Using SMART Design to Improve Symptom Management Strategies Among Cancer Patients
NCT ID: NCT02759146
Last Updated: 2020-12-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
347 participants
INTERVENTIONAL
2016-05-31
2019-11-30
Brief Summary
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Detailed Description
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The re-randomization placed the non-responders in either a group that received a higher dose (more time) with the first intervention or to the alternate practice (meditative practice to those randomized to reflexology and vice versa) for weeks 5-8. Those who did respond during weeks 1-4 continued the same therapy they began with.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Reflexology
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
Reflexology
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
Meditative Practice
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns
Meditative Practices
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns
Control
Control - no intervention
No interventions assigned to this group
Interventions
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Reflexology
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
Meditative Practices
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns
Eligibility Criteria
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Inclusion Criteria
* Solid tumor cancer diagnosis
* Able to perform basic activities of daily living (ADLs)
* Undergoing chemotherapy, hormonal therapy, or targeted therapy
* Able to speak and understand English
* Have access to a telephone
* Able to hear normal conversation
* Reporting a severity of 3 or higher on fatigue using a 0-10 standardized scale at intake.
Exclusion Criteria
* Residing in a nursing home
* Bedridden
* Currently receiving reflexology or meditative practices
* Suspected or diagnosed deep vein thrombosis or painful foot neuropathy.
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Michigan State University
OTHER
Responsible Party
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Gwen Wyatt
Professor
Principal Investigators
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Gwen Wyatt, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
Michigan State University College of Nursing
Locations
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Arizona Oncology
Tucson, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Northwestern University
Chicago, Illinois, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
MSU Breslin Cancer Center
Lansing, Michigan, United States
Sparrow Cancer Center
Lansing, Michigan, United States
Countries
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References
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Thana K, Sikorskii A, Lehto R, Guhaniyogi P, Brewer S, Victorson D, Pace T, Badger T, Wyatt G. Family caregivers of those with cancer: quality of life outcomes from a sequential multiple assignment randomized trial. Support Care Cancer. 2022 Jul;30(7):5891-5902. doi: 10.1007/s00520-022-07012-7. Epub 2022 Apr 5.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PA13-165
Identifier Type: -
Identifier Source: org_study_id