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: Neutral handout; Arm 2: Neutral handout + control relaxation MP3 + acupressure bands; Arm 3: Expectancy-enhancing handout + expectancy-enhancing relaxation MP3 + acupressure bands.
Hypothesis: Acupressure bands with expectancy-enhancing supplementary material will be more effective in controlling chemotherapy-induced nausea than acupressure bands with neutral supplementary material.
Device: Acupressure bands
Other: Expectancy neutral handout
Behavioral: Expectancy neutral MP3
Other: Expectancy enhancing handout
Behavioral: Expectancy enhancing 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 an expectancy neutral thank-you note that has no mention of acupressure bands.
Patients will receive the expectancy neutral handout, the expectancy neutral 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: Expectancy neutral handout
The expectancy neutral handout given to patients will simply thank patients for participating in the study and includes a piece of paper that says, "Use the acupressure bands in addition to your regular medication."Behavioral: Expectancy neutral 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 expectancy enhancing handout, the expectancy enhancing 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: Expectancy enhancing handout
There are two parts of the expectancy enhancing handout. Part 1 is a handout that provides evidence that the bands may be helpful for reducing nausea. Part 2 is a prescription signed by a medical oncologist and has the instruction, "Wear Seabands for up to five days as needed to prevent or alleviate nausea."Behavioral: Expectancy enhancing 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 additional language inserted concerning efficacy of the acupressure bands and control of nausea.
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: Neutral handout; Arm 2: Neutral handout + control relaxation MP3 + acupressure bands; Arm 3: Expectancy-enhancing handout + expectancy-enhancing relaxation MP3 + acupressure bands. The investigators hypothesize that acupressure bands provided with expectancy-enhancing materials will be more effective in controlling chemotherapy-induced nausea than acupressure bands provided with neutral materials.
|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 firstname.lastname@example.org|
|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 email@example.com|
|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|