PURPOSE/OBJECTIVES: To evaluate the safety and efficacy of reflexology, a complementary therapy that applies pressure to specific areas of the feet. DESIGN: Longitudinal, randomized clinical trial. SETTING: Thirteen community-based medical oncology clinics across the mid western United States. SAMPLE: A convenience sample of 385 predominantly caucasian women with advanced-stage breast cancer receiving chemotherapy and/or hormonal therapy. METHODS: Following the baseline interview, women were randomized into three primary groups: reflexology (n = 95), lay foot manipulation (LFM) (n = 95), or conventional care (n = 96). Two preliminary reflexology (n = 51) and LFM (n = 48) test groups were used to establish the protocols. Participants were interviewed again post intervention at study weeks 5 and 11. MAIN RESEARCH VARIABLES: Breast cancer-specific health-related quality of life (HRQOL), physical functioning, and symptoms. FINDINGS: No adverse events were reported. A longitudinal comparison revealed significant improvements in physical functioning for the reflexology group compared to the control group (p = 0.04). Severity of dyspnea was reduced in the reflexology group compared to the control group (p < 0.01) and the LFM group (p = 0.02). No differences were found on breast cancer-specific HRQOL, depressive symptomatology, state anxiety, pain, and nausea. CONCLUSIONS: Reflexology may be added to existing evidence-based supportive care to improve HRQOL for patients with advanced-stage breast cancer during chemotherapy and/or hormonal therapy. IMPLICATIONS FOR NURSING: Reflexology can be recommended for safety and usefulness in relieving dyspnea and enhancing functional status among women with advanced-stage breast cancer.

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