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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA104883-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The aim 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 or IV) breast cancer within the context of conventional medical care. Quality of life will be assessed via intermediate indicators: 1) physical indicators (greater physical functioning, lower presence of symptoms) 2) emotional indicators (greater spirituality, lower anxiety, and lower depressive symptomology); and the outcome indicator of quality of life.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Reflexology Sessions: One session per week performed by certified reflexologist for four consecutive weeks. |
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| Group B | Placebo Comparator | Placebo Sessions: One session per week performed by research aide for four consecutive weeks. |
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| Group C | No Intervention | Control; no foot sessions |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reflexology Sessions | Other | One session per week performed by certified reflexologist for four consecutive weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of Life | Baseline to week 13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gwen Wyatt, PhD, RN | Michigan State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evanston Northwestern | Evanston | Illinois | 60201 | United States | ||
| Mt. Clemens |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19918155 | Background | Sikorskii A, Wyatt G, Victorson D, Faulkner G, Rahbar MH. Methodological issues in trials of complementary and alternative medicine interventions. Nurs Res. 2009 Nov-Dec;58(6):444-51. doi: 10.1097/NNR.0b013e3181bf15fe. | |
| 21664296 | Background | Rahbar MH, Wyatt G, Sikorskii A, Victorson D, Ardjomand-Hessabi M. Coordination and management of multisite complementary and alternative medicine (CAM) therapies: experience from a multisite reflexology intervention trial. Contemp Clin Trials. 2011 Sep;32(5):620-9. doi: 10.1016/j.cct.2011.05.015. Epub 2011 Jun 2. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Placebo Sessions | Other | One session per week performed by research aide for four consecutive weeks. |
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| Evanston |
| Illinois |
| 60201 |
| United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| GLCI/McLaren | Flint | Michigan | 48532 | United States |
| St. Joseph Mercy Oakland Hospital | Grand Rapids | Michigan | 44405 | United States |
| St. Mary's Health Care Center | Grand Rapids | Michigan | 49503 | United States |
| Great Lakes Cancer Institute (GLCI) MSU | Lansing | Michigan | 48910 | United States |
| Sparrow Hospital | Lansing | Michigan | 48912 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| William Beaumont Hospital-Troy Campus | Troy | Michigan | 48085 | United States |
| St. John Macomb | Warren | Michigan | 48093 | United States |
| Josephine Ford Cancer Care, Henry Ford Hospital | West Bloomfield | Michigan | 48323 | United States |
| 20467309 | Background | Wyatt G, Sikorskii A, Rahbar MH, Victorson D, Adams L. Intervention fidelity: aspects of complementary and alternative medicine research. Cancer Nurs. 2010 Sep-Oct;33(5):331-42. doi: 10.1097/NCC.0b013e3181d0b4b7. |
| 19620179 | Result | Sikorskii A, Wyatt GK, Siddiqi AE, Tamkus D. Recruitment and early retention of women with advanced breast cancer in a complementary and alternative medicine trial. Evid Based Complement Alternat Med. 2011;2011:734517. doi: 10.1093/ecam/nep051. Epub 2011 Feb 14. |
| D017437 |
| Skin and Connective Tissue Diseases |