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 subscale) 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 research is relevant because it addresses the high use of complementary therapies by cancer patients, and 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 which is currently under investigated 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.
| Wyatt, Gwen; Sikorskii, Alla; Tesnjak, Irena et al. (2015) Chemotherapy interruptions in relation to symptom severity in advanced breast cancer. Support Care Cancer 23:3183-91 |
| Zecker, Steven G; Hoffman, Howard J; Frisina, Robert et al. (2013) Audition assessment using the NIH Toolbox. Neurology 80:S45-8 |
| Nowinski, Cindy J; Victorson, David; Debb, Scott M et al. (2013) Input on NIH Toolbox inclusion criteria: surveying the end-user community. Neurology 80:S7-12 |
| Cook, Karon F; Dunn, Winnie; Griffith, James W et al. (2013) Pain assessment using the NIH Toolbox. Neurology 80:S49-53 |
| Coldwell, Susan E; Mennella, Julie A; Duffy, Valerie B et al. (2013) Gustation assessment using the NIH Toolbox. Neurology 80:S20-4 |
| Wyatt, G; Sikorskii, A; Tamkus, D et al. (2013) Quality of life among advanced breast cancer patients with and without distant metastasis. Eur J Cancer Care (Engl) 22:272-80 |
| Wyatt, Gwen; Sikorskii, Alla; You, Mei (2013) Self-reported use of complementary and alternative medicine therapies in a reflexology randomized clinical trial. Altern Ther Health Med 19:31-7 |
| Victorson, David; Manly, Jennifer; Wallner-Allen, Kathleen et al. (2013) Using the NIH Toolbox in special populations: considerations for assessment of pediatric, geriatric, culturally diverse, non-English-speaking, and disabled individuals. Neurology 80:S13-9 |
| Dunn, Winnie; Griffith, James W; Morrison, M Tracy et al. (2013) Somatosensation assessment using the NIH Toolbox. Neurology 80:S41-4 |
| Sikorskii, Alla; Wyatt, Gwen; Tamkus, Deimante et al. (2012) Concordance between patient reports of cancer-related symptoms and medical records documentation. J Pain Symptom Manage 44:362-72 |
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