Trial Information

Reflexology: An Intervention for Advanced Breast Cancer

The goal of this study is to test a complementary therapy intervention that will assist in
improving quality of life (QOL) for women undergoing chemotherapy for late stage (III and
IV) breast cancer within the context of conventional medical care. This longitudinal
randomized clinical trial (RCT) will test a three-group design in which participants will
continue to receive conventional care. Two groups of the study will involve a single-blinded
four-week protocol: Group A will receive reflexology (a specialized foot therapy) from a
certified reflexologist; Group B will receive placebo sessions from a research aide. The
control group (Group C) will receive conventional medical care alone. The specific aims are:
1) to determine if women who receive either Groups (A or B) of an experimental protocol
(reflexology or placebo) report significantly better QOL outcomes (total and subscales) at 7
weeks, 13 weeks, and longitudinally over time, relative to women receiving conventional care
alone (Group C); 2) to determine if women who receive Group A of an experimental protocol
(reflexology), report significantly better QOL outcomes (total and subscales) at 7 weeks, 13
weeks, and longitudinally over time, relative to women receiving Group B (placebo; 3) to
determine if women who receive either Group A or B of an experimental protocol (reflexology
or placebo), report significant differences on Intermediate Indicators (physical and
emotional), at 7 weeks, 13 weeks, and longitudinally over time, relative to women receiving
conventional care alone; and 4) to determine if the Intermediate Indicators mediate the
group effect on the QOL outcomes (total and subscales) at 7 weeks. This has the potential of
leading to an enhanced system of care through the integration of conventional and
scientifically-based complementary therapies. It also focuses on advanced disease that is
currently under investigation in terms of supportive care measures. Finally, this study
utilizes an improved design over existing work. It is a RCT with adequate numbers to detect
group differences, and could ultimately serve as a model for rigorous investigation of other
complementary therapies.