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
- Conditions
- Lymphedema
- Interventions
- Other: quality of life assessmentOther: educational interventionProcedure: Physical therapy
- Registration Number
- NCT00376597
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 568
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I (lymphedema education) quality of life assessment 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 (lymphedema education, physical therapy) educational intervention Description 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. Arm II (lymphedema education, physical therapy) Physical therapy Description 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. Arm I (lymphedema education) educational intervention 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 (lymphedema education, physical therapy) quality of life assessment Description 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.
- Primary Outcome Measures
Name Time Method Number of Participants Who Were Lymphedema-free 18 Months After Randomization 18 months To test, in a group randomized controlled trial, the efficacy of this program versus education only in reducing the incidence of lymphedema. Reported here is the proportion of patients who are lymphedema-free 18 months after randomization between the two arms
- Secondary Outcome Measures
Name Time Method Health-related Quality of Life as Assessed by FACT-B +4 Score 18 months To compare the health-related quality of life (FACT-B+4 score) between the two interventions. The change between baseline and month 18 for the total plus 4 score will be reported here. The total plus 4 score is an average of the physical, social, emotional, functional, FACT-G, and additional concerns sub-scales. Each sub-scale has questions ranging from 1-5. Once the average of all subscales is taken, the total plus 4 score is converted into a score out of 100. 100 being the best, 0 being the worst.
Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm 18 months To assess the agreement between patients' self-report of swelling (mild, moderation and severe) and the extent of circumferential measurement difference between treated side and the contralateral arm at the site of greatest difference. Per protocol, this analysis will include all patients and not be comparing the intervention arm with the control arm.
Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference 18 months 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.
Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength from baseline up to 18 months To characterize adherence to lymphedema prevention exercises, lymphedema knowledge and range of motion. The frequency of elastic sleeve use for heavy arm use/exercise/air travel will be reported here. Arm I did not receive a sleeve to wear, thus will not be reported.
Trial Locations
- Locations (74)
Highland General Hospital
🇺🇸Oakland, California, United States
Valley Medical Oncology
🇺🇸Fremont, California, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
John Muir/Mt. Diablo Comprehensive Cancer Center
🇺🇸Walnut Creek, California, United States
Larry G Strieff MD Medical Corporation
🇺🇸Oakland, California, United States
Lawrence Memorial Hospital
🇺🇸Lawrence, Kansas, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
🇺🇸Jupiter, Florida, United States
East Bay Radiation Oncology Center
🇺🇸Castro Valley, California, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, Indiana, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Tunnell Cancer Center at Beebe Medical Center
🇺🇸Lewes, Delaware, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Saint Joseph Regional Medical Center
🇺🇸Mishawaka, Indiana, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Cancer Care Center at John Muir Health - Concord Campus
🇺🇸Concord, California, United States
Contra Costa Regional Medical Center
🇺🇸Martinez, California, United States
El Camino Hospital Cancer Center
🇺🇸Mountain View, California, United States
North Broward Medical Center
🇺🇸Deerfield Beach, Florida, United States
Resurrection Medical Center
🇺🇸Chicago, Illinois, 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
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
Cancer Center of Kansas-Independence
🇺🇸Independence, Kansas, United States
Leo W. Jenkins Cancer Center at ECU Medical School
🇺🇸Greenville, North Carolina, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Tom K Lee, Incorporated
🇺🇸Oakland, California, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
Alexian Brothers Radiation Oncology
🇺🇸Elk Grove Village, Illinois, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, 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 - Salina
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Associates in Womens Health, PA - North Review
🇺🇸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
Cape Cod Hospital
🇺🇸Hyannis, Massachusetts, 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
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, 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 Tysons Corner Medical Center
🇺🇸McLean, Virginia, United States
Kaiser Permanente Medical Center - Fair Oaks
🇺🇸Fairfax, Virginia, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Kaiser Permanente - Gaithersburg Medical Center
🇺🇸Gaithersburg, Maryland, United States
Trinitas Comprehensive Cancer Center at Trinitas Hospital
🇺🇸Elizabeth, New Jersey, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Cookeville Regional Medical Center
🇺🇸Cookeville, Tennessee, United States
Kaiser Permanente at Capitol Hill Medical Center
🇺🇸Washington, District of Columbia, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
St. Vincent's Medical Center
🇺🇸Bridgeport, Connecticut, United States
Sacred Heart Cancer Center at Sacred Heart Hospital
🇺🇸Pensacola, Florida, United States
Union Hospital of Cecil County
🇺🇸Elkton, Maryland, United States
Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility
🇺🇸Largo, Maryland, United States
Tallahassee Memorial Hospital
🇺🇸Tallahassee, Florida, United States
Kaiser Permanente at Woodlawn Medical Center
🇺🇸Baltimore, Maryland, United States
Holy Cross Hospital
🇺🇸Silver Spring, Maryland, United States
Valley Medical Oncology Consultants - Castro Valley
🇺🇸Castro Valley, California, United States
Alta Bates Summit Medical Center - Summit Campus
🇺🇸Oakland, California, United States
Bay Area Breast Surgeons, Incorporated
🇺🇸Oakland, California, United States
Doctors Medical Center - San Pablo Campus
🇺🇸San Pablo, California, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
🇺🇸Moline, Illinois, United States
Tufts Medical Center Cancer Center
🇺🇸Boston, Massachusetts, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas - Fort Scott
🇺🇸Fort Scott, Kansas, United States
Cancer Center of Kansas, PA - Liberal
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States