Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Anti-Inflammatory Agents

All Drugs and Chemicals

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Participants attend a 7-day offsite, residential support program. On Day 5 of the program, participant joined by spouse or caregiver.

Questionnaires completed at baseline visit, 1 month after baseline. EEG performed with simultaneous computer testing. Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.

Questionnaires and testing repeated 7 days after the residential program ends, and then again about 3 months later.

Questionnaires completed at baseline visit, 1 month after baseline. EEG performed with simultaneous computer testing. Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.

Questionnaires and testing repeated 7 days after the residential program ends, and then again about 3 months later.

Participants attend a 7-day offsite, residential support program. On Day 5 of the program, participant joined by spouse or caregiver.

Residential Program

Questionnaires completed about mood, sleep, fatigue, how participant has been feeling, and their general quality of life at baseline visit, 1 month after baseline, 7 days after residential program ends, and again about 3 months later.

Questionnaires

EEG performed at baseline with simultaneous computer testing consisting of 3 tests to check attention, short-term memory, and levels of emotions. EEG repeated 7 days after the residential program ends, and then again about 3 months later.

Electroencephalogram (EEG)

Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. Saliva testing repeated 7 days after the residential program ends, and then again about 3 months later.

Saliva Testing

For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.

Study Diary plus Actigraph

Lorenzo Cohen, PHD

The goal of this behavioral research study is to compare 2 different types of residential group programs to help researchers learn if and how well these groups may help to improve physical and emotional well-being in patients with stage IV breast cancer.

Baseline Visit:

Signing this consent form does not mean that you will be able to take part in this study. The following baseline tests will help the doctor decide if you are eligible:

* You will complete 7 questionnaires about your mood, sleep, fatigue, how you have been feeling, and your general quality of life. The questionnaires should take about 60-80 minutes to complete.
* You will have an electroencephalogram (EEG) to check your brain's electrical activity. During the EEG, a snug cap with 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 the EEG, you will complete 3 tests to check your attention, short-term memory, and levels of emotions on the computer. The study staff will discuss each test in more detail with you. The EEG and tests will take about 45-60 minutes total.
* If you have not had a computed tomography (CT) scan in the last 2 months, you will have one performed to check the status of the disease. If you have had one in the last 2 months, the results will be collected from your medical records.
* You will have an electrocardiogram (EKG) to check your heart function.
* Blood (about 6 tablespoons) will be drawn for tests to measure hormones and your immune system responses. You will need to fast (not eat or drink anything except water) for 12 hours before this blood draw. You will be provided with healthy snacks after your blood draw.

The day after your baseline visit, saliva will be collected to measure the level of cortisol (a type of stress hormone) in your body. These saliva samples will be collected 4 times each day for 3 days in a row. You will collect these samples at home when you first wake up, about 45 minutes later, about 10 hours after waking up, and then at bedtime. To collect each saliva sample, you will chew on a cotton ball for a few seconds and then put the cotton in a small plastic tube. You will write down the times you took these samples. You will mail these samples back to MD Anderson in postage-paid envelopes that will be provided to you. The tubes will also be provided at no cost to you. These saliva samples will be destroyed after being studied.

Every day for the next 7 days after your baseline visit, you will fill out a diary about your sleeping habits. You will also wear a special type of wrist watch for these 7 days. The watch will collect data about your physical activity and sleeping habits. After you have worn it for 7 days, you will mail the watch and the sleep diary back to MD Anderson in postage-paid envelopes that will be provided to you.

Extended Baseline:

You will be asked to complete and provide all the same measures again 1 month after the first baseline visit.

Study Groups:

If you are found to be eligible to take part in this study and you agree, you will be randomly assigned (as in the roll of dice) to 1 of 3 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.

* If you are assigned to Groups 1 or 2, you will take part in 1 of 2 types of residential group programs.
* If you are assigned to Group 3, you will receive standard cancer care without any participation in a residential group program.

If you are assigned to Groups 1 or 2, neither you nor the study staff will know what kind of residential group program you are in.

Residential Support Program Sessions (Groups 1 and 2 only):

You will take part in a 7-day offsite, residential support program in groups of about 10 participants each. On Day 5 of the retreat, you will be joined by your spouse or caregiver.

During the 7 days, you will take part in group activities, learn relaxation skills, do different cognitive activities (for example, reading, watching movies, and having group discussions), and learn about mind-body connections. You will spend 7 days and 6 nights at the residential retreat. Activities at the retreat will last about 12 hours per day with breaks, group meals, and free time to rest in the morning, afternoon and evening, or as needed.

At least 1 week before the retreat, you will be given a detailed agenda and schedule of all activities that will occur during the retreat.

