Acupressure and Relaxation for Nausea Control

This study hypothesizes that patients receiving efficacy enhancing information about the acupressure bands will expect less treatment-related nausea, which will subsequently result in less treatment-related nausea compared to patients who do not receive such information.

This study extends prior research by utilizing a randomized controlled trial in a clinical environment to examine the efficacy of an intervention that is specifically designed to reduce patients' response expectancies concerning nausea development from cancer treatments, and, thereby, reduce nausea.

The objectives of this study are as follow:

1. To provide preliminary data on whether a two-tiered strategy to increase patients' expectancies for nausea prevention and/or management will result in reduced chemotherapy-induced nausea.
2. To provide preliminary data on whether a two-tiered strategy to increase patients' expectancies for nausea prevention and/or management will result in increased health-related quality of life (HRQL) in patients receiving emetogenic chemotherapy.

To provide preliminary data on whether a two-tiered strategy to increase patients' expectancies for nausea prevention and/or management is more effective than a single-tiered strategy in reducing chemotherapy- induced nausea.

Study Overview

• Status: Completed
• Conditions: Nausea
• Intervention / Treatment: Behavioral: Acupressure expectancy enhancement

Detailed Description

This study hypothesizes that patients receiving efficacy enhancing information about the acupressure bands will expect less treatment-related nausea, which will subsequently result in less treatment-related nausea compared to patients who do not receive such information.

This study extends prior research by utilizing a randomized controlled trial in a clinical environment to examine the efficacy of an intervention that is specifically designed to reduce patients' response expectancies concerning nausea development from cancer treatments, and, thereby, reduce nausea.

The objectives of this study are as follow:

1. To provide preliminary data on whether a two-tiered strategy to increase patients' expectancies for nausea prevention and/or management will result in reduced chemotherapy-induced nausea.
2. To provide preliminary data on whether a two-tiered strategy to increase patients' expectancies for nausea prevention and/or management will result in increased health-related quality of life (HRQL) in patients receiving emetogenic chemotherapy.

To provide preliminary data on whether a two-tiered strategy to increase patients' expectancies for nausea prevention and/or management is more effective than a single-tiered strategy in reducing chemotherapy- induced nausea.

The study contains the following arms:

1. Control handout and control tape.
2. Active handout and control tape.
3. Control handout and active tape.
4. Active handout and active tape.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester James P. Wilmot Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1) Have a diagnosis of breast cancer. 2) Be scheduled to receive a chemotherapy treatment containing doxorubicin (any dose) without concurrent radiotherapy or interferon. (Note: Chemotherapy agents in addition to doxorubicin may be given.) 3) Be 18 years of age or older. 3) Be chemotherapy naïve. 5) Be a female.

Exclusion Criteria:

1) Have clinical evidence of lymphedema, current bowel obstruction, or symptomatic brain metastases, as determined by their treating oncologist.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: 1; Expectancy neutral handout and expectancy neutral tape	Behavioral: Acupressure expectancy enhancement; This study hypothesizes that patients receiving efficacy enhancing information about the acupressure bands will expect less treatment-related nausea, which will subsequently result in less treatment-related nausea compared to patients who do not receive such information. This study extends prior research by utilizing a randomized controlled trial in a clinical environment to examine the efficacy of an intervention that is specifically designed to reduce patients' response expectancies concerning nausea development from cancer treatments, and, thereby, reduce nausea.; Other Names: 1 - Control handout and control tape; 2 - Active handout and control tape; 3 - Control handout and active tape; 4 - Active handout and active tape
EXPERIMENTAL: 2; Expectancy enhancing handout and expectancy neutral tape	Behavioral: Acupressure expectancy enhancement; This study hypothesizes that patients receiving efficacy enhancing information about the acupressure bands will expect less treatment-related nausea, which will subsequently result in less treatment-related nausea compared to patients who do not receive such information. This study extends prior research by utilizing a randomized controlled trial in a clinical environment to examine the efficacy of an intervention that is specifically designed to reduce patients' response expectancies concerning nausea development from cancer treatments, and, thereby, reduce nausea.; Other Names: 1 - Control handout and control tape; 2 - Active handout and control tape; 3 - Control handout and active tape; 4 - Active handout and active tape
EXPERIMENTAL: 3; Expectancy neutral handout and expectancy enhancing tape	Behavioral: Acupressure expectancy enhancement; This study hypothesizes that patients receiving efficacy enhancing information about the acupressure bands will expect less treatment-related nausea, which will subsequently result in less treatment-related nausea compared to patients who do not receive such information. This study extends prior research by utilizing a randomized controlled trial in a clinical environment to examine the efficacy of an intervention that is specifically designed to reduce patients' response expectancies concerning nausea development from cancer treatments, and, thereby, reduce nausea.; Other Names: 1 - Control handout and control tape; 2 - Active handout and control tape; 3 - Control handout and active tape; 4 - Active handout and active tape
EXPERIMENTAL: 4; Expectancy enhancing handout and expectancy enhancing tape	Behavioral: Acupressure expectancy enhancement; This study hypothesizes that patients receiving efficacy enhancing information about the acupressure bands will expect less treatment-related nausea, which will subsequently result in less treatment-related nausea compared to patients who do not receive such information. This study extends prior research by utilizing a randomized controlled trial in a clinical environment to examine the efficacy of an intervention that is specifically designed to reduce patients' response expectancies concerning nausea development from cancer treatments, and, thereby, reduce nausea.; Other Names: 1 - Control handout and control tape; 2 - Active handout and control tape; 3 - Control handout and active tape; 4 - Active handout and active tape

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Five-day Nausea Diary	Nausea was measured using a five-day patient report diary. Each day was divided into 4 sections: morning, afternoon, evening, and night. Patients reported severity of nausea for each period daily. Severity of nausea was 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." The description "Moderately nauseated" was centered on the scale below the 4. Average Nausea was the mean severity for the 20 reporting periods.	Five days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Related Quality of Life	Health-Related Quality of Life was assessed using the Functional Assessment of Cancer Therapy Scale - General (FACT-G). The FACT-G is a 28-item scale developed specifically for use in cancer clinical trials. Possible scores range from a low of 0 to a high of 112. Along with a total score representing HRQL, there are psychometrically validated subscales of physical, functional, social, and cognitive-emotional status. It has become one of the most commonly used measures in oncology, and we have used this scale in our previous studies.	5 days

Collaborators and Investigators

• Sponsor: University of Rochester

Publications and helpful links

General Publications

• Roscoe JA, O'Neill M, Jean-Pierre P, Heckler CE, Kaptchuk TJ, Bushunow P, Shayne M, Huston A, Qazi R, Smith B. An exploratory study on the effects of an expectancy manipulation on chemotherapy-related nausea. J Pain Symptom Manage. 2010 Sep;40(3):379-90. doi: 10.1016/j.jpainsymman.2009.12.024. Epub 2010 Jun 25.

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (ACTUAL): May 1, 2009
• Study Completion (ACTUAL): January 1, 2010

Study Registration Dates

• First Submitted: October 19, 2005
• First Submitted That Met QC Criteria: October 20, 2005
• First Posted (ESTIMATE): October 21, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): June 18, 2015
• Last Update Submitted That Met QC Criteria: May 21, 2015
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: nausea, acupressure bands, relaxation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea
• Other Study ID Numbers: U2905