Fatigue, Ovarian Cancer
Conditions
Keywords
Acupressure
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.
Interventions
OTHERAcupressure
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).
OTHERSham 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.
OTHERStandard of Care
Fatigue management provided by participants' health care providers.
Sponsors
University of Michigan Rogel Cancer Center
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, 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.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
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. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Level of Fatigue at Week 6 | Baseline to week 6 | Self-reported on the Brief Fatigue Inventory (BFI). The Brief Fatigue Inventory (BFI) uses a scale of 0 to 10 for each item, with 0 representing "no fatigue" and 10 representing "fatigue as bad as you can imagine". Scores are then categorized as mild (1-3), moderate (4-6), and severe (7-10). The global BFI score is calculated as the average of all items, and a score of 7 or greater is considered clinically significant. |
| Change in Level of Fatigue up to Week 24 | Baseline up to week 24 | Self-reported on the Brief Fatigue Inventory (BFI). The Brief Fatigue Inventory (BFI) uses a scale of 0 to 10 for each item, with 0 representing "no fatigue" and 10 representing "fatigue as bad as you can imagine". Scores are then categorized as mild (1-3), moderate (4-6), and severe (7-10). The global BFI score is calculated as the average of all items, and a score of 7 or greater is considered clinically significant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life at Week 6 | Baseline to week 6 | Self-reported on the Functional Assessment of Cancer Therapy Ovarian (FACT-O). The FACT-O is a questionnaire used to assess the quality of life in women with ovarian cancer. It includes 7 items, each scored from 0 to 4, with higher scores representing a more positive quality of life. Mean scores are reported by arm and timepoint. score range of 0-28. |
| 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). The FACT-O is a questionnaire used to assess the quality of life in women with ovarian cancer. It includes 7 items, each scored from 0 to 4, with higher scores representing a more positive quality of life. Mean scores are reported by arm and timepoint. score range of 0-28. |
| Change in Sleep Quality at Week 6 | Baseline to week 6 | Self-reported on the Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index (PSQI) yields a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. |
| Change in Sleep Quality up to Week 24 | Baseline up to week 24 | Self-reported on the Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index (PSQI) yields a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSuzanna M Zick, ND, MPH
University of Michigan
Participant flow
Pre-assignment details
Acupressure plus standard of care- 58 participants allocated, 5 participants did not start treatment. Sham plus standard of care- 58 participants allocated, 2 participants did not start treatment. Standard of care- 55 participants allocated, 4 participants did not start treatment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized | 55 years STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) White | 147 Participants |
| Region of Enrollment United States | 58 participants |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 56 | 0 / 51 |
| other Total, other adverse events | 0 / 53 | 1 / 56 | 0 / 51 |
| serious Total, serious adverse events | 0 / 53 | 1 / 56 | 0 / 51 |
Outcome results
None listed