Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Pain

Breast Diseases

Skin Diseases

Anti-Inflammatory Agents

All Drugs and Chemicals

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Participant and partner take part in an 8-week Mindfulness-Based Relationship Enhancement (MBRE) intervention course. MBRE course consists of meditation and yoga techniques and handouts.

Pain assessment administered at baseline and at follow up visit. Questionnaires completed at baseline and at follow up visit. Neurocognitive tests administered at baseline and at follow up visit. Cortisol testing performed after baseline visit and at follow up visit. Interviews conducted after follow up visit. These interviews are audio-taped and transcribed.

Participants receive self-help materials that have been previously developed by MD Anderson's Office of Public Education, the American Cancer Society, and the National Cancer Institute.

Pain assessment administered at baseline and at follow up visit. Questionnaires completed at baseline and at follow up visit. Neurocognitive tests administered at baseline and at follow up visit. Cortisol testing performed after baseline visit and at follow up visit. Interviews conducted after follow up visit. These interviews are audio-taped and transcribed.

Participant and partner take part in an 8-week Mindfulness-Based Relationship Enhancement (MBRE) intervention course. MBRE course consists of meditation and yoga techniques and handouts.

Mindfulness-Based Relationship Enhancement (MBRE)

Participants and partner receive self-help materials.

Self-Help Materials

Pain assessment administered at baseline and at follow up visit. Pain assessment involves submerging hand in cold water.

Pain Assessment

Questionnaires completed at baseline and at follow up visit. Questionnaires ask about fatigue, mood, stress, social support, marital satisfaction, depression, and general demographics (age, race and so on). It should take about 1½ hours total to complete the questionnaires.

Questionnaires

Neurocognitive tests administered at baseline and at follow up visit. Tests to check memory and thinking abilities.

Neurocognitive Tests

Cortisol testing performed after baseline visit and at follow up visit. Participants asked to collect saliva samples for cortisol assays immediately, 30, 45, and 60 minutes after awakening (representing the cortisol awakening response) and at noon, 4 P.M. and 8 P.M.

Cortisol Tests

Interviews conducted after follow up visit. These interviews are audio-taped and transcribed.

Interviews

Robert Dantzer, PHD

The goal of this study is to explore the effects of a Mindfulness Based Couples Intervention on relationship satisfaction with quality of life and immune system function among breast cancer survivors and their partners.

Baseline Visit:

If you are found to be eligible to take part in this research study, you will return to the clinic about a week later for the Baseline Visit. You will be instructed to fast (eat nothing and drink only water) for at least 8 hours before this visit.

* Blood (about 4-5 tablespoons) will be drawn for tests of your immune function, stress hormone levels, and blood sugar levels. After this blood test, you will be given breakfast.
* You will complete a pain assessment which involves you submerging your hand in cold water. Researchers will use your response to measure your pain tolerance.
* You will have electrocardiograms (EKGs) to check your heart function. The sensors will be attached at the beginning of the visit and then removed before you leave. You will be attached to the machine for several hours, but you will be able to be disconnected to take bathroom breaks, if needed.
* You will complete questionnaires about fatigue, mood, stress, social support, marital satisfaction, depression, and general demographics (age, race and so on). It should take about 1½ hours total to complete the questionnaires.
* You will complete a series of traditional neurocognitive tests (for example, tests to check your memory and thinking abilities). You will take these tests on the computer and with a pen and paper.
* Your blood pressure will be measured multiple times throughout the visit.

Study Groups and Interventions:

After the Baseline visit, you will be assigned to one of 2 groups. If you are in Group 1, you and your partner will take part in an 8-week Mindfulness-Based Relationship Enhancement (MBRE) intervention course designed to alleviate stress and other symptoms among couples. The MBRE course will consist of eight sessions taught by a professional Mindfulness instructor. The sessions will occur 1 time a week and last about 2½ hours each time. The MBRE course will consist of meditation and yoga techniques and handouts. The sessions will focus on teaching participants (all female breast cancer survivors and partners) the basics of Mindfulness Based Relationship Enhancement.

Attendance at these sessions and completion of daily homework assignments requiring up to 45 minutes per day are essential to the program.

If you are in Group 2, you will receive self-help materials that have been previously developed by MD Anderson's Office of Public Education, the American Cancer Society, and the National Cancer Institute.

Post-Intervention Follow-Up Visit:

If you are in Group 1, you will have a post-intervention follow-up visit about 12 weeks after your Baseline visit (4 weeks after you finish your 8-week intervention sessions). If you are in Group 2, you will have a post-intervention follow-up visit about 8 weeks after the Baseline Visit. You will fast for 8 hours before a post-intervention follow-up visit.

* Blood (about 4 to 5 tablespoons) will be drawn to check your immune function, stress hormone levels, and blood sugar. After the blood is drawn you will be given breakfast.
* You will complete the cold water pain tolerance test.
* You will have electrocardiograms (EKGs).
* You will complete questionnaires about fatigue, mood, stress, social support, marital satisfaction, depression, and general demographics (age, race and so on). It should take about 1½ hours total to complete the questionnaires.
* You will complete a series of traditional neurocognitive tests.
* Your blood pressure will be measured multiple times throughout the visit.

