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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA151445 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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There are over 2 million breast cancer survivors today. Persistent Cancer-Related fatigue (PCRF), a state of being tired or weary, is one of the most common and distressing symptoms experienced by breast cancer (BC) survivors. Rates of significant PCRF in BC survivors range from 30% to 82% within the first 5-years of diagnosis and there are few treatment options for PCRF and these treatments require the availability of a trained practitioner, are associated with significant costs, pose a sizeable burden for the patient, or have unacceptable side-effects.
Acupressure is a technique derived from acupuncture, a component of Traditional Chinese Medicine. In acupressure, physical pressure is applied to acupuncture points by the hand, elbow, or with various devices to treat disease. Pilot studies have demonstrated that self-administered acupressure can significantly decrease PCRF by as much as 70% in cancer survivors. Acupressure can also have positive effects on sleep quality in cancer patients and other chronically ill populations. Self-administered acupressure is a non-toxic and inexpensive treatment that requires minimal instruction. It also requires little effort and time on the part of the patient to successfully complete. Thus, acupressure appears to be a promising treatment for PCRF and associated symptoms.
The investigators are conducting a single-blind, placebo controlled study to examine the specific effect of two opposing acupressure treatments compared to standard of care. The goal of this study is to determine the benefit of acupressure on treating persistent fatigue experience by many patients after completing their cancer treatment. Study patients will be randomized into one of three groups: two different types of acupressure or a standard of care arm. For those participants randomized to receive acupressure, the technique will be taught to them by a study nurse trained by an acupressure specialist. Participants will be asked to perform the acupressure daily over the next six weeks, during which time they will record their fatigue and be asked to wear an activity monitor to have their daily activity levels monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | Participants randomized into the standard of care group will be asked to continue following the instructions of the healthcare provider throughout the 10 week study period. They will not be asked to perform any study intervention. | |
| Relaxation Acupressure | Active Comparator | In addition to their standard of care, participants will be asked to apply pressure on each of 9 acupressure points (bilaterally where indicated) that have been carefully selected for their relaxing effect. (There are 5 acupoints with 4 of the acupoints performed on both the left and the right sides of the body giving a total of 9 points to stimulate. Each of the 9 acupoints will be stimulated for 3 minutes per point giving a total treatment time of 27 minutes done once daily over a period of 6 weeks followed by 4 weeks of intervention wash-out where the participant will be asked to perform no acupressure at all. |
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| Stimulating Acupressure | Active Comparator | In addition to their standard of care, participants will be asked to apply pressure on each of 9 acupressure points (bilaterally where indicated) that have been carefully selected for their excitatory effect. (There are 5 acupoints with 4 of the acupoints performed on both the left and the right sides of the body giving a total of 9 points to stimulate. There are 6 acupoints with 4 of the acupoints performed on both the left and the right sides of the body giving a total of 10 points to stimulate. Each of the 10 acupoints will be stimulated for 3 minutes per point giving a total treatment time of 30 minutes done once daily over a period of 6 weeks followed by 4 weeks of intervention wash-out where the participant will be asked to perform no acupressure at all. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relaxation Acupressure | Behavioral | Apply pressure on 9 relaxatory acupressure points for 3 minutes each once daily for a 6 week period, followed by a 4 week wash-out period. |
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| Measure | Description | Time Frame |
|---|---|---|
| The effect of 6-weeks of Relaxation Acupressure compared to a regime of Stimulating Acupressure or standard of care on fatigue. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of 6-weeks of Relaxation Acupressure compared to a regime of Stimulating Acupressure or standard of care on sleep quality | 12 weeks | |
| Onset and duration of acupressure effect. | 12 weeks |
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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 | Ann Arbor | Michigan | 48106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22909076 | Background | Zick SM, Wyatt GK, Murphy SL, Arnedt JT, Sen A, Harris RE. Acupressure for persistent cancer-related fatigue in breast cancer survivors (AcuCrft): a study protocol for a randomized controlled trial. BMC Complement Altern Med. 2012 Aug 21;12:132. doi: 10.1186/1472-6882-12-132. | |
| 27388752 | Derived | Zick SM, Sen A, Wyatt GK, Murphy SL, Arnedt JT, Harris RE. Investigation of 2 Types of Self-administered Acupressure for Persistent Cancer-Related Fatigue in Breast Cancer Survivors: A Randomized Clinical Trial. JAMA Oncol. 2016 Nov 1;2(11):1470-1476. doi: 10.1001/jamaoncol.2016.1867. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000077260 | Sleepiness |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Stimulating Acupressure | Behavioral | Apply pressure on 10 excitatory acupressure points for 3 minutes each once daily for a 6 week period, followed by a 4 week wash-out period. |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |