Alternative Approaches for Nausea Control
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|ClinicalTrials.gov Identifier: NCT01695993|
Recruitment Status : Completed
First Posted : September 28, 2012
Last Update Posted : January 16, 2018
216 Chemotherapy-naïve, female breast cancer patients about to begin chemotherapy and who expect to have nausea, will be entered. Participants will be randomized to one of three study arms: Arm 1: Version 1 handout; Arm 2: Version 1 handout + Version 1 relaxation MP3 + acupressure bands; Arm 3: Version 2 handout + Version 2 relaxation MP3 + acupressure bands.
Hypothesis: Acupressure bands provided with the relaxation MP3 will be effective in controlling chemotherapy-induced nausea
|Condition or disease||Intervention/treatment||Phase|
|Nausea||Device: Acupressure bands Other: Version 1 handout Behavioral: Version 1 MP3 Other: Version 2 handout Behavioral: Version 2 MP3||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||242 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Alternative Approaches for Nausea Control|
|Actual Study Start Date :||November 2012|
|Actual Primary Completion Date :||May 16, 2017|
|Actual Study Completion Date :||May 16, 2017|
No Intervention: Arm 1
Patients will receive only the Version 1 handout.
Patients will receive the Version 1 handout, the Version 1 MP3, and acupressure bands.
Device: Acupressure bands
Bilateral acupressure wrist bands (Sea-Band International, England), given to patients in trial Arms 2 and 3, are widely available and inexpensive (under $6.00 a pair).Other: Version 1 handout
The Version 1 handout has less information concerning the acupressure bands than the Version 2 handout.Behavioral: Version 1 MP3
Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery.
Experimental: Arm 3
Patients will receive the Version 2 handout, the Version 2 MP3, and acupressure bands.
Device: Acupressure bands
Bilateral acupressure wrist bands (Sea-Band International, England), given to patients in trial Arms 2 and 3, are widely available and inexpensive (under $6.00 a pair).Other: Version 2 handout
The Version 2 handout has more information concerning the acupressure bands than the Version 1 handout.Behavioral: Version 2 MP3
Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery. The MP3 (for subjects randomized to Arm 3) has some additional information in it regarding relaxation.
- patient report nausea diary [ Time Frame: five days ]Nausea and emesis will be measured by a patient report diary completed by patients over a five-day period. Each day is divided into four segments (morning, afternoon, evening, night) in which patients report the severity of nausea and number of vomiting episodes for each period of the day. Severity of nausea is assessed on a 7-point rating scale, anchored at one end by 1 = "Not at all nauseated" and at the other end by 7 = "Extremely nauseated." Vomiting episodes will be recorded for the same time intervals.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695993
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Hematology-Oncology Associates of Central New York|
|East Syracuse, New York, United States, 13057|
|Rochester General Hospital's Lipson Cancer and Blood Center|
|Rochester, New York, United States, 14621|
|University of Rochester James P. Wilmot Cancer Center|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Joseph A Roscoe, Ph.D.||University of Rochester|