UCSF Symptom Management Research

The purposes of this study are to better understand the signs and symptoms of breast cancer lymphedema and the genetic factors that predict whether patients develop lymphedema or not. The results of this study will provide new information on the underlying mechanisms for lymphedema and allow for the development and testing of new approaches to prevent or reduce the negative effects of lymphedema.

Christine Miaskowski, RN, PhD, from the department of Physiological Nursing, University of California, San Francisco, is the Principal Investigator and her colleagues from the departments of Medicine and Physical Therapy & Rehabilitation Sciences at UCSF and the Carol Franc Buck Breast Cancer Center are conducting this study.

A total of 900 women will be enrolled in this study, 650 with lymphedema and 250 without lymphedema. We have reached our recruitment goal for women without lymphedema, and currently are only enrolling women with lymphedema.

Completing an Online Survey: The survey will ask for information about your date of birth, gender, race, ethnicity, education, marital status, living arrangement, and employment; your ability to care for yourself, your health history, the symptoms you may be experiencing in your arms and hands, and medications, nutritional supplements or herbs you are currently taking; depression, pain, fatigue, sleep disturbance, and your quality of life. If the internet is not available or the participant prefers a hard copy, they will be accommodated.

UCSF Visit: During the visit, measurements will be taken, as well as a blood specimen.

Your height, weight, movement and strength in your shoulders, and strength of your hand grip will be measured.

•  The size of your arms will be measured by using a tape to measure five locations on each arm.
• The fluid content of your body and each arm may be measured by using a bioelectrical impedance machine. You will be asked to stand on a scale-like device and hold onto handles. A very small amount of electricity will pass through your body. This test is completely painless and has no side effects.
• The sensation (feeling) in your arms and hands will be tested as follows:
• You will be asked to close your eyes and the researcher will touch you lightly on different areas of the hands and arms with a slender nylon filament. Each area will be touched 3 times, with up to 5 or more different sizes of the filament, for a maximum of 15 touches at each area. You will be asked to say if you felt any or all of the touches.
• With your eyes closed, the researcher will touch your hands and arms with a device that tests your ability to feel a cold temperature. You will be asked to tell when you sense the cold temperature.

Questionnaire & Review: One of the questionnaires you completed prior to your visit asked you about symptoms of depression. The researcher will review this questionnaire during your study visit and if your answers indicate that you are having symptoms of depression, the RN will speak with you about these symptoms.

One of the questionnaires you completed prior to your visit asked you about major stressful life events. The researcher will review this questionnaire prior to your study visit. If you reveal on the questionnaire that you are currently being physically and/or sexually abused, the researchers are ethically obligated to report this abuse to law enforcement, which could increase the abuse if it became known we had to report it. To minimize this risk, our research staff would help you contact a social worker to plan for safe housing options for you and provide a list of other local community resources if you wish.

Blood Draw: About 2.5 tablespoons (37 mls) of your blood will be taken from a vein to study the genes (inherited factors, DNA) and other biological markers that may be related to breast cancer lymphedema. The researchers will review your current medications with you. Your medical history will also be reviewed related to your cancer treatment.

The online surveys take approximately 3 hours to complete. We recommend you take the survey in several sessions over the two weeks prior to your study visit. Your study visit will also take approximately 2 hours.

The online survey can be done at home or wherever you have connection to the internet. The study visit will take place at the University of California, San Francisco, Parnassus campus or at one of our community partner locaitons.

Yes. Research is always voluntary—you can decide to stop being in the study at any time you wish.

The researcher will measure your strength and ability to move each shoulder through 4 different positions. You may have some discomfort or pain with these movements. You can refuse to do any or all of these movements.

The bioelectrical impedance test takes less than 5 minutes to do. You should not be able to sense when the measurement is taking place. If you do sense any discomfort, immediately inform the researcher.

Having blood drawn will result in a sensation like an insect bite. Sometimes a bruise occurs at the site where the blood is taken. Rarely, an infection may occur.

Study data will by physically and electronically secured. As with any use of electronic means to store data, there is a risk of breach of data security. Your name will not be used in any published reports from research performed for this study. The research staff will not release any identifying information about you to their collaborators.

Genetic information that results from this study does not have medical or treatment importance at this time. To safeguard your privacy, genetic information obtained in this study will not be placed in your medical record.

If you do not share information about taking part in this study, you will reduce your risk to your privacy. Although your name will not be with the sample, it will have other facts about you such as age, characteristics, diagnosis, and treatment. These facts are important because they will help us learn if the factors, that cause cancer treatment side effects to occur or get worse, are the same or different based on these facts. Thus it is possible that study findings could one day help people of the same characteristics as you. However, it is possible through these kinds of studies that traits might become associated with your group.

There will be no direct benefit to you from participating in this study. However, this study will help health professionals learn more about the risk factors and treatment of breast cancer lymphedema in the future.

You are free to choose not to participate in this study. If you decide not to take part in this study, there will be no penalty to you.

We will do our best to make sure that the personal information gathered for this study is kept private. However, we cannot guarantee total privacy. You may be part of a report to the UCSF Cancer Center that includes all of their patients participating in UCSF cancer research. Your signed consent form will be added to your UCSF medical record. Therefore, people involved with your future care and insurance may become aware of your participation. Hospital regulations require that all health care providers treat information in medical records confidentially. Study information will be coded and kept in a password secured and encrypted server and in locked files at all times. Only Dr. Miaskowski and the research team will have access to these files. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.

There is no cost to you to participate in this study.

You will be paid $150 at the completion of this study in exchange for your time and transportation costs. A check will be mailed to you in about 4-6 weeks after you complete the study.