Acupressure and Relaxation for Nausea Control

NCT00243269 | Completed Phase 1 Results DMC

• 1 other identifier: U2905
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

Conditions

Nausea

Keywords

nausea, acupressure bands, relaxation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Health Related Quality of Life

  5 days

Study Arms (4)

1

SHAM COMPARATOR

Expectancy neutral handout and expectancy neutral tape

Behavioral: Acupressure expectancy enhancement

2

EXPERIMENTAL

Expectancy enhancing handout and expectancy neutral tape

Behavioral: Acupressure expectancy enhancement

3

EXPERIMENTAL

Expectancy neutral handout and expectancy enhancing tape

Behavioral: Acupressure expectancy enhancement

4

EXPERIMENTAL

Expectancy enhancing handout and expectancy enhancing tape

Behavioral: Acupressure expectancy enhancement

Interventions

Acupressure expectancy enhancement BEHAVIORAL

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.

Also known as: 1 - Control handout and control tape, 2 - Active handout and control tape, 3 - Control handout and active tape, 4 - Active handout and active tape

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester James P. Wilmot Cancer Center

Rochester, New York, 14642, United States

Location

Related Publications (1)

• 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.

  PMID: 20579837 RESULT

MeSH Terms

Conditions

Nausea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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

• Title: Joseph Roscoe PhD
• Organization: University of Rochester

joseph_roