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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00143509 | Other Identifier | University of Michigan | |
| W81XWH1810180 | Other Grant/Funding Number | Defense, Department of-Army, Department of the |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupressure plus standard of care | Experimental | Using AcuWand, participants will apply acupressure to points that are known to affect physiology. Participants will also receive standard of care. |
|
| Sham acupressure plus standard of care | Sham Comparator | Using AcuWand, participants will apply acupressure to points that are not known to affect physiology. Participants will also receive standard of care. |
|
| Standard of care | Other | Participants will receive standard of care only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupressure | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline up to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanna M Zick, ND, MPH | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41642626 | Derived | Zick SM, Chen D, Harris RE, Kruger G, Runyon A, Sen A, Snyder S, Pearce CL. Self-Acupressure for Fatigue in Patients Surviving Ovarian Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2556357. doi: 10.1001/jamanetworkopen.2025.56357. | |
| 34119716 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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). Standard of Care: Fatigue management provided by participants' health care providers. |
| FG001 | 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. 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. Standard of Care: Fatigue management provided by participants' health care providers. |
| FG002 | Standard of Care | Participants will receive standard of care only. Standard of Care: Fatigue management provided by participants' health care providers. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Including all subjects who were randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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). Standard of Care: Fatigue management provided by participants' health care providers. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | evaluable patients at week 6 | Posted | Mean | 95% Confidence Interval | mean score | Baseline to week 6 |
|
All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through the follow up visit at week 6.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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). Standard of Care: Fatigue management provided by participants' health care providers. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Guillain-Barré syndrome (GBS) | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rheumatoid arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin | University of Michigan Rogel Cancer Center | 734-936-9499 | ClinicalTrialsgov_CCAdmin@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2025 | Aug 12, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 13, 2023 | Jun 19, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D019050 | Acupressure |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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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.
|
| Sham acupressure | Other | 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. |
|
| Standard of Care | Other | Fatigue management provided by participants' health care providers. |
|
| 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. | Baseline up to week 24 |
| 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. | 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. | Baseline up to week 24 |
| Adverse Event |
|
| Disease Reoccurrence |
|
| participants did not start treatment. |
|
| BG001 | 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. 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. Standard of Care: Fatigue management provided by participants' health care providers. |
| BG002 | Standard of Care | Participants will receive standard of care only. Standard of Care: Fatigue management provided by participants' health care providers. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. 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. Standard of Care: Fatigue management provided by participants' health care providers. |
| OG002 | Standard of Care | Participants will receive standard of care only. Standard of Care: Fatigue management provided by participants' health care providers. |
|
|
| Primary | 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. | evaluable patients at 24 weeks | Posted | Mean | 95% Confidence Interval | mean score | Baseline up to week 24 |
|
|
|
| Secondary | 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. | number of patients evaluable at 6 weeks | Posted | Mean | 95% Confidence Interval | mean score | Baseline to week 6 |
|
|
|
| Secondary | 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. | Number of evaluable patients at 24 weeks | Posted | Mean | 95% Confidence Interval | mean score | Baseline up to week 24 |
|
|
|
| Secondary | 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. | evaluable patients at 6 weeks | Posted | Mean | 95% Confidence Interval | mean score | Baseline to week 6 |
|
|
|
| Secondary | 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. | evaluable patients at 24 weeks | Posted | Mean | 95% Confidence Interval | mean score | Baseline up to week 24 |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | 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. 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. Standard of Care: Fatigue management provided by participants' health care providers. | 0 | 56 | 1 | 56 | 1 | 56 |
| EG002 | Standard of Care | Participants will receive standard of care only. Standard of Care: Fatigue management provided by participants' health care providers. | 0 | 51 | 0 | 51 | 0 | 51 |
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| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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