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Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

Official Title: A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer

Study ID: NCT00376597

Conditions

Lymphedema

Study Description

Brief 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.

Detailed 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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

East Bay Radiation Oncology Center, Castro Valley, California, United States

Valley Medical Oncology Consultants - Castro Valley, Castro Valley, California, United States

Cancer Care Center at John Muir Health - Concord Campus, Concord, California, United States

Valley Medical Oncology, Fremont, California, United States

Contra Costa Regional Medical Center, Martinez, California, United States

El Camino Hospital Cancer Center, Mountain View, California, United States

Highland General Hospital, Oakland, California, United States

Alta Bates Summit Medical Center - Summit Campus, Oakland, California, United States

Bay Area Breast Surgeons, Incorporated, Oakland, California, United States

CCOP - Bay Area Tumor Institute, Oakland, California, United States

Larry G Strieff MD Medical Corporation, Oakland, California, United States

Tom K Lee, Incorporated, Oakland, California, United States

Doctors Medical Center - San Pablo Campus, San Pablo, California, United States

John Muir/Mt. Diablo Comprehensive Cancer Center, Walnut Creek, California, United States

St. Vincent's Medical Center, Bridgeport, Connecticut, United States

Tunnell Cancer Center at Beebe Medical Center, Lewes, Delaware, United States

CCOP - Christiana Care Health Services, Newark, Delaware, United States

Kaiser Permanente at Capitol Hill Medical Center, Washington, District of Columbia, United States

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, United States

North Broward Medical Center, Deerfield Beach, Florida, United States

Ella Milbank Foshay Cancer Center at Jupiter Medical Center, Jupiter, Florida, United States

CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States

Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola, Florida, United States

Tallahassee Memorial Hospital, Tallahassee, Florida, United States

Resurrection Medical Center, Chicago, Illinois, United States

University of Chicago Cancer Research Center, Chicago, Illinois, United States

Alexian Brothers Radiation Oncology, Elk Grove Village, Illinois, United States

Ingalls Cancer Care Center at Ingalls Memorial Hospital, Harvey, Illinois, United States

Trinity Cancer Center at Trinity Medical Center - 7th Street Campus, Moline, Illinois, United States

, Moline, Illinois, United States

Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, United States

Saint Joseph Regional Medical Center, Mishawaka, Indiana, United States

CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States

Memorial Hospital of South Bend, South Bend, Indiana, United States

Michiana Hematology-Oncology, PC - South Bend, South Bend, Indiana, United States

, Bettendorf, Iowa, United States

Cancer Center of Kansas, PA - Chanute, Chanute, Kansas, United States

Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas, United States

Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas, United States

Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States

Cancer Center of Kansas-Independence, Independence, Kansas, United States

Cancer Center of Kansas, PA - Kingman, Kingman, Kansas, United States

Lawrence Memorial Hospital, Lawrence, Kansas, United States

Cancer Center of Kansas, PA - Liberal, Liberal, Kansas, United States

Cancer Center of Kansas, PA - McPherson, McPherson, Kansas, United States

Cancer Center of Kansas, PA - Newton, Newton, Kansas, United States

Cancer Center of Kansas, PA - Parsons, Parsons, Kansas, United States

Cancer Center of Kansas, PA - Pratt, Pratt, Kansas, United States

Cancer Center of Kansas, PA - Salina, Salina, Kansas, United States

Cancer Center of Kansas, PA - Wellington, Wellington, Kansas, United States

Associates in Womens Health, PA - North Review, Wichita, Kansas, United States

Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas, United States

Cancer Center of Kansas, PA - Wichita, Wichita, Kansas, United States

CCOP - Wichita, Wichita, Kansas, United States

Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States

Cancer Center of Kansas, PA - Winfield, Winfield, Kansas, United States

Central Baptist Hospital, Lexington, Kentucky, United States

York Hospital's Oncology Treatment Center, York, Maine, United States

Kaiser Permanente at Woodlawn Medical Center, Baltimore, Maryland, United States

Union Hospital of Cecil County, Elkton, Maryland, United States

Kaiser Permanente - Gaithersburg Medical Center, Gaithersburg, Maryland, United States

Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility, Largo, Maryland, United States

Holy Cross Hospital, Silver Spring, Maryland, United States

Tufts Medical Center Cancer Center, Boston, Massachusetts, United States

Cape Cod Hospital, Hyannis, Massachusetts, United States

Trinitas Comprehensive Cancer Center at Trinitas Hospital, Elizabeth, New Jersey, United States

Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey, United States

Nalitt Cancer Institute at Staten Island University Hospital, Staten Island, New York, United States

Leo W. Jenkins Cancer Center at ECU Medical School, Greenville, North Carolina, United States

CCOP - MeritCare Hospital, Fargo, North Dakota, United States

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Cookeville Regional Medical Center, Cookeville, Tennessee, United States

M. D. Anderson Cancer Center at University of Texas, Houston, Texas, United States

Doctor's Hospital of Laredo, Laredo, Texas, United States

Kaiser Permanente Medical Center - Fair Oaks, Fairfax, Virginia, United States

Kaiser Permanente Tysons Corner Medical Center, McLean, Virginia, United States

Contact Details

Name: Electra D. Paskett, PhD

Affiliation: Ohio State University Comprehensive Cancer Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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