Clinical Trial: Alternative Approaches for Nausea Control

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Alternative Approaches for Nausea Control

Brief Summary:

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


Detailed Summary: 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.
Sponsor: University of Rochester

Current Primary Outcome: 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.


Original Primary Outcome: patient report nausea diary [ Time Frame: five days ]

Nausea and emesis will be measured by a patient report diary developed by Burish38 and Carey39 and 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 (20 total reporting times for each five-day period). 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 as part of the five-day diary for later exploratory analyses. We have used this scale in previous studies,7,13,40 so we will be able to compare current findings with results of our previous research.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Rochester

Dates:
Date Received: September 26, 2012
Date Started: November 2012
Date Completion: May 31, 2017
Last Updated: March 23, 2017
Last Verified: March 2017