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

Phase 3

Completed

Conditions: Lymphedema

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

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): 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
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East Bay Radiation Oncology Center
🇺🇸Castro Valley, California, United States