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Acupressure for Fatigue in Ovarian Cancer Survivors

Primary Purpose

Fatigue, Ovarian Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupressure
Sham acupressure
Standard of Care
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fatigue focused on measuring Acupressure

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 at least 50% of their days for at least 3 months
  • 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

Sites / Locations

  • University of Michigan Rogel Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Other

Arm Label

Acupressure plus standard of care

Sham acupressure plus standard of care

Standard of care

Arm Description

Using AcuWand, participants will apply acupressure to points that are known to affect physiology. Participants will also receive 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.

Participants will receive standard of care only.

Outcomes

Primary Outcome Measures

Change in level of fatigue at week 6
Self-reported on the Brief Fatigue Inventory (BFI)
Change in level of fatigue up to week 24
Self-reported on the Brief Fatigue Inventory (BFI)

Secondary Outcome Measures

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

Full Information

First Posted
December 3, 2018
Last Updated
April 5, 2023
Sponsor
University of Michigan Rogel Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03763838
Brief Title
Acupressure for Fatigue in Ovarian Cancer Survivors
Official Title
Acupressure for Fatigue in Ovarian Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2019 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Ovarian Cancer
Keywords
Acupressure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupressure plus standard of care
Arm Type
Experimental
Arm Description
Using AcuWand, participants will apply acupressure to points that are known to affect physiology. Participants will also receive standard of care.
Arm Title
Sham acupressure plus standard of care
Arm Type
Sham Comparator
Arm Description
Using AcuWand, participants will apply acupressure to points that are not known to affect physiology. Participants will also receive standard of care.
Arm Title
Standard of care
Arm Type
Other
Arm Description
Participants will receive standard of care only.
Intervention Type
Other
Intervention Name(s)
Acupressure
Intervention Description
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
Intervention Name(s)
Sham acupressure
Intervention Description
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
Intervention Name(s)
Standard of Care
Intervention Description
Fatigue management provided by participants' health care providers.
Primary Outcome Measure Information:
Title
Change in level of fatigue at week 6
Description
Self-reported on the Brief Fatigue Inventory (BFI)
Time Frame
Baseline to week 6
Title
Change in level of fatigue up to week 24
Description
Self-reported on the Brief Fatigue Inventory (BFI)
Time Frame
Baseline up to week 24
Secondary Outcome Measure Information:
Title
Change in quality of life at week 6
Description
Self-reported on the Functional Assessment of Cancer Therapy Ovarian (FACT-O)
Time Frame
Baseline to week 6
Title
Change in quality of life up to week 24
Description
Self-reported on the Functional Assessment of Cancer Therapy Ovarian (FACT-O)
Time Frame
Baseline up to week 24
Title
Change in sleep quality at week 6
Description
Self-reported on the Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Baseline to week 6
Title
Change in sleep quality up to week 24
Description
Self-reported on the Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Baseline up to week 24

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 at least 50% of their days for at least 3 months 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzanna M Zick, ND, MPH
Phone
734-998-9553
Email
szick@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanna M Zick, ND, MPH
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Rogel Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34119716
Citation
Zick SM, Kruger G, Harte S, Sen A, Harris RE, Pearce CL. Acupressure for Cancer-fatigue in Ovarian Cancer Survivor (AcuOva) Study: A community-based clinical trial study protocol examining the impact of self-acupressure on persistent cancer-related fatigue in ovarian cancer survivors. Contemp Clin Trials. 2021 Aug;107:106477. doi: 10.1016/j.cct.2021.106477. Epub 2021 Jun 10.
Results Reference
derived

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Acupressure for Fatigue in Ovarian Cancer Survivors

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