test the hypothesis that this study will be feasible, as defined by adequate rates of adherence in the CHAT and NFB groups.

SECONDARY OBJECTIVES:

I. To examine the frequency of NMOU behaviors at the end of 3 months after CHAT, NFB, and SOC.

II. Examine the pain severity (area under the curve \[AUC\]), daily opioid use AUC of the cumulative morphine equivalent daily dose (MEDD), and mood (Hospital Anxiety and Depression Scale, HADS) for each of the treatment arms (CHAT, NFB, or SOC) in head and neck cancer (HNC) patients receiving radiation therapy at the end of 3 months.

EXPLORATORY OBJECTIVE:

I. To examine the cortical and subcortical regions of the brain associated with pain and our interventions (CHAT, NFB, and SOC) and the extent to which changes in electroencephalogram (EEG) patterns mediate the effects of the intervention.

OUTLINE: Patients are randomized into 1 of 3 arms.

ARM I: Patients participate in CHAT counseling intervention over 45-60 minutes twice a month for up to 12 weeks.

ARM II: Patients undergo NFB intervention over 20-30 minutes twice a week for up to 10 weeks.

ARM III: Patients receive 2-3 standard of care sessions per month over 45-60 minutes for up to 12 weeks.

Interdisciplinary Interventions to Address Pain Management Among Head and Neck Cancer Patients

Opioid-Sparing Interdisciplinary Interventions Addressing Pain in Head and Neck Cancer Patients

Composite NMOU score is calculated by summing the number of times each behavior suggestive of NMOU is recorded.

Recurrence

Patients undergo EEG over 30 minutes daily until death or discharge and complete questionnaires over 30 minutes daily until death or discharge to check level of consciousness, thought, and ability to communicate.

David Hui

This study investigates the use electroencephalography (EEG - a test that measures brain waves) to learn if patients who appear unresponsive (do not respond to noises, words, or touch) retain any consciousness. Families want to know if their loved ones who are unresponsive can still hear them or feel any discomfort. Information gained from this study may have important impact in how patients, caregivers, and doctors make decisions.

PRIMARY OBJECTIVES:

I. To estimate the magnitude of electroencephalography (EEG) response to verbal stimuli among cancer patients in the last days in life admitted to a palliative and supportive care unit (PSCU).

II. To examine the feasibility of conducting EEG in cancer patients in the last days of life.

SECONDARY OBJECTIVES:

I. To compare the magnitude of EEG response between impending death cohort and control cohort.

II. To determine the association between the magnitude of EEG response and clinical assessments (e.g. JFK Coma Recovery Scale-Revised \[CRS-R\], Glasgow Coma Scale \[GCS\], Richmond Agitation Sedation Scale \[RASS\], Memorial Delirium Assessment Scale \[MDAS\]) in impending death cohort and control cohort separately.

III. To determine the magnitude of EEG response to pressure/noxious stimuli in impending death cohort and control cohort separately.

IV. To examine serial EEG changes in auditory cortex activation and cognitive processing in cancer patients over the last days of life.

OUTLINE:

Patients undergo EEG over 30 minutes daily until death or discharge and complete questionnaires over 30 minutes daily until death or discharge to check level of consciousness, thought, and ability to communicate.

Assessment of Verbal Comprehension and Cognitive Processes in Patients Admitted to the Palliative and Supportive Care Unit

Can You Hear Me? Assessment of Verbal Comprehension and Cognitive Processes in Patients in the Last Days of Life

The magnitudes of EEG responses in each task will be calculated as the difference between pre-stimulus and post-stimulus, separately. 95% confidence intervals will be estimated for each task.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Meditation on Cognitive Function and Quality of Life	NCT02162329	Breast Cancer	Questionnaires Electroencephal... Magnetic Resona... Meditation Clas...	35 Years - 65 Years	M.D. Anderson Cancer Center
Interdisciplinary Interventions to Address Pain Management Among Head and Neck Cancer Patients	NCT05077072	Head and Neck C...	Best Practice Counseling Electroencephal... Neurofeedback Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Interdisciplinary Interventions to Address Pain Management Among Head and Neck Cancer Patients	NCT05077072	Head and Neck C...	Best Practice Counseling Electroencephal... Neurofeedback Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Interdisciplinary Interventions to Address Pain Management Among Head and Neck Cancer Patients	NCT05077072	Head and Neck C...	Best Practice Counseling Electroencephal... Neurofeedback Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Effects of Meditation on Cognitive Function and Quality of Life	NCT02162329	Breast Cancer	Questionnaires Electroencephal... Magnetic Resona... Meditation Clas...	35 Years - 65 Years	M.D. Anderson Cancer Center
Interdisciplinary Interventions to Address Pain Management Among Head and Neck Cancer Patients	NCT05077072	Head and Neck C...	Best Practice Counseling Electroencephal... Neurofeedback Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Assessment of Verbal Comprehension and Cognitive Processes in Patients Admitted to the Palliative and Supportive Care Unit	NCT05091632	Hematopoietic a... Locally Advance... Metastatic Mali... Recurrent Malig...	Electroencephal... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for electroencephalography