Follow-Up Sessions (All Groups):

You will complete the same tests/procedures that were performed at the baseline visit within 7 days after the residential program ends and then again about 3 months later. If you are in Group 3, you will complete the same tests/procedures on the same schedule.

Length of Participation:

Your participation on this study will be over after you complete the follow-up sessions.

Depending on which study group you were assigned to, you may be able to take part in a residential program that you did NOT previously take part in. The study chair or research staff will discuss this option with you.

This is an investigational study.

Up to 100 participants and their caregivers will take part in this multicenter study. Up to 74 will be enrolled at MD Anderson.

Effects of a Group Residential Retreat on Cancer Outcomes

Participant compliance with assessments monitored as well as participation in all aspects of the intervention program. Intervention deemed feasible if ≥ 60% of enrolled couples complete all assessments and attend the assigned retreat.

M.D. Anderson Cancer Center

Symptoms and General Pathology

Nervous System Diseases

Behaviors and Mental Disorders

Fatigue

Parasomnias

Dyssomnias

Quality of Life

Simple stretching exercises, specific breathing skills, and guided relaxation for 3 sessions, 3 times a week for 6 weeks. Each session should last about 60 minutes. Multiple questionnaires taken before, during and after radiotherapy/exercise intervention programs during course of study. 4 saliva samples per day for cortisol testing for 3 days before radiation therapy begins, for 3 days in the last week of radiation therapy, for 3 days in a row 3 months after radiation therapy ended, for 3 days in a row, for 6 months after radiation therapy ended, and for 12 months after radiation therapy ended.

Participants in this group given the option to take part in one of the two forms of relaxation (off study) after they finish their last questionnaire packet. 4 saliva samples per day for cortisol testing for 3 days before radiation therapy begins, for 3 days in the last week of radiation therapy, for 3 days in a row 3 months after radiation therapy ended, for 3 days in a row, for 6 months after radiation therapy ended, and for 12 months after radiation therapy ended.

3 times a week, 60 minute sessions for 6 weeks.

Relaxation Program

Multiple questionnaires taken before, during and after radiotherapy/exercise intervention programs during course of study.

4 saliva samples per day for cortisol testing for 3 days before radiation therapy begins, for 3 days in the last week of radiation therapy, for 3 days in a row 3 months after radiation therapy ended, for 3 days in a row, for 6 months after radiation therapy ended, and for 12 months after radiation therapy ended.

The goal of this behavioral research study is to compare two different forms of relaxation programs that will include stretching and relaxation techniques, in order to learn if and how well they may help to improve physical and emotional well-being. This will be tested in patients with breast cancer who are receiving radiation therapy. For comparison purposes, there will also be a group of participants that does not take part in the relaxation programs.

This is an investigational study. The relaxation programs are being compared for research purposes only.

An "assessment" is any time you complete a set of scheduled activities for this study, such as tests and questionnaires.

Up to 700 patients will take part in this study. All will be enrolled at MD Anderson.

During the first visit, you will fill out questionnaires that ask about your sleeping habits, how you have been feeling, and the general quality of your life. This should take about 60-80 minutes.

Every day for the next 7 days, you will fill out a diary about your sleep. You will also wear an "actigraph" wrist watch 24 hours a day for these 7 days. The watch will collect data about your physical activity and sleeping habits.

You will also have an electrocardiogram (ECG - a test to measure the electrical activity of your heart) which will last about 10 minutes.

Study Groups:

After your first visit, you will be randomly assigned (as in the roll of dice) to 1 of 3 groups:

* Group 1 will take part in one type of relaxation program.
* Group 2 will take part in another type of relaxation program.
* Group 3 will not take part in either program but will complete some of the follow-up procedures. Participants in this group will be given the option to take part in one of the two forms of relaxation (off study) after they finish their last questionnaire packet.

You will have about a 1 out of 3 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.

Sessions:

Groups 1 and 2:

You will take part in 3 sessions each week for the 6 weeks of radiation therapy, or 4-5 sessions each week for 4 weeks if your radiation therapy lasts only 4 weeks. You can choose any weekday (Monday through Friday). Each session should last about 60 minutes.

The sessions will be taught by an experienced, trained instructor, usually in groups of 2-5 participants. The movements are designed to be easy to follow. You will be able to work at your own pace.

Each session will be audio and video recorded. 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.

Women in Groups 1 and 2 will be randomized to a maintenance intervention arm or a usual contact arm after the end of radiotherapy. If you are randomized to the maintenance intervention arm you will receive telephone counseling once a month after the end of your radiotherapy. You will also receive booster sessions once every 3 months post-radiotherapy, or at least when you come for your follow-up appointments.

