Alternative Approaches for Nausea Control

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2017-05-16

Brief Summary

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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

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Detailed Description

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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

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Nausea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1 - Standard Care Only

Patients will receive standard care only

Group Type NO_INTERVENTION

No interventions assigned to this group

Arm 2 - Expectancy-neutral Arm

Patients receive:

1. Expectancy-neutral handout
2. Expectancy-neutral MP3
3. Acupressure bands

Group Type OTHER

Acupressure bands

Intervention Type DEVICE

Bilateral acupressure wrist bands

Expectancy-neutral handout

Intervention Type OTHER

The expectancy neutral handout has neutral information regarding the acupressure bands

Expectancy-neutral MP3

Intervention Type BEHAVIORAL

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.

Arm 3 - Expectancy-enhancing Arm

Patients receive:

1. Expectancy-enhancing handout
2. Expectancy-enhancing MP3
3. Acupressure bands

Group Type EXPERIMENTAL

Acupressure bands

Intervention Type DEVICE

Bilateral acupressure wrist bands

Expectancy-enhancing handout

Intervention Type OTHER

The expectancy enhancing handout has expectancy-enhancing information regarding the acupressure bands

Expectancy-enhancing MP3

Intervention Type BEHAVIORAL

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.

Interventions

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Acupressure bands

Bilateral acupressure wrist bands

Intervention Type DEVICE

Expectancy-neutral handout

The expectancy neutral handout has neutral information regarding the acupressure bands

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Expectancy-enhancing handout

The expectancy enhancing handout has expectancy-enhancing information regarding the acupressure bands

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Be female.
* Have a diagnosis of breast cancer, any stage.
* Be chemotherapy naïve and about to begin her first course of chemotherapy.
* Be scheduled to receive one of the following four common chemotherapy regimens with the specified antiemetic regimen. They are:

1. Chemotherapy regimen: Doxorubicin/cyclophosphamide. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 \& 3.
2. Chemotherapy regimen: Doxorubicin/cyclophosphamide/docetaxel. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 \& 3.
3. Chemotherapy regimen: Docetaxel/carboplatin. Antiemetic regimen: Palonosetron on Day 1 + dexamethasone on Days 1, 2, \& 3.
4. Chemotherapy regimen: Docetaxel/cyclophosphamide. Antiemetic regimen: Palonosetron on Day 1 + dexamethasone on Days 1, 2, \& 3.

Note: Fosaprepitant will be allowed in place of aprepitant, and either granisetron or ondansetron, on one or more days, will be allowed in place of palonosetron.

* Have a response of \> 3 or greater on a question assessing expected nausea as assessed on a 5-point Likert-scale anchored at one end by 1 = "I am certain I WILL NOT have this," and at the other end by 5 = "I am certain I WILL have this."
* Be able to read English (since the assessment materials are in printed format).
* Be 18 years of age or older and give written informed consent.

Exclusion Criteria

* Have clinical evidence of lymphedema, current bowel obstruction, or symptomatic brain metastases, as determined by their treating oncologist.
* Be receiving concurrent radiotherapy or interferon.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No