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