Acupressure for Fatigue in Ovarian Cancer Survivors

Not Applicable

Completed

• Conditions: Fatigue; Ovarian Cancer
• Interventions: Other: Sham acupressure; Other: Acupressure; Other: Standard of Care

• Registration Number: NCT03763838
• Lead Sponsor: University of Michigan Rogel Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-04
• Study Start: 2019-10-07
• Primary Completion: 2024-06-18
• Study Completion: 2024-06-18
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham acupressure plus standard of care	Sham acupressure	Using AcuWand, participants will apply acupressure to points that are not known to affect physiology. Participants will also receive standard of care.
Acupressure plus standard of care	Acupressure	Using AcuWand, participants will apply acupressure to points that are known to affect physiology. Participants will also receive standard of care.
Sham acupressure plus standard of care	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.
Standard of care	Standard of Care	Participants will receive standard of care only.
Acupressure plus standard of care	Standard of Care	Using AcuWand, participants will apply acupressure to points that are known to affect physiology. Participants will also receive standard of care.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

University of Michigan Rogel Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States