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
Recruitment status was Recruiting
RATIONALE: A personalized exercise program, counseling, and education materials may be more effective than education materials alone in preventing lymphedema in women with breast cancer who are undergoing axillary lymph node dissection.
PURPOSE: This randomized clinical trial is studying how well education with or without exercise and counseling works in preventing lymphedema in women with stage I, stage II, or stage III breast cancer who are undergoing axillary lymph node dissection.
Behavioral: exercise intervention
Other: educational intervention
Procedure: assessment of therapy complications
Procedure: complementary or alternative medicine procedure
Procedure: management of therapy complications
Procedure: quality-of-life assessment
Procedure: therapeutic conventional surgery
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer|
- Lymphedema incidence (percentage of women who remain free from the presence of lymphedema for 18 months) [ Designated as safety issue: No ]
- Severity of lymphedema as assessed by changes in arm circumference [ Designated as safety issue: No ]
- Agreement between patients' self-report of swelling and the extent of circumferential measurement difference between the treated side and the contralateral arm [ Designated as safety issue: No ]
- Health-related quality of life as assessed by Functional Assessment of Cancer Therapy-Breast (FACT-B) +4 score [ Designated as safety issue: No ]
- Adherence to lymphedema prevention exercises, lymphedema knowledge, range of motion, and arm strength [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
- Determine the efficacy of a comprehensive program of tailored exercise, lymphedema prevention patient education, and counseling vs lymphedema prevention patient education only in reducing the incidence of lymphedema in women with stage I-III breast cancer who are undergoing axillary lymph node dissection.
- Compare the severity of lymphedema, in terms of changes in arm circumference at the site of greatest difference as a continuous variable, in patients undergoing these interventions.
- Assess the agreement between patients' self-report of swelling (mild, moderate, or severe) and the extent of circumferential measurement difference between the treated side and the contralateral arm at the site of greatest difference (< 0.5 inches vs ≥ 0.5 and < 2 inches vs ≥ 2 inches).
- Compare the health-related quality of life of these patients.
- Characterize adherence to lymphedema prevention exercises, lymphedema knowledge, and range of motion.
OUTLINE: This is a randomized, controlled, multicenter study where the unit of randomization is the participating center. Participating centers are stratified according to the annual number of patients with stage I-III breast cancer who undergo axillary node dissection at the center (small vs moderate vs large number of patients) and are randomized to 1 of 2 arms. Patients are thus randomized to 1 of 2 intervention arms based on the identified participating center.
All patients complete questionnaires prior to surgery regarding lymphedema knowledge, health-related quality of life, fear of cancer recurrence, self-efficacy, body-image, self-report of range of motion, arm circumference, and demographics. Patients then undergo surgery, which must include axillary node dissection.
- 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 exercise regimen, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.
PROJECTED ACCRUAL: A total of 560 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00376597
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|Study Chair:||Electra D. Paskett, PhD||Ohio State University Comprehensive Cancer Center|