NCT01695993

Alternative Approaches for Nausea Control

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure bands; Arm 3: Expectancy-enhancing handout + Expectancy-enhancing MP3 + acupressure bands. Hypothesis: Acupressure bands provided with the relaxation MP3 will be effective in controlling chemotherapy-induced nausea

Detailed description

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: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure bands; Arm 3: Expectancy-enhancing handout + Expectancy-enhancing 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.

Conditions

• Nausea

Interventions

Type	Name	Description
DEVICE	Acupressure bands	Bilateral acupressure wrist bands
OTHER	Expectancy-neutral handout	The expectancy neutral handout has neutral information regarding the acupressure bands
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.
OTHER	Expectancy-enhancing handout	The expectancy enhancing handout has expectancy-enhancing information regarding the acupressure bands
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. It also has expectancy-enhancing information regarding the acupressure bands.

Timeline

• Start date: 2012-11-01
• Primary completion: 2017-05-16
• Completion: 2017-05-16
• First posted: 2012-09-28
• Last updated: 2018-06-26
• Results posted: 2018-05-25

Locations

4 sites across 1 country: United States