Acupressure for Fatigue in Ovarian Cancer Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-07

Study Completion Date

2024-06-18

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.

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Detailed Description

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Conditions

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Fatigue Ovarian Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Participants in the "standard of care" arm will not be blinded; however, the two self-acupressure arms will be blinded as to which acupressure treatment they have been randomized. All study staff and researchers will remain blinded until after the completion of data analyses.

Study Groups

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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.

Group Type EXPERIMENTAL

Acupressure

Intervention Type OTHER

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).

Standard of Care

Intervention Type OTHER

Fatigue management provided by participants' health care providers.

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.

Group Type SHAM_COMPARATOR

Sham acupressure

Intervention Type OTHER

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.

Standard of Care

Intervention Type OTHER

Fatigue management provided by participants' health care providers.

Standard of care

Participants will receive standard of care only.

Group Type OTHER

Standard of Care

Intervention Type OTHER

Fatigue management provided by participants' health care providers.

Interventions

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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).

Intervention Type 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.

Intervention Type OTHER

Standard of Care

Fatigue management provided by participants' health care providers.

Intervention Type OTHER

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

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No