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What is the primary objective of this study?

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

Who is eligible to participate?

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Nausea

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:Acupressure bandsBilateral 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:Version 1 handoutThe Version 1 handout has less information concerning the acupressure bands than the Version 2 handout.

Behavioral:Version 1 MP3Patients 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:Version 2 handoutThe Version 2 handout has more information concerning the acupressure bands than the Version 1 handout.

Behavioral:Version 2 MP3Patients 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 some additional information in it regarding relaxation.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Arm 1Patients will receive only the Version 1 handout.

Arm 2Patients will receive the Version 1 handout, the Version 1 MP3, and acupressure bands.

Arm 3Patients will receive the Version 2 handout, the Version 2 MP3, and acupressure bands.

Study Status

Completed

Start Date: November 2012

Completed Date: May 16, 2017

Phase: N/A

Type: Interventional

Design:

Primary Outcome: patient report nausea diary

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Joseph A Roscoe, Ph.D.

Lead Sponsor: University of Rochester

Collaborator: National Center for Complementary and Integrative Health (NCCIH)

More information:https://clinicaltrials.gov/show/NCT01695993