Acupressure and Relaxation for Nausea Control - Full Text View

Sponsor:	University of Rochester
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00243269

Purpose

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:

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.
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.

Condition	Intervention	Phase
Nausea	Behavioral: Acupressure expectancy enhancement	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care
Official Title:	Acupressure and Relaxation for Nausea Control

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:

Five-day Nausea Diary [ Time Frame: Five days ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Health Related Quality of Life [ Time Frame: 5 days ] [ Designated as safety issue: No ]
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.

Enrollment:	83
Study Start Date:	November 2005
Study Completion Date:	January 2010
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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:

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.
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:

Control handout and control tape.
Active handout and control tape.
Control handout and active tape.
Active handout and active tape.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243269

Locations

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

Sponsors and Collaborators

University of Rochester

Investigators

Principal Investigator:

Joseph A Roscoe, PhD

University of Rochester

More Information

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. Epub 2010 Jun 25.

Responsible Party:	Joseph Roscoe, U Rochester
ClinicalTrials.gov Identifier:	NCT00243269 History of Changes
Other Study ID Numbers:	U2905
Study First Received:	October 19, 2005
Results First Received:	March 22, 2010
Last Updated:	December 20, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Rochester:

nausea, acupressure bands, relaxation

Additional relevant MeSH terms:

Nausea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on February 12, 2012