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Acupressure and Relaxation for Nausea Control

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00243269
First Posted: October 21, 2005
Last Update Posted: June 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Joseph Roscoe, University of Rochester
  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:

  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.


Condition Intervention Phase
Nausea Behavioral: Acupressure expectancy enhancement Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Acupressure and Relaxation for Nausea Control

Resource links provided by NLM:


Further study details as provided by Joseph Roscoe, University of Rochester:

Primary Outcome Measures:
  • Five-day Nausea Diary [ Time Frame: Five days ]
    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 ]
    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:

  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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Joseph Roscoe, Research Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00243269     History of Changes
Other Study ID Numbers: U2905
First Submitted: October 19, 2005
First Posted: October 21, 2005
Results First Submitted: March 22, 2010
Results First Posted: January 21, 2011
Last Update Posted: June 18, 2015
Last Verified: March 2010

Keywords provided by Joseph Roscoe, University of Rochester:
nausea, acupressure bands, relaxation

Additional relevant MeSH terms:
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms