Education With or Without Exercise and Counseling in Preventing Lymphedema in Women With Stage I, Stage II, or Stage III Breast Cancer Who Are Undergoing Axillary Lymph Node Dissection

OBJECTIVES:

I. To test, in a group randomized controlled trial, the efficacy of this program versus
education only in reducing the incidence of lymphedema.

II. To compare the severity of lymphedema, in terms of changes in arm circumference at the
site of greatest difference as a continuous variable between the two interventions.

III. To assess the agreement between patients' self-report of swelling (mild, moderate, and
severe) and the extent of circumferential measurement difference between the treated side and
the contralateral arm at the site of greatest difference.

IV. To compare the health-related quality of life (Factional Assessment of Cancer
Therapy-Breast [FACT-B]+4 score) between the two interventions.

V. To characterize adherence to lymphedema prevention exercises, lymphedema knowledge, and
range of motion.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Six weeks after surgery, patients receive a brief initial post-operative care session
describing lymphedema risk and prevention through oral instruction and written materials.
Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18
months. Patients are also contacted by telephone at 9 and 15 months.

ARM II: Patients receive lymphedema education and complete physical assessments and
questionnaires as in Arm I. Patients also complete a personalized physical therapy
intervention, receive a refrigerator magnet, and a 15-minute video that reinforces
information and exercises.

Eligibility Criteria:

- Newly diagnosed with stage I-III cancer of the female breast

- No prior history of carcinoma in situ, lobular carcinoma in situ (LCIS), ductal
carcinoma in situ (DCIS), or invasive breast cancer

* Patients with a history of other invasive malignancies are eligible as long as they
have completed treatment and are 5 years post-diagnosis; patients with basal cell and
squamous cell cancer of the skin are eligible

- Neoadjuvant therapy

- Patients scheduled to receive any type of radiation therapy to the breast or
axilla are eligible; however, they must be registered to this study with
pre-surgery measures taken prior to receiving neoadjuvant therapy

- Patients scheduled to receive neoadjuvant chemotherapy are also eligible;
however, they must be registered to this study with pre-surgery measurements
taken prior to receiving neoadjuvant therapy

- Patients receiving no neoadjuvant therapy are eligible

- May be enrolled on other treatment trials; however, patients enrolled on surgery
trials where only one treatment arm is full axillary node dissection are not eligible;
NOTE: Patients enrolled on American College of Surgeons Oncology Group (ACOSOG)-Z1071
are eligible to participate in this study; patients concurrently enrolled on this
study and ACOSOG-Z1071, may not also be enrolled on the ACOSOG-Z1071 lymphedema
sub-study

- No documented cardiac conduction disturbances, unstable angina, dementia, or any other
chronic disease which, in the opinion of the treating physician, significantly
increases mortality over the next 2 years

- No diagnosed lymphedema

- In order to be properly fitted for the elastic sleeve, eligible patients must have arm
measurements for axilla, elbow, and wrist that fall within the ranges for one of the
six sleeve sizes

- Not currently homebound or dependent upon a walker or wheelchair for mobility

- Able to participate in a mild exercise program

- Willing to return to the study site for the duration of the study (18 months)

- Sentinel (SND) or full axillary node dissection (AND) (no minimum number of nodes
required)

- Patients with double mastectomy, axillary node dissection and/or radiation on both
arms are ineligible; patients who undergo these treatments (i.e., surgery and/or
radiation) on the contralateral arm after registration to Step 2 are still eligible to
remain in the study; however, it should be documented appropriately on form C-1628 at
the conclusion of study participation