Alternative Approaches for Nausea Control
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
patient report nausea diary
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.
Joseph A Roscoe, Ph.D.
University of Rochester
United States: Data and Safety Monitoring Board
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|University of Rochester James P. Wilmot Cancer Center||Rochester, New York 14642|
|Hematology-Oncology Associates of Central New York||East Syracuse, New York 13057|
|Rochester General Hospital's Lipson Cancer and Blood Center||Rochester, New York 14621|