Breast Cancer Clinical Trial
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
Summary
This randomized phase III trial studies how well education with or without physical therapy intervention works in preventing lymphedema in women with stage I, II, or III breast cancer who are undergoing axillary lymph node dissection (surgery to remove lymph nodes found in the armpit region). Lymphedema is a condition in which extra lymph fluid builds up in tissues and causes swelling in an arm or leg if lymph vessels are blocked, damaged, or removed by surgery. A personalized physical therapy intervention and education materials may be better than education materials alone in preventing lymphedema in women with breast cancer who are undergoing axillary lymph node dissection.
Full Description
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
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
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There are 65 Locations for this study
Castro Valley California, 94546, United States
Castro Valley California, 94546, United States
Concord California, 94524, United States
Fremont California, 94538, United States
Martinez California, 94553, United States
Mountain View California, 94040, United States
Oakland California, 94602, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
San Pablo California, 94806, United States
Walnut Creek California, 94598, United States
Bridgeport Connecticut, 06606, United States
Lewes Delaware, 19958, United States
Newark Delaware, 19713, United States
Washington District of Columbia, 20002, United States
Washington District of Columbia, 20007, United States
Deerfield Beach Florida, 33064, United States
Jupiter Florida, 33458, United States
Miami Beach Florida, 33140, United States
Pensacola Florida, 32504, United States
Tallahassee Florida, 32308, United States
Chicago Illinois, 60631, United States
Chicago Illinois, 60637, United States
Elk Grove Village Illinois, 60007, United States
Harvey Illinois, 60426, United States
Moline Illinois, 61265, United States
Moline Illinois, 61265, United States
La Porte Indiana, 46350, United States
Mishawaka Indiana, 46545, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46601, United States
Bettendorf Iowa, 52722, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Fort Scott Kansas, 66701, United States
Independence Kansas, 67301, United States
Kingman Kansas, 67068, United States
Lawrence Kansas, 66044, United States
Liberal Kansas, 67901, United States
McPherson Kansas, 67460, United States
Newton Kansas, 67114, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67401, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Lexington Kentucky, 40503, United States
York Maine, 03909, United States
Baltimore Maryland, 21244, United States
Elkton Maryland, 21921, United States
Gaithersburg Maryland, 20879, United States
Largo Maryland, 20774, United States
Silver Spring Maryland, 20910, United States
Boston Massachusetts, 02111, United States
Hyannis Massachusetts, 02601, United States
Elizabeth New Jersey, 07207, United States
Voorhees New Jersey, 08043, United States
Staten Island New York, 10305, United States
Greenville North Carolina, 27834, United States
Fargo North Dakota, 58122, United States
Columbus Ohio, 43210, United States
Cookeville Tennessee, 38501, United States
Houston Texas, 77030, United States
Laredo Texas, 78045, United States
Fairfax Virginia, 22033, United States
McLean Virginia, 22102, United States
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