Cortisol Testing:

After the Baseline and Follow-up Visits, you will be asked to give samples to measure cortisol, a hormone related to stress. You will place a small cotton tube in your mouth for about 2 minutes, or until the swab is completely soaked with your saliva. After this, you will place the swab back in the tube, and freeze the sample. You will be given containers to hold the samples when you freeze them, as well as to mark which day and time each sample was collected. You will take these samples 7 times a day (right when you wake up; about 30, 45, and 60 minutes after waking; and then at noon, 4:00 p.m., and 8:00 p.m.). Researchers will use these samples to measure the changes in cortisol throughout the day. You will collect these samples for 2 days during the week, and 2 days on the weekend. After you complete 4 total days of collecting saliva samples after each visit, you will mail them back to MD Anderson in pre-paid envelopes.

Program Satisfaction Evaluations:

After the follow-up visits, the study staff will conduct individual interviews with a small group of participants. Interview questions will address participants' overall reactions to and satisfaction with the mind-body intervention, the impact they felt from social support, motivation, and their own ability for increasing physical activity and well-being. The study staff will also ask questions about both positive and negative effects of participating in the intervention. Interviews will be conducted by the PI or a trained research coordinator. All interviews will last no longer than 90 minutes and will be audio-taped using a digital recorder and transcribed. All audio files will be destroyed after they are transcribed.

This is an investigational study.

Up to 30 couples (60 participants) will take part in this research study. All will be enrolled at MD Anderson.

Mindfulness Based Couples Therapy

Mindfulness Based Couples Therapy for Breast Cancer Survivors: A Pilot Study

Feasibility endpoint is intervention adherence rate, defined as the proportion of sessions completed out of a total of 8 sessions.

M.D. Anderson Cancer Center

Head and Neck Neoplasms

Anti-Infective Agents

Central Nervous System Depressants

Ethanol

The performance-based measures will be administered with a total completion time estimated to be 90 minutes. The neurocognitive battery is similar in content and duration to multiple previous and ongoing studies being conducted by the Neurocognitive Research Lab.

Baseline only: WRAT Reading Test, WMS-IV Logical Memory Subtest, Hopkins Verbal Learning Test (HVLT), Oral Trailmaking - Part A and B, NAB Digit Span, Category Fluency Test, Oral Symbol Digit Modalities Test, Brief Test of Attention, FAS - Controlled Oral Word Association Test (COWAT), Verbal Naming, Enformia Cogsuite Battery

Sociodemographics, Computerized Cognitive Training Programs Questionnaire, CDC Behavioral Risk Factor (Smoking Assessment), Alcohol Consumption CDC, Current Health Rating (KPS), OARS Physical Health section, COVID Medical History, Hospital Anxiety and Depression Scale (HADS), Fatigue Symptom Inventory (FSI), Functional Assessment of Cancer Therapy-General (FACT-G V4), Functional Assessment of Cancer Therapy-Cognition (FACT-Cog V3), Sensory Gating Inventory (SGI)

Jonine Bernstein, PhD

The researchers are doing this study to collect more information about if, and how, neurocognitive function may be affected in people being treated with radiation therapy for head and neck cancer. Part of this study is to see if patients diagnosed with head and neck cancer who are undergoing radiation therapy are able to complete neurocognitive testing and questionnaires at 3 times over a period of 1 year.

A Study of Neurocognitive Tests and Questionnaires for People With Head and Neck Cancer Who Are Undergoing Radiation Therapy

Pilot Study of Radiation-Associated Neurocognitive Function Among Head and Neck Cancer Patients

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Memorial Sloan Kettering Cancer Center

Behaviors and Mental Disorders

Rare Diseases

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Quality of Life

Neuroepithelioma

Herbal and Botanical

neurocognitive tests

Marie-Pierre SUNYACH, MD

This is a multicenter prospective study:2 independant cohorts of patients with OMS grade II glioma will be followed during 5 years.

* cohort A: patients in first-line treatment (surgery, radiotherapy or chemotherapy)
* cohort B: patients with disease simple monitoring.

The primary endpoint is to evaluate the impact of tumor and treatments on neurocognitive functions and quality of life, using validate and standard tests.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mindfulness Based Couples Therapy	NCT02349217	Breast Cancer	Mindfulness-Bas... Self-Help Mater... Pain Assessment Questionnaires Neurocognitive ... Cortisol Tests Interviews	21 Years -	M.D. Anderson Cancer Center
A Study of Neurocognitive Tests and Questionnaires for People With Head and Neck Cancer Who Are Undergoing Radiation Therapy	NCT05207098	Head and Neck C...	Neurocognitive ... Questionnaires	18 Years - 89 Years	Memorial Sloan Kettering Cancer Center
Tumor and Treatments Impact on Neurocognitive Functions and Quality of Life of Patients With OMS Grade II Glioma	NCT01305122	OMS Grade II Gl...	neurocognitive ...	18 Years -	Centre Leon Berard
Tumor and Treatments Impact on Neurocognitive Functions and Quality of Life of Patients With OMS Grade II Glioma	NCT01305122	OMS Grade II Gl...	neurocognitive ...	18 Years -	Centre Leon Berard
Mindfulness Based Couples Therapy	NCT02349217	Breast Cancer	Mindfulness-Bas... Self-Help Mater... Pain Assessment Questionnaires Neurocognitive ... Cortisol Tests Interviews	21 Years -	M.D. Anderson Cancer Center

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