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This clinicaI trial is being done to determine if acupressure is helpful to reduce anxiety related to chemotherapy, compared with "sham" (or placebo) acupressure in patients with cancer. Anxiety, experienced by many patients with cancer, can be related to chemotherapy and may contribute to other symptoms, such as nausea and poor quality of life. Some patients diagnosed with cancer express interest in non-medicine ways to manage symptoms. Acupressure is the application of non-invasive finger pressure along energy points throughout the body in order to relieve pain and induce a feeling of well-being. Previous research has shown that acupressure can help both adults and children with their anxiety in certain situations, such as after surgery. Patients can be taught how to do the acupressure on themselves, making this an intervention that can be done anywhere. Acupressure is well tolerated with minimal reports of adverse reactions. Undergoing acupressure may be effective in reducing anxiety in cancer patients receiving chemotherapy.
PRIMARY OBJECTIVE:
I. To test the efficacy of a nurse-applied acupressure intervention for anxiety associated with active cancer-directed therapy.
SECONDARY OBJECTIVES:
I. To test the efficacy of a patient-applied acupressure intervention for anxiety associated with active cancer-directed therapy.
II. To assess whether acupressure appears to improve nausea related to cancer and cancer-directed therapy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo true acupressure over 10 minutes on study. Patients that choose to learn self-administration acupressure at home receive educational information and undergo self-administration acupressure sessions at least twice daily (BID) for seven days.
ARM II: Patients undergo sham acupressure over 10 minutes on study. Patients that choose to learn self-administration acupressure at home receive educational information and undergo self-administration acupressure sessions at least BID for seven days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (true acupressure) | Experimental | Patients undergo true acupressure over 10 minutes on study. Patients that choose to learn self-administration acupressure at home receive educational information and undergo self-administration acupressure sessions at least BID for seven days. |
|
| Arm II (sham acupressure) | Sham Comparator | Patients undergo sham acupressure over 10 minutes on study. Patients that choose to learn self-administration acupressure at home receive educational information and undergo self-administration acupressure sessions at least BID for seven days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupressure Therapy | Procedure | Undergo true acupressure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in acute anxiety | Will be compared between treatment groups. This will be measured by changes in responses to a single item, "Please rate the following symptoms, based on how you feel at the current time (please indicate the one most correct response)," with responses provided on a Likert scale from 0 (no anxiety) to 10 (worst possible anxiety). | Up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Associations between changes in anxiety and demographic variables | Demographic variables, including age, gender identity, race/ethnicity, cancer type, cancer stage, and cancer therapy type, will be compared with answers to anxiety question specified in Outcome 1. | Up to 2 weeks |
| Efficacy of self-administered acupressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu | |
| Jennifer Manggaard | Contact | 507-255-7768 | Manggaard.Jennifer@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Cathcart-Rake, MD | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Patients are blinded during intervention only and unblinded following intervention completion
| Acupressure Therapy - placebo | Procedure | Undergo sham acupressure |
|
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| Acupressure Therapy - self-administered | Procedure | Undergo self-administered acupressure |
|
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| Health Promotion and Education | Other | Receive educational handouts |
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| Survey Administration | Other | Ancillary studies |
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Assessed by the number of participants in each arm (true vs sham) who are willing to complete self-administered acupressure. |
| Up to 2 weeks |
| Changes in anxiety-related symptoms | Assessed using an anxiety questionnaire administered at baseline and post-intervention. Seven items (anxiety, nausea, pain, wellbeing, relaxation, worry, and distress) are rated on a scale of 0 (strongly disagree) to 10 (strongly agree). | Up to 2 weeks |
| ID | Term |
|---|---|
| D019050 | Acupressure |
| D006293 | Health Promotion |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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