Alternative Approaches for Nausea Control
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
Device: Acupressure bands
Other: Version 1 handout
Behavioral: Version 1 MP3
Other: Version 2 handout
Behavioral: Version 2 MP3
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Alternative Approaches for Nausea Control|
- patient report nausea diary [ Time Frame: five days ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||May 2017|
|Estimated Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
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.
Earlier research has shown that the effectiveness of acupressure bands in reducing nausea could be enhanced by boosting patients' expectations of the bands' efficacy. The present study seeks to confirm and extend these findings in a multi-site, 3-arm, randomized, controlled study of 216 breast cancer patients beginning chemotherapy who expect to have nausea. All patients will receive a standardized antiemetic regimen. Arm 1: Version 1 of Handout; Arm 2: Version 1 of handout + Version 1 relaxation MP3 + acupressure bands; Arm 3: Version 2 of handout + Version 2 of relaxation MP3 + acupressure bands. The investigators hypothesize that acupressure bands provided with the relaxation MP3 will be effective in controlling chemotherapy-induced nausea. The two versions of the handout and MP3 are being examined to determine what is the most effective way to deliver the intervention.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695993
|Contact: Jenine Hoefler, M.S.||585.276.3559||Jenine_Hoefler@URMC.Rochester.edu|
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Mary Lynne Tarquini, RN, BSN, CCRP Tarquini, RN, BSN, C 716-845-3008 email@example.com|
|Contact: Roswell Park 877-275-7724 ASKRPCI@RoswellPark.org|
|Principal Investigator: Tracey O'Connor, M.D.|
|Hematology-Oncology Associates of Central New York||Recruiting|
|East Syracuse, New York, United States, 13057|
|Contact: Coleen A Dillenbeck, MA, CCRC 315-472-7504 ext 1360 firstname.lastname@example.org|
|Principal Investigator: Jeffrey J. Kirshner, M.D.|
|University of Rochester James P. Wilmot Cancer Center||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Jenine Hoefler, M.S. 585-276-3559 Jenine_Hoefler@URMC.Rochester.edu|
|Principal Investigator: Joseph A Roscoe, Ph.D.|
|Rochester General Hospital's Lipson Cancer and Blood Center||Recruiting|
|Rochester, New York, United States, 14621|
|Contact: Caroline Andrews, MBA, CCRC 585-922-4040 Caroline.Andrews@rochestergeneral.org|
|Principal Investigator: Peter Bushunow, M.D.|
|Principal Investigator:||Joseph A Roscoe, Ph.D.||University of Rochester|