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Houston, Texas 77030


Purpose:

The goal of this research study is to learn what patients and their caregivers think about a couple-based Hatha yoga program during treatment for cancer. Researchers also want to learn how this program may affect fatigue, distress, sleep quality, and quality of life. Some patients and caregivers in this study will take part in a Hatha yoga program together. For comparison purposes, there will also be a group of participants that does not take part in this program.


Study summary:

Caregivers: If you agree to take part in this study, your demographic information (such as your age, sex, and race) will be recorded. You and the patient will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You and the patient will have about a 50/50 chance of being assigned to each group. The first five couples recruited will be assigned to the yoga group. Then subsequent groups will be randomly assigned, but your assignment is also based on other factors such as your age and the status of the disease. Group 1 will take part in the couple-based Hatha yoga program. Group 2 will not take part in the couple-based Hatha yoga program but will complete the same questionnaires as Group 1. Participants in this group will be given the option to take part in the couple-based Hatha yoga program (off study) after they finish their last questionnaire packet. Group 1 Hatha Yoga Sessions: If you are in Group 1, you will take part in up to 15 sessions of Hatha yoga at MD Anderson Cancer Center over the course of radiation therapy (up to 5 weekly sessions based on the patient's schedule for usually 5-6 weeks). Each 45- to 60-minute session will be guided by an instructor. You and the patient should attend each session together. During the yoga sessions, you will do deep-breathing exercises and perform different stretching and movement exercises. The movements are designed not to be difficult, and you will sit on the floor or in a chair while you do them. You can move through the exercises at your own pace. The instructor will be available to answer any questions you may have about the practice of Hatha yoga. Most of the yoga sessions may be videotaped. This is so the researchers can keep track of the quality of the sessions. Only the study staff will be able to view the videotapes. The video files are digital and will be deleted after all the data are studied. At your fifth session, you will be given a CD and instructions for practicing Hatha yoga at home. While the patient is receiving radiation therapy, you will be asked to practice at home 1 time each day either with him/her or alone on the days you do not have a session at the clinic. During each week of radiation therapy, you will also complete a questionnaire about the Hatha yoga sessions. You will list what you liked or disliked, what you found most and least useful, and how you would rate the instructor. You will also be asked about how often you practice outside of class and if you think you are benefitting from the Hatha yoga program. It should take about 5 minutes to answer this questionnaire. None of your answers to the questions on the questionnaires will be shared with the patient. Questionnaires for Groups 1 and 2: You will complete about 8 questionnaires before or during the patient's first week of radiation treatment and again at the end of the treatment schedule (usually 6 weeks later). The questionnaires ask about your mood, your quality of life, your feelings about being a caregiver, and your relationship. It should take about 45 minutes to complete these questionnaires. If your questionnaire responses show that you may be having emotional difficulties, depression, or risk of harm to yourself and the study staff thinks it is needed, you will be contacted by a psychologist at MD Anderson. The same would be done if you show signs of emotional distress during a study visit. If the psychologist thinks it is needed, you may be seen by a mental health doctor at MD Anderson. Length of Study: Your participation on this study will be over when you have completed the questionnaires at the time of the patient's end of treatment. If he or she stops radiation therapy early, your study participation will end at that time. This is an investigational study. Up to 40 patients and their caregivers, for a total of up to 80 participants, will be enrolled in this study. All will take part at MD Anderson. Patients: If you agree to take part in this study, your medical history and demographic information (such as your age, sex, and race) will be recorded. Your caregiver will also be approached to take part in this study. After your first visit, you and your caregiver will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You and your caregiver will have about a 50/50 chance of being assigned to each group. The first five couples recruited will be assigned to the yoga group. Then subsequent groups will be randomly assigned, but your assignment is also based on other factors such as your age and the status of the disease. Group 1 will take part in the couple-based Hatha yoga program. Group 2 will not take part in the couple-based Hatha yoga program but will complete the same questionnaires as Group 1. Participants in this group will be given the option to take part in the couple-based Hatha yoga program (off study) after they finish their last questionnaire packet. Group 1 Hatha Yoga Sessions: If you are in Group 1, you will take part in up to 15 sessions of Hatha yoga at MD Anderson Cancer Center over the course of radiation therapy (up to 5 weekly sessions based on your schedule for usually 5-6 weeks). Each 45- to 60-minute session will be guided by an instructor. You and your caregiver should attend each session together. During the yoga sessions, you will do deep-breathing exercises and perform different stretching and movement exercises. The movements are designed not to be difficult, and you will sit on the floor or in a chair while you do them. You can move through the exercises at your own pace. The instructor will be available to answer any questions you may have about the practice of Hatha yoga. Most of the yoga sessions may be videotaped. This is so the researchers can keep track of the quality of the sessions. Only the study staff will be able to view the videotapes. The video files are digital and will be deleted after all the data are studied. At your fifth session, you will be given a CD and instructions for practicing Hatha yoga at home. While you are receiving radiation therapy, you will be asked to practice at home 1 time each day either with your caregiver or alone on the days you do not have a session at the clinic. During each week of radiation therapy, you will also complete a questionnaire about the Hatha yoga sessions. You will list what you liked or disliked, what you found most and least useful, and how you would rate the instructor. You will also be asked about how often you practice outside of class and if you think you are benefitting from the Hatha yoga program. It should take about 5 minutes to answer this questionnaire. None of your answers to the questions on the questionnaires will be shared with your caregiver. Questionnaires for Groups 1 and 2: You will complete about 9 questionnaires before or within your first week of radiation treatment and again after you complete your treatment schedule (usually 6 weeks later). The questionnaires ask about your health, any symptoms you may be having, your mood, your level of fatigue, your sleeping habits, your relationship, and your quality of life. It should take about 45 minutes to complete these questionnaires. If your questionnaire responses show that you may be having emotional difficulties, depression, or risk of harm to yourself and the study staff thinks it is needed, you will be contacted by a psychologist at MD Anderson. The same would be done if you show signs of emotional distress during a study visit. If the psychologist thinks it is needed, you may be seen by a mental health doctor at MD Anderson. Length of Study: Your participation on this study will be over when you have completed the questionnaires at the end of your radiation treatment. If you stop radiation therapy early, your study participation will end at that time. This is an investigational study. Up to 40 patients and their caregivers, for a total of 80 participants, will be enrolled in this study. All will take part at MD Anderson.


Criteria:

Inclusion Criteria: 1. At least 18 years old 2. Able to read and speak English 3. Able to provide informed consent 4. PATIENTS ONLY: Diagnosed with a primary glioma and going to receive at least 4 weeks of radiotherapy with at least 20 fractions. 5. PATIENTS ONLY: Karnofsky Performance Status (KPS) of 80 or above 6. PATIENTS ONLY: Having an informal caregiver (spouse, romantic partner, adult child, sibling, or friend) who is willing to participate. If patients do not have one consistent primary caregiver for the duration of the study, they may be accompanied to the yoga sessions by an alternate caregiver who meets eligibility criteria. Exclusion Criteria: 1. PATIENTS ONLY: Regularly (self-defined) participated in a yoga practice in the year prior to diagnosis 2. PATIENTS ONLY: Physician-rated life expectancy of less than 6 months 3. PATIENTS ONLY: Cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team


NCT ID:

NCT02481349


Primary Contact:

Principal Investigator
Kathrin Milbury, PHD, MA
M.D. Anderson Cancer Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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