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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 19, 2005 | ||||
| Last Updated Date | October 13, 2006 | ||||
| Start Date ICMJE | November 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
1- Mean Nausea severity | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00243269 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
2- Health Related Quality of Life | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Acupressure and Relaxation for Nausea Control | ||||
| Official Title ICMJE | Acupressure and Relaxation for Nausea Control | ||||
| Brief Summary | This study hypothesizes that patients receiving efficacy enhancing information about the acupressure bands will expect less treatment-related nausea, which will subsequently result in less treatment-related nausea compared to patients who do not receive such information. This study extends prior research by utilizing a randomized controlled trial in a clinical environment to examine the efficacy of an intervention that is specifically designed to reduce patients’ response expectancies concerning nausea development from cancer treatments, and, thereby, reduce nausea. The objectives of this study are as follow:
To provide preliminary data on whether a two-tiered strategy to increase patients’ expectancies for nausea prevention and/or management is more effective than a single-tiered strategy in reducing chemotherapy- induced nausea. |
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| Detailed Description | This study hypothesizes that patients receiving efficacy enhancing information about the acupressure bands will expect less treatment-related nausea, which will subsequently result in less treatment-related nausea compared to patients who do not receive such information. This study extends prior research by utilizing a randomized controlled trial in a clinical environment to examine the efficacy of an intervention that is specifically designed to reduce patients’ response expectancies concerning nausea development from cancer treatments, and, thereby, reduce nausea. The objectives of this study are as follow:
To provide preliminary data on whether a two-tiered strategy to increase patients’ expectancies for nausea prevention and/or management is more effective than a single-tiered strategy in reducing chemotherapy- induced nausea. The study contains the following arms:
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Nausea | ||||
| Intervention ICMJE | Behavioral: Acupressure expectancy enhancement | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 67 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00243269 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | U2905 | ||||
| Study Sponsor ICMJE | University of Rochester | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of Rochester | ||||
| Verification Date | October 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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