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    Research Grants Awarded

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

    Study Section:
    Population Specific

    Scientific Abstract:
    Background: Each year, about 200,000 women are diagnosed with breast cancer in the United States . Lymphedema is a common complication of breast cancer therapy, and p atients with arm edema secondary to breast cancer therapy can experience a substantial degree of functional impairment, psychological morbidity, and diminished quality of life. Many questions exist in researching lymphedema. In addition, few providers are educated about what lymphedema is and ways to prevent and treat it. This study focuses on preventing lymphedema in women who have received full axillary node dissection and are at-risk for developing lymphedema. Objective: The overall goal of this study is to test in a randomized controlled trial design a program designed to reduce the incidence and severity of lymphedema among breast cancer survivors within CALGB, a large National Cancer Institute (NCI)-funded cancer cooperative group. Specific Aims: Aims are to (1) implement a program to prevent lymphedema among newly diagnosed breast cancer survivors in the cooperative group setting; (2) test the efficacy of this program in a randomized controlled trial versus education-only to prevent or reduce the severity of lymphedema; and (3) assess differences in health-related quality of life (HRQL) among women in each treatment arm. Study Design: A pproximately 28 CALGB institutions will recruit a total of 560 women newly diagnosed with breast cancer (stage I-III) who receive full axillary node dissection. Institutions will be randomized to one of two conditions: 1) a comprehensive program of tailored exercise, lymphedema prevention patient education, and counseling; or 2) patient education. Women will be followed for a total of 18 months and evaluations will occur at 3, 6, 12 and 18 months after enrollment. A trained CALGB nurse at each institution will assess participants’ range of motion, grip strength, arm strength, and arm circumference. Participants will also complete self-administered questionnaires to assess lymphedema knowledge, health-related quality of life, pain and swelling, range of motion, fear of breast cancer recurrence, body image, and self-efficacy. Cancer Relevance: Information gained from this study will provide important insights into the development of educational material and lymphedema prevention strategies.

    Lay Abstract:
    Each year, about 200,000 women are diagnosed with breast cancer in the United States . Patients with arm lymphedema as a result of breast cancer treatment accumulate fluid in their arms, which can result in a substantial degree of functional impairment, psychological morbidity, and diminished quality of life. Many questions exist in researching lymphedema. In addition, few health care providers are educated about what lymphedema is and ways to prevent and treat it. This confusion leads to general neglect of this disfiguring and sometimes debilitating condition that affects 400,000 to over one million breast cancer survivors on a daily basis. This study focuses on preventing lymphedema in women who have received full axillary node dissection and are at-risk for developing lymphedema. The overall goal of this study is to test a program designed to reduce the incidence and severity of lymphedema among breast cancer survivors within CALGB, a large National Cancer Institute (NCI)-funded cancer cooperative group. Specifically, in this study, we will: 1) Deliver a program to prevent lymphedema among newly diagnosed breast cancer survivors in the cooperative group setting; 2) Test the effectiveness of this program in a randomized controlled trial versus education-only to prevent or reduce the severity of lymphedema; and 3) Assess differences in health-related quality of life (HRQL) among women in each treatment arm. The potential impact of this study is significant for cancer survivors, and the results can be used in a variety of settings to educate providers and at-risk patients about this condition. In addition, refinement of measurements for lymphedema will allow clinicians to implement consistent methods to identify affected patients at early stages and initiate appropriate treatment as soon as possible when chances for reduction of swelling are greatest.