Mindfulness Based Couples Therapy

Baseline Visit:

If you are found to be eligible to take part in this research study, you will return to the
clinic about a week later for the Baseline Visit. You will be instructed to fast (eat nothing
and drink only water) for at least 8 hours before this visit.

- Blood (about 4-5 tablespoons) will be drawn for tests of your immune function, stress
hormone levels, and blood sugar levels. After this blood test, you will be given
breakfast.

- You will complete a pain assessment which involves you submerging your hand in cold
water. Researchers will use your response to measure your pain tolerance.

- You will have electrocardiograms (EKGs) to check your heart function. The sensors will
be attached at the beginning of the visit and then removed before you leave. You will be
attached to the machine for several hours, but you will be able to be disconnected to
take bathroom breaks, if needed.

- You will complete questionnaires about fatigue, mood, stress, social support, marital
satisfaction, depression, and general demographics (age, race and so on). It should take
about 1½ hours total to complete the questionnaires.

- You will complete a series of traditional neurocognitive tests (for example, tests to
check your memory and thinking abilities). You will take these tests on the computer and
with a pen and paper.

- Your blood pressure will be measured multiple times throughout the visit.

Study Groups and Interventions:

After the Baseline visit, you will be assigned to one of 2 groups. If you are in Group 1, you
and your partner will take part in an 8-week Mindfulness-Based Relationship Enhancement
(MBRE) intervention course designed to alleviate stress and other symptoms among couples. The
MBRE course will consist of eight sessions taught by a professional Mindfulness instructor.
The sessions will occur 1 time a week and last about 2½ hours each time. The MBRE course will
consist of meditation and yoga techniques and handouts. The sessions will focus on teaching
participants (all female breast cancer survivors and partners) the basics of Mindfulness
Based Relationship Enhancement.

Attendance at these sessions and completion of daily homework assignments requiring up to 45
minutes per day are essential to the program.

If you are in Group 2, you will receive self-help materials that have been previously
developed by MD Anderson's Office of Public Education, the American Cancer Society, and the
National Cancer Institute.

Post-Intervention Follow-Up Visit:

If you are in Group 1, you will have a post-intervention follow-up visit about 12 weeks after
your Baseline visit (4 weeks after you finish your 8-week intervention sessions). If you are
in Group 2, you will have a post-intervention follow-up visit about 8 weeks after the
Baseline Visit. You will fast for 8 hours before a post-intervention follow-up visit.

- Blood (about 4 to 5 tablespoons) will be drawn to check your immune function, stress
hormone levels, and blood sugar. After the blood is drawn you will be given breakfast.

- You will complete the cold water pain tolerance test.

- You will have electrocardiograms (EKGs).

- You will complete questionnaires about fatigue, mood, stress, social support, marital
satisfaction, depression, and general demographics (age, race and so on). It should take
about 1½ hours total to complete the questionnaires.

- You will complete a series of traditional neurocognitive tests.

- Your blood pressure will be measured multiple times throughout the visit.

Cortisol Testing:

After the Baseline and Follow-up Visits, you will be asked to give samples to measure
cortisol, a hormone related to stress. You will place a small cotton tube in your mouth for
about 2 minutes, or until the swab is completely soaked with your saliva. After this, you
will place the swab back in the tube, and freeze the sample. You will be given containers to
hold the samples when you freeze them, as well as to mark which day and time each sample was
collected. You will take these samples 7 times a day (right when you wake up; about 30, 45,
and 60 minutes after waking; and then at noon, 4:00 p.m., and 8:00 p.m.). Researchers will
use these samples to measure the changes in cortisol throughout the day. You will collect
these samples for 2 days during the week, and 2 days on the weekend. After you complete 4
total days of collecting saliva samples after each visit, you will mail them back to MD
Anderson in pre-paid envelopes.

Program Satisfaction Evaluations:

After the follow-up visits, the study staff will conduct individual interviews with a small
group of participants. Interview questions will address participants' overall reactions to
and satisfaction with the mind-body intervention, the impact they felt from social support,
motivation, and their own ability for increasing physical activity and well-being. The study
staff will also ask questions about both positive and negative effects of participating in
the intervention. Interviews will be conducted by the PI or a trained research coordinator.
All interviews will last no longer than 90 minutes and will be audio-taped using a digital
recorder and transcribed. All audio files will be destroyed after they are transcribed.

This is an investigational study.

Up to 30 couples (60 participants) will take part in this research study. All will be
enrolled at MD Anderson.

Inclusion Criteria:

1. Stage 0-IIIA breast cancer survivors and their partner

2. All the female breast cancer survivors will be at least two months from receiving
cancer treatment (surgery, adjuvant therapy or radiation) and within three years from
completing cancer treatment, except for tamoxifen/aromatase inhibitors.

3. Are able to read and write in English

4. Are able to pass the Physical Activity Readiness Questionnaire or participant provides
a letter from their physician or nurse practitioner clearing them for study
participation

5. All couples co-habiting for at least 3 years with current partner who is willing to
participate in study

6. Are 21 years of age or older

Exclusion Criteria:

1. Male breast cancer survivors;

2. Participants with a diagnosis of diabetes, unless they are able to provide a letter
from a physician who will continue to monitor the participant during the research
study

3. Anti-inflammatory medications (e.g. statins, cholesterol medication)

4. Consume excessive amounts of alcohol (>30 drinks/week)

5. Pregnant or thinking about becoming pregnant during the study period

6. Lactating women

7. Major medical conditions involving the immune system such as autoimmune and/or
inflammatory diseases

8. Pressure readings >/=140/90 mm Hg, as defined by the 7th Report of the Joint National
Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure,
will be deemed ineligible to participate and excluded from the study. They will be
referred to their family physician or community services. Those ineligible based on
their initial blood pressure reading are allowed to participate if they provide a
letter from a physician who will continue to monitor the participant during the
research study.

9. A hemoglobin level < 10g/dl

10. Person less than 21 years of age