Self-Administered Meditation Intervention for Cancer Patients With Psychosocial Distress

Baseline Visit:

You have already had assessments as part of your routine care that helped show that you were
eligible to take part in this study. If you agree to take part in this study, the following
tests and procedures will be performed at your first study visit:

- Your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be
measured.

- Your medical history will be collected.

- You will be asked about any drugs you may be taking and any side effects you may be
having.

- You will complete a questionnaire about how you feel about meditation. This
questionnaire should take about 5 minutes to complete.

- You will complete a basic demographic information (ethnicity, gender, age, and so on)
questionnaire. This questionnaire should take about 5 minutes to complete.

- You will complete 4 questionnaires about any symptoms you may have. The questionnaires
should take about 15-20 minutes total to complete.

Study Groups:

After the baseline visit has been completed, you will be randomly assigned (as in the toss of
a coin) to 1 of 2 study groups.

- If you are enrolled in Group 1, you will be given access to a computer-based meditation
program for 2 weeks.

- If you are enrolled in Group 2, you will be in the control group and will receive access
to social workers, support groups, spiritual care, and other patient services.

Meditation Group (Group 1):

If you are in Group 1, you will be given an iPod that has the meditation app already
installed on it. You will complete an iPod agreement form and return the iPod on the date
that is noted in the agreement. If the device is lost, damaged, or stolen please tell the
research staff as soon as possible. If the device is stolen, please file a police report. A
copy of this report need to be shared with the study coordinator.

On your first day, you will watch a pre-recorded video in the app that tells you about the
practice of meditation and what to expect during meditation (for example, you will do deep
breathing and visualization exercises). You will return the device at the end of your
participation.

You will be encouraged to meditate at least 1 time every day for up to 2 weeks using the
meditation app. You will be able to set a reminders for yourself through the meditation app.

Each day, you will open the app and select a 5-, 10-, or 15-minute long meditation session
that you will follow along with. You will complete a questionnaire about your mood before and
after each meditation session through the app which will take less than 1 minute to complete
each time.

The app will track how many times you meditate each day, how long you meditate for, and when
you meditate. This information, including your mood questionnaire responses, will be sent to
the study staff.

Control Group (Group 2):

If you are assigned to the waitlist control group you will not receive the meditation app for
the first 2 weeks. You will have access to your doctor as well as access to social workers,
support groups, spiritual care, and other patient services.

All Participants:

At the end of the study period, all participants may have permanent access to the meditation
guidance recordings (audio files only), if requested.

Length of Study:

Your participation on this study will last up to 2 weeks.You will no longer be able to take
part in meditation if your symptoms gets worse or if you are unable to follow study
directions.

Your participation in this study will be over after you have completed the end-of-study
visit.

End-of-Study:

After you have completed the meditation program for Group 1 or after 2 weeks for Group 2:

- Your vital signs will be measured.

- Your medical history will be recorded.

- You will be asked about any drugs you may be taking and any side effects you may be
having.

- You will complete the same 4 questionnaires that you completed at screening.

- You will have an interview with a member of the study staff. You will be asked questions
about your opinions on meditation and if you think you benefitted from meditation. This
interview should take about 10 minutes to complete.

Inclusion Criteria:

1. Patients at MD Anderson with a cancer history who are either undergoing active
treatment or who have completed treatment for their cancer.

2. Must understand and read English, sign a written informed consent, and follow protocol
requirements.

3. Age >/= 18 years willing to come to MD Anderson Main Campus (Texas Medical Center) for
enrollment.

4. Patient self-reported ESAS psychological scale score (sum of anxiety and depression
scores) between 4 and 11 (and/or) individual anxiety or depression score between 4 and
7 on a 0 to 10 numeric scale, where 10 is the worst possible.

5. If on medication for anxiety, stable dose of medications for management of anxiety
symptoms for at least six weeks prior to enrollment with no plans to change
meditations in the subsequent four weeks. Increases or decreases allowed within drug
class, but changing drug class will make patient in-evaluable.

Exclusion Criteria:

1. Diagnosis of a formal thought disorder (e.g., schizophrenia).

2. Known history of a neurological and/or psychological disorder that in the physician's
opinion may interfere with the patient's ability to cooperate with study procedures.