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

Partner:

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.

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 4-5 sessions (based on your preference)
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/Zoom), depending on your availability. After your first session, all
sessions will be done through video conferences.

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.

During each week, you will also complete a questionnaire on your feelings about the sessions.
You will be asked to 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
meditation outside of class and if you think you are benefitting from the couple-based
mind-body program. It should take about 5 minutes to answer this questionnaire. Your answers
to the questions will not be shared with the patient.

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 12 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, health care, work productivity,
and quality of life. It should take about 55 minutes to complete these questionnaires and can
be completed online or on paper and returned in person or by mail.

You will also complete an additional questionnaire at your first visit, at the end of the
program, and about 3 months after the end of the program. The questionnaire is designed to
test your cognitive abilities (tests to check your memory and thinking abilities, for
example). The questionnaire will take about 15 minutes to complete.

Length of Study:

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

Patient:

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 4-5 sessions (based on your preference)
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/Zoom), 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 12 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, health care, work productivity,
and quality of life. It should take about 55 minutes to complete these questionnaires and can
be completed online or on paper and returned in person or by mail.

You will also complete an additional questionnaire at your first visit, at the end of the
program, and about 3 months after the end of the program. The questionnaire is designed to
test your cognitive abilities (tests to check your memory and thinking abilities, for
example). The questionnaire will take about 15 minutes to complete.

Length of Study:

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

Inclusion Criteria:

1. (Patient Only): Patients with a Diagnosis of HGG or low grade glioma (LGG), based on
radiographic or pathologic diagnosis of grade III or IV listed in the medical records,
or patients with a malignancy that has metastasized to the brain.

2. (Patient Only) Patients must be within 1 month of initiating or having undergone any
type of cancer treatment (i.e., surgery, radiotherapy, chemotherapy)

3. (Patient Only) Karnofsky Performance Status (KPS) of 80 or above

4. (Patients Only) having a spouse/romantic partner (including same-sex) and who is
willing to participate

5. (Patient & Partner) at least 18 years old

6. (Patient & Partner) able to read and speak English

7. (Patient & Partner) able to provide informed consent

8. (Patient & Partner) have access to internet connectivity

Exclusion Criteria:

1. (Patient Only) Regularly (self-defined) participation in psychotherapy or a formal
cancer support group

2. (Patient Only) Cognitive deficits that would impede the completion of self-report
instruments as deemed by the clinical team