Groups 1 and 2:

During the sessions, you will do simple stretching exercises, specific breathing skills, and guided relaxation. You will be asked to try and practice once a day for 12 months. You will be provided a DVD and an audio CD to help with your practice when you are not at the hospital.

Questionnaires and Study Procedures:

Groups 1 and 2:

Before your first session of the week except for week 1, Groups 1 and 2 will fill out a questionnaire about the relaxation program. This should take about 1-2 minutes.

During the middle of your radiation treatment period, you will have an ECG recorded before and after your classes. Each ECG will last about 10 minutes.

All Groups:

During the middle of your radiation treatment period, you will fill out a questionnaire that asks about any symptoms you may be having. This should take about 15 minutes. You will also have an ECG.

During your last week of radiation therapy, and at 3, 6, and 12 months after your radiation therapy ends, you will fill out a set of questionnaires. The questionnaires will be mostly the same as at your first study visit. This should take about 60-80 minutes. You will also have an ECG at these times.

Questionnaire packets will be mailed to your home by the research staff. After completing the questionnaires, you will return the completed questionnaire packet to the research staff via a pre-paid mailing envelope.

Every day for 7 days in a row, after every time you fill out the questionnaires, you will fill out another sleep diary. During these 7-day periods, you will wear an actigraph watch 24 hours a day to collect the same data as before. Each time, you will mail the actigraph watch back to MD Anderson in postage-paid envelopes that will be provided to you.

If your questionnaire responses show that you may be having emotional difficulties or depression, you will be provided with names of mental health providers in case you would like to receive mental health screening.

All participants will be asked not to do any other stretching/relaxation practices during the study.

Saliva Testing:

You will provide 4 saliva samples per day for cortisol testing on the following schedule:

* for 3 days before radiation therapy begins
* for 3 days in the last week of radiation therapy
* for 3 days in a row, 3 months after radiation therapy ended
* for 3 days in a row, 6 months after radiation therapy ended
* for 3 days in a row, 12 months after radiation therapy ended

To provide a saliva sample, you will chew on a cotton ball for a few seconds and then put the cotton in a small plastic tube. You will then mail the samples back to MD Anderson in postage-paid envelopes that will be provided to you. The tubes will also be provided at no cost to you. These saliva samples will be destroyed after being studied.

Length of Participation:

Your study participation will be over after you fill out the questionnaires 12 months after radiation therapy.

Relaxation for Women With Breast Cancer Undergoing Radiotherapy

Biobehavioral Effects of Relaxation for Women With Breast Cancer Undergoing Radiotherapy

Effectiveness of 6-week relaxation intervention evaluated by physical component scale scores during and after treatment, defined as Medical Outcomes Study 36-item short-form survey (SF-36).

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Infections

Communicable Diseases

Epstein-Barr Virus Infections

Virus Diseases

Disease Attributes

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Saliva EBV-DNA Detection comparing with PBMC and plasma EBV-DNA

Zhao Wang, Dr

Yue Song, M.M.

Zhao Wang

This study is a single-center, prospective, observational clinical study to evaluate the Application of saliva EBV-DNA Detection in EBV Infection Related Diseases

Study on the Application of Saliva EBV-DNA Detection in EBV Infection Related Diseases

A Prospective Study on the Application of Saliva EBV-DNA Detection in EBV Infection Related Diseases

The sensitivity and specificity of saliva EBV-DNA detection level as a diagnosis for EBV infection-related diseases, and whether it can replace peripheral blood EBV-DNA monitoring

The sensitivity and specificity of saliva EBV-DNA detection level as a monitoring method for EBV infection-related diseases, and whether it can replace peripheral blood EBV-DNA monitoring

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of a Group Residential Retreat on Cancer Outcomes	NCT02429544	Breast Cancer	Residential Pro... Questionnaires Electroencephal... Saliva Testing Study Diary plu...	50 Years -	M.D. Anderson Cancer Center
Relaxation for Women With Breast Cancer Undergoing Radiotherapy	NCT01202851	Breast Cancer	Relaxation Prog... Questionnaires Saliva Testing	18 Years -	M.D. Anderson Cancer Center
Effects of a Group Residential Retreat on Cancer Outcomes	NCT02429544	Breast Cancer	Residential Pro... Questionnaires Electroencephal... Saliva Testing Study Diary plu...	50 Years -	M.D. Anderson Cancer Center
Study on the Application of Saliva EBV-DNA Detection in EBV Infection Related Diseases	NCT04782674	EBV Infection	Saliva Testing	3 Years - 65 Years	Beijing Friendship Hospital

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