Acupressure for Fatigue in Ovarian Cancer Survivors
Study Details
Study Description
Brief Summary
The purpose of this study is to see if accupressure can help reduce the severity of fatigue experienced by ovarian cancer patients. Acupressure involves applying mild to moderate physical pressure by fingers, hand or a device to specific points on the skin to try to bring about a change in the body's functioning, in this case relief from chronic fatigue.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Acupressure plus standard of care Using AcuWand, participants will apply acupressure to points that are known to affect physiology. Participants will also receive standard of care. |
Other: Acupressure
Six weeks of daily self-administered relaxing acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure on the appropriate points on their bodies. These are points that are recognized as effective in Traditional Chinese Medicine (TCM).
Other: Standard of Care
Fatigue management provided by participants' health care providers.
|
Sham Comparator: Sham acupressure plus standard of care Using AcuWand, participants will apply acupressure to points that are not known to affect physiology. Participants will also receive standard of care. |
Other: Sham acupressure
Six weeks of daily self-administered sham acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure; however, the points that participants are instructed to use are not known to have any effect on the body.
Other: Standard of Care
Fatigue management provided by participants' health care providers.
|
Other: Standard of care Participants will receive standard of care only. |
Other: Standard of Care
Fatigue management provided by participants' health care providers.
|
Outcome Measures
Primary Outcome Measures
- Change in level of fatigue at week 6 [Baseline to week 6]
Self-reported on the Brief Fatigue Inventory (BFI)
- Change in level of fatigue up to week 24 [Baseline up to week 24]
Self-reported on the Brief Fatigue Inventory (BFI)
Secondary Outcome Measures
- Change in quality of life at week 6 [Baseline to week 6]
Self-reported on the Functional Assessment of Cancer Therapy Ovarian (FACT-O)
- Change in quality of life up to week 24 [Baseline up to week 24]
Self-reported on the Functional Assessment of Cancer Therapy Ovarian (FACT-O)
- Change in sleep quality at week 6 [Baseline to week 6]
Self-reported on the Pittsburgh Sleep Quality Index (PSQI)
- Change in sleep quality up to week 24 [Baseline up to week 24]
Self-reported on the Pittsburgh Sleep Quality Index (PSQI)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women aged 21 and older
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Diagnosis of ovarian cancer, stages I to IV
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Have average persistent fatigue defined a >=4 on the Brief Fatigue Inventory at least 50% of their days for at least 3 months
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Fatigue must have started at or after the diagnosis of ovarian cancer
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Completed all primary cancer treatments (surgery, chemotherapy at least 6 months prior), except maintenance therapies
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No other planned interventions for fatigue other than current stable medication
Exclusion Criteria:
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Medically unstable
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Acupuncture or acupressure receipt in past year
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Have a diagnosis of untreated mood disorder, e.g., bipolar or major depressive disorder
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Have a current diagnosis of anemia
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Have a current untreated diagnosis of hypothyroidism
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Have an initiation, a cessation or change of treatment of any chronic medications, dietary supplements, behavioral therapy, physical therapy, etc., or any planned change of medications, supplements or therapies during the study
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Have the possibility of becoming pregnant
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan Rogel Cancer Center
Investigators
- Principal Investigator: Suzanna M Zick, ND, MPH, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UMCC 2018.130
- HUM00143509