Acupressure for Fatigue in Ovarian Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Change in Level of Fatigue at Week 6
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Acupressure (Other)
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.
干预措施: Standard of Care (Other)
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.
干预措施: Sham acupressure (Other)
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.
干预措施: Standard of Care (Other)
Standard of care
Participants will receive standard of care only.
干预措施: Standard of Care (Other)
结局指标
主要结局
Change in Level of Fatigue at Week 6
时间窗: 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
时间窗: 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.
次要结局
- Change in Quality of Life at Week 6(Baseline to week 6)
- Change in Quality of Life up to Week 24(Baseline up to week 24)
- Change in Sleep Quality at Week 6(Baseline to week 6)
- Change in Sleep Quality up to Week 24(Baseline up to week 24)