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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
171
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).
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.
Fatigue management provided by participants' health care providers.
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Change in Level of Fatigue at 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.
Time frame: Baseline to week 6
Change in Level of Fatigue 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.
Time frame: Baseline up to week 24
Change in Quality of Life at 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.
Time frame: Baseline to week 6
Change in Quality of Life 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.
Time frame: Baseline up to week 24
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Change in Sleep Quality at 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.
Time frame: Baseline to week 6
Change in Sleep Quality 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.
Time frame: Baseline up to week 24