Acupressure for Fatigue in Ovarian Cancer Survivors

Study Overview
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Brief Summary
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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.

Official Title
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Acupressure for Fatigue in Ovarian Cancer Survivors

Conditions
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Fatigue, Ovarian Cancer

Intervention / Treatment
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* Other: Acupressure
* Other: Sham acupressure
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 21 and older Diagnosis of ovarian cancer, stages I to IV Have average persistent fatigue defined a >=4 on the Brief Fatigue Inventory. Fatigue must have started at or after the diagnosis of ovarian cancer Completed all primary cancer treatments (surgery, chemotherapy at least 6 months prior), except maintenance therapies No other planned interventions for fatigue other than current stable medication Exclusion Criteria: Medically unstable Acupuncture or acupressure receipt in past year Have a diagnosis of untreated mood disorder, e.g., bipolar or major depressive disorder Have a current diagnosis of anemia Have a current untreated diagnosis of hypothyroidism 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 Have the possibility of becoming pregnant

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupressure plus standard of care<br>Using AcuWand, participants will apply acupressure to points that are known to affect physiology. Participants will also receive standard of care. | Other: Acupressure<br>* 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).<br>Other: Standard of Care<br>* Fatigue management provided by participants' health care providers.<br>|
| Sham Comparator: Sham acupressure plus standard of care<br>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<br>* 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.<br>Other: Standard of Care<br>* Fatigue management provided by participants' health care providers.<br>|
| Other: Standard of care<br>Participants will receive standard of care only. | Other: Standard of Care<br>* Fatigue management provided by participants' health care providers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in level of fatigue at week 6 | Self-reported on the Brief Fatigue Inventory (BFI) | Baseline to week 6 | 
| Change in level of fatigue up to week 24 | Self-reported on the Brief Fatigue Inventory (BFI) | Baseline up to week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life at week 6 | Self-reported on the Functional Assessment of Cancer Therapy Ovarian (FACT-O) | Baseline to week 6 | 
| Change in quality of life up to week 24 | Self-reported on the Functional Assessment of Cancer Therapy Ovarian (FACT-O) | Baseline up to week 24 | 
| Change in sleep quality at week 6 | Self-reported on the Pittsburgh Sleep Quality Index (PSQI) | Baseline to week 6 | 
| Change in sleep quality up to week 24 | Self-reported on the Pittsburgh Sleep Quality Index (PSQI) | Baseline up to week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupressure