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Study Results
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Acupressure and Relaxation for Nausea Control
This study has been completed.
Study NCT00243269   Information provided by University of Rochester

First Received on October 19, 2005.   Last Updated on December 20, 2010   History of Changes
Results First Received: March 22, 2010  
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
Condition: Nausea
Intervention: Behavioral: Acupressure expectancy enhancement

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited at three cancer clinics from Feb. 6, 2006 to April 23, 2009

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control Handout and Control Tape. Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, “Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study.” Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
Active Handout and Control Tape.

Patients received two acupressure bands.

Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, “Wear Seabands for up to five days as needed to prevent or alleviate nausea.” Patients’ names were not on the prescription.

Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
Control Handout and Active Tape.

Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.

Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients’ beliefs that the acupressure bands would be effective by focusing patients’ attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well.
Active Handout and Active Tape.

Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.

Patients received the same expectancy-enhancing CD given to patients in Arm 3.

Participant Flow:   Overall Study
    Control Handout and Control Tape.     Active Handout and Control Tape.     Control Handout and Active Tape.     Active Handout and Active Tape.  
STARTED     31     11     12     29  
COMPLETED     28     10     11     25  
NOT COMPLETED     3     1     1     4  
Protocol Violation                 2                 1                 0                 1  
Lost to Follow-up                 1                 0                 1                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Control Handout and Control Tape. Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, “Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study.” Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
Active Handout and Control Tape.

Patients received two acupressure bands.

Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, “Wear Seabands for up to five days as needed to prevent or alleviate nausea.” Patients’ names were not on the prescription.

Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
Control Handout and Active Tape.

Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.

Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients’ beliefs that the acupressure bands would be effective by focusing patients’ attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well.
Active Handout and Active Tape.

Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.

Patients received the same expectancy-enhancing CD given to patients in Arm 3.

Baseline Measures
    Control Handout and Control Tape.     Active Handout and Control Tape.     Control Handout and Active Tape.     Active Handout and Active Tape.     Total  
Number of Participants  
[units: participants]
 		  31     11     12     29     83  
Age  
[units: participants]
 		         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     29     9     11     24     73  
>=65 years     2     2     1     5     10  
Age  
[units: years]
Mean ± Standard Deviation 		  48.2  ± 10.5     53.9  ± 9.4     49.1  ± 11.1     55.4  ± 9.9     51.6  ± 10.6  
Gender  
[units: participants]
 		         
Female     31     11     12     29     83  
Male     0     0     0     0     0  
Region of Enrollment  
[units: participants]
 		         
United States     31     11     12     29     83  



  Outcome Measures
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1.  Primary:   Five-day Nausea Diary   [ Time Frame: Five days ]
  Show Outcome Measure 1

2.  Secondary:   Health Related Quality of Life   [ Time Frame: 5 days ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations include a small sample size and the fact that we ceased recruitment to two of the treatment arms and changed our planned primary analysis mid-study based upon an interim analysis that was not specified at the time the study began.  


Results Point of Contact:  
Name/Title: Joseph Roscoe PhD
Organization: University of Rochester
phone: 585 275-9962
e-mail: joseph_roscoe@urmc.rochester.edu


Publications of Results:
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





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