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An Online Dyadic Mind-Body Intervention for Glioma Patients and Their Partners

2017-08-10 15:08:21 | BioPortfolio

Summary

The goal of this research study is to learn if a couple-based mind-body program can be used during treatment for brain cancer and to learn the opinion of patients and their partners about the program. A partner must be available and willing to take part in this study with you in order for you to take part in this study.

Researchers also want to learn if and how this program affects your spiritual well-being, sleep difficulties, depressive symptoms, and overall quality of life.

Description

If you agree to take part in this study, your demographic information (such as your age, sex, race/ethnicity, marital status and how long you have been married, and your job and education history) will be collected at your first visit. Additional medical information will be collected from your medical record, such as your current and/or past nicotine use.

After your first visit, you and your partner will be randomly assigned (as in the roll of dice) 1 of 2 groups. This is done because no one knows if one study group is better, the same, or worse than the other.

- If you are in Group 1, you will take part in the couple-based mind-body program.

- If you are in Group 2, you will not take part in the couple-based mind-body program. After the study has been completed, you and your partner will be offered the opportunity to take part in the couple-based mind-body program. This will be offered outside of this study (but will continue to be offered at no cost to you).

You have about an equal chance (50/50) of being assigned to each group.

Group 1 Only - Couple-Based Mind-Body Sessions:

If you are in Group 1, you will take part in up to 4 sessions over the course of 6 weeks. Each session will last about 60 minutes and will be guided by an instructor. You and your caregiver should attend each session together as partners. Your first session will be done face-to-face in person or it can be done through a video conference (FaceTime), depending on your availability. After your first session, all sessions will be done through videoconferencing.

If you do not have a computer or iPad, you will be loaned an iPad while you are on study so you can complete the sessions. You will complete an iPad agreement form and return the iPad on the date that is noted in the agreement. If the iPad is lost, damaged, or stolen, you should tell the study staff right away. You may be asked to file a police report, if it is stolen. You will not be responsible for the cost of replacing the iPad. You will not be able to keep the iPad after the study is over.

During the sessions, you will be asked to do deep-breathing and meditation exercises. The sessions are designed for beginners and should not be difficult. You will sit in a chair while you do the exercises. You can move through the exercises at your own pace. The instructor will be available to answer any questions you may have about the sessions.

The sessions will be audio recorded. This is so the researchers can keep track of the quality of the sessions. Only the study staff will be able to review these recordings. The audio recordings are digital and will be destroyed about 7 years after the end of the study. If you do not allow the sessions to be audio recorded, you cannot take part in this study.

At your first session, you will be given CDs and instructions for practicing meditation at home. You will be asked to practice at home 1 time a day for 5-15 minutes either with your partner or alone on the days you do not have a session with the instructor.

You will also be asked to complete an intentional activity each day. For example, the study staff will ask you and your partner what form of affection you prefer and you should both try and purposefully display that act of affection during the week. So, if you like to hold hands, you should try and hold your partner's hand intentionally/more often.

Each week, you will also complete a questionnaire on your feelings about the 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 practiced meditation outside of class and if you think you are benefitting from the program. It should take about 5 minutes to answer this questionnaire. Your answers to the questions will not be shared with your partner.

You will receive 2 phone calls each week (over about a 6 week period) from the instructor while you are taking part in the sessions. During the phone call, the instructor will make sure you and your partner are able to successfully use the meditation and exercises learned in class on your own and in the context of everyday situations to help manage symptoms that you may have. Each phone call should last about 15 minutes.

Groups 1 and 2 - Questionnaires:

Group 1 and 2 participants will complete these questionnaires. If you are in Group 2, the study staff will tell you when to complete these questionnaires as the timing will match up to the sessions of the Group 1 participants.

You will complete about 10 questionnaires before the first session, after the last session (usually 6 weeks later) and three months after you complete the study. The questionnaires ask about your health, your mood, sleeping habits, relationship, and quality of life. It should take about 45 minutes to complete these questionnaires and can be completed online or on paper and returned in person or by mail.

Length of Study:

Your participation on this study will be over when you have completed the last set of questionnaires.

This is an investigational study.

Up to 50 patients and 50 caregivers (100 total participants) will be enrolled in this study. All will take part at MD Anderson

Study Design

Conditions

Malignant Neoplasms of Eye Brain and Other Parts of Central Nervous System

Intervention

Questionnaires, Mind-Body Intervention, Compact Discs (CD's) + Printed Materials, Phone Calls

Location

University of Texas MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-08-10T15:08:21-0400

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