Acupressure for Fatigue in Ovarian Cancer Survivors

Sponsor
University of Michigan Rogel Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03763838
Collaborator
(none)
165
1
3
35.8
4.6

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
  • Other: Acupressure
  • Other: Sham acupressure
  • Other: Standard of Care
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
165 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose:
Supportive Care
Official Title:
Acupressure for Fatigue in Ovarian Cancer Survivors
Actual Study Start Date :
Oct 7, 2019
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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

  1. Change in level of fatigue at week 6 [Baseline to week 6]

    Self-reported on the Brief Fatigue Inventory (BFI)

  2. 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

  1. Change in quality of life at week 6 [Baseline to week 6]

    Self-reported on the Functional Assessment of Cancer Therapy Ovarian (FACT-O)

  2. 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)

  3. Change in sleep quality at week 6 [Baseline to week 6]

    Self-reported on the Pittsburgh Sleep Quality Index (PSQI)

  4. 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

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier:
NCT03763838
Other Study ID Numbers:
  • UMCC 2018.130
  • HUM00143509
First Posted:
Dec 4, 2018
Last Update Posted:
Dec 17, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Michigan Rogel Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 17, 2021