Trial Information

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

OBJECTIVES:

Primary

- 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.

Secondary

- 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.