Title of Project: Reflexology: An Intervention for Advanced Breast Cancer
PI: Gwen Wyatt Co-Investigators: Alla Sikorskii, Hossein Rahbar Funding agency: NCI (reviewed by NINR) Dates of Project: 6/1/05 to 5/31/10 Budget: $ 3,127,692 Abstract/Description of Project: Reflexology: An Intervention for Advanced Breast Cancer Gwen Wyatt (PI) 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. Gwen Wyatt, RN, PhD Professor, College of Nursing 422 West Fee Hall Michigan State University E. Lansing, MI 48824 gwyatt@msu.edu 517-432-5511
Executive Summary The following is an executive summary for the project titled, “Reflexology: An Intervention for Advanced Breast Cancer.” Gwen Wyatt, RN, PhD is the principal investigator. This research project is a collaborative effort involving the College of Nursing at Michigan State University and West Michigan Cancer Center. It is funded by the National Institutes of Cancer 1 RO1 CA104883-01A1. Background Over the past 15 years, several national studies, both U.S. and Canadian, have been conducted on the use of complementary therapies by the general public for relief of a wide variety of symptoms. These surveys pointed out the fact that not only do large numbers of cancer patients use complementary therapies, but they often do so without their doctor’s knowledge or approval. Do to this fact, we conducted a pilot study at West Michigan Cancer Center to determine which therapies were the most desirable and to evaluate beneficial outcomes. We found that women with breast cancer expressed the largest interest, and that the therapy most often maintained over the course of the study was reflexology (a specialized foot therapy). Therefore, we now plan to explore the effectiveness of reflexology more rigorously within the formal oncology care setting. We will evaluate the quality of life of breast cancer patients, and examine the influence of reflexology on their physical and psychological well being. Complementary Therapy intervention The goal of this study is to test a complementary therapy intervention (reflexology) 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. Conclusions This project 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. In this era of competition in health care, many treatment facilities are adding “amenities menus” to their standard of care. This is a menu of support services offered in addition to conventional chemotherapy and radiation. These supportive measures are intended to create a less stressful link for the patient to the treatment center. Instead of dreading the next cancer treatment, patients are able to focus on the comfort measure that will be provided during treatment. Through this project, we would like to help initiate such a concept that could be transferable to any cancer therapy clinic in order to improve the cancer treatment experience for all patients. Gwen Wyatt, RN, PhD Professor, College of Nursing 422 West Fee Hall Michigan State University E. Lansing, MI 48824 gwyatt@msu.edu 517-432-5511
Διαβάστε την ιστορία του πως δόθηκε από το National Institute of Health η επιχορήγηση των $3.1 εκατομμυρίων δολλαρίων για να γίνει η έρευνα κλικάροντας εδώ.
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