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| ID | Type | Description | Link |
|---|---|---|---|
| UM-ACMCN | |||
| EU-20971 |
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RATIONALE: Acupressure wristbands may prevent or reduce nausea caused by chemotherapy. It is not yet known whether acupressure wristbands are more effective than standard care in controlling acute and delayed nausea.
PURPOSE: This randomized phase III trial is studying acupressure wristbands to see how well they work compared with standard care in controlling nausea caused by chemotherapy.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to gender, age in years (16 to 24 vs >24 to 50 vs > 50), and level of emetogenic chemotherapy (high vs moderate vs low). Patients are randomized to 1 of 3 intervention arms:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| medical chart review | Other | |||
| questionnaire administration | Other | |||
| acupressure therapy | Procedure | |||
| quality-of-life assessment | Procedure | |||
| sham intervention | Procedure | |||
| standard follow-up care | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of nausea as assessed by the Rhodes Index of Nausea & Vomiting before and after chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and extent of acute and delayed nausea and vomiting by the MASCC Antiemesis Tool at day 10 of each course | ||
| Quality of life as assessed by FACT-G at baseline and at day 10 of each course |
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DISEASE CHARACTERISTICS:
Diagnosis of any cancer
Currently receiving adjuvant chemotherapy as outpatient
Acupressure wristband-naïve (in terms of never having tried such a wristband; may have seen or heard about such wristbands)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Alex Molassiotis, MD | University of Manchester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Manchester | Manchester | England | M13 9PL | United Kingdom |
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| Anxiety as assessed by the Hospital Anxiety & Depression Scale at baseline |
| Expectation for nausea and vomiting as assessed by the Patient Expectations of Nausea/Vomiting after each chemotherapy course |
| Measure of blindness (to intervention vs sham) assessed after chemotherapy |
| Sociodemographic and treatment characteristics assessed at baseline |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019050 | Acupressure |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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