About the Study

As more people survive cancer, the importance of research on effective interventions for improving quality of life amongst survivors is growing. Two interventions with a substantial evidence-base are Mindfulness-Based Cancer Recovery (MBCR) and Tai chi/Qigong (TCQ). However, these interventions have never been directly compared and they may help cancer patients in different ways.

MBCR focuses primarily on the challenges faced by people living with cancer. Different forms of meditation are introduced, beginning with a body scan and sensory awareness experience and progressing to sitting and walking meditations over the course of the program. Gentle Hatha yoga is incorporated throughout, as a form of moving meditation. Facilitator instruction, group discussion and reflection, problem solving, and skillful inquiry are also used.

Tai chi involves a series of slow specific movements or “forms” done in a meditative fashion to bring about a state of mental calm and clarity. Qigong exercises generally have three components: a posture (moving or stationary), breathing techniques, and mental focus on guiding chi/qi through the body. TCQ incorporates simple Tai Chi elements within a healing framework stemming from Qigong principles.

BACKGROUND

Mind-body programs like mindfulness meditation and tai chi are popular and helpful to cancer survivors, but they have rarely been compared to one-another to see which is more beneficial, and which is best for helping with specific problems. In this study we aim to directly compare participation in either Mindfulness-Based Cancer Recovery (which teaches meditation and gentle yoga) or Tai chi/Qigong groups on a range out outcomes including psychological, physical and biological measures.

WHAT IS THE PURPOSE OF THE STUDY?

The purpose of this study is to compare the two intervention groups on a range of psychological outcomes including stress, mood, quality of life, fatigue, pain and sleep. We will also measure blood pressure, heart rate, and take blood and saliva samples to measure immune function, stress hormones, gene expression and the length of telomeres in blood cells. We will also do a number of simple tests measuring balance, flexibility and strength.

WHAT WOULD I HAVE TO DO?

If you choose to participate in the research you will be asked to:

• Indicate whether you have a strong preference for taking either mindfulness or tai chi/qigoing classes. If you have a preference you will get the group that you want. If you don’t have a preference, we will assign you to one or the other randomly, like the flip of a coin
• Once you are assigned to a group, you will either start within a week or two, or wait three-four months to start – we will tell you how long you are assigned to wait.
• Before the group sessions begin, we will ask you to complete a package of questionnaires on the computer (or on paper), which will take about 30-45 minutes. We will also ask you to come to our offices so we can measure your blood pressure and heart rate for about 20 minutes, and conduct a few simple tests of your flexibility, balance and strength. Finally you will visit the lab either that day or over the next week, and have a small amount of blood drawn for later analysis.
• Before your classes start, you will also collect saliva (spit) samples in little tubes at home, four times a day over three days.
• Your classes will either begin shortly after that, or you will wait 3-4 months for the next class. If you are waiting, you will fill out the questionnaires and do the other tests one more time before your classes begin.
• Mindfulness classes will occur once weekly for 9 weeks and the Tai Chi classes will happen once a week for 11 weeks. Classes will be held at the Holy Cross Site of Cancer Control Alberta.
• After completing your classes, you will once again complete the same questionnaires either online at home, or on paper, and visit the hospital again for the 20 minute blood pressure test, balance, strength and flexibility tests, and to provide another small blood sample.
• 6 months later, you will come in one last time to complete the questionnaires, blood pressure test, balance, flexibility and strength tests and provide a small blood sample.

We understand that some people may decide not to complete all the classes or all the test sessions. In the event that you do stop attending sessions or inform the researchers that you are no longer interested in the study, we will ask you to complete a short phone interview about your reasons for dropping out of the group or study.

WHAT ARE THE RISKS?

We have not identified any significant risks related to this study. The group classes are generally safe and instructors will provide modifications if you have physical limitations. You may have some discomfort and slight bruising around the site of needle puncture in your arm from giving the blood samples, but this usually goes away within a day or two. The blood pressure cuff is somewhat uncomfortable when it expands but this is the same as a doctor’s blood pressure test you get at your checkups. If you feel the need for psychological support or counsel, counselling services through the Department of Psychosocial Resources, Tom Baker Cancer Center (403-355-3207) are available and are free to cancer patients and family.

WILL I BENEFIT IF I TAKE PART?

If you agree to participate in this study there may or may not be a direct benefit to you. If you have problems with distress or other symptoms your condition may be improved during the study but there is no guarantee that this research will help you. However, the mindfulness and tai chi groups are generally enjoyable and beneficial for most participants. The information we get from this study may help us to provide better treatments in the future for patients with distress.

DO I HAVE TO PARTICIPATE?

Participation in this research is completely voluntary. You are free to withdraw at any time. Withdrawal from the study will not jeopardize your health care or entitlement to services offered through the Department of Psychosocial Resources of the Tom Baker Cancer Centre. If you withdraw the data you provided up to that point will be kept in order to preserve the scientific merit of the study.

WILL I BE PAID FOR PARTICIPATING, OR DO I HAVE TO PAY FOR ANYTHING?

Participation in the group programs is a free service for study participants, and you will not incur any expenses from your involvement. Similarly, you will not be paid for your participation in this study.

WILL MY RECORDS BE KEPT PRIVATE?

All information provided by you will be treated with full confidentiality. Initially participants will be assigned an ID number and this will be used on all forms to protect your identity. The information and data gathered from you during the study will be used to answer the research question of this study and will only be accessible to the research team. In some cases the researchers will verify medical records using data collected and stored within Alberta Health Services electronic medical records, always in accordance with the Alberta Information Act. Data collected will be stored in a password-protected computer and is only available to the researchers. Hard copy data (paper etc.) will only be kept in the researcher’s office and locked in a specific drawer/filing cabinet at the Holy Cross Centre. All data will be stored according to ethics board regulations following the completion of the study.

We may also want to look into your medical records to obtain or verify information about your cancer illness and treatment. Your signature on this form also gives us this permission.
All research data gathered for the study may be used within presentations, publications, and other research purposes. Whenever your data is used, no personal information will be included and your identity will always be kept confidential.

IF I SUFFER A RESEARCH-RELATED INJURY, WILL I BE COMPENSATED?

In the event that you suffer injury as a result of participating in this research, no compensation will be provided to you by The Tom Baker Cancer Center, the University of Calgary, Alberta Health Services or the Researchers. You still have all your legal rights. Nothing said in this consent form alters your right to seek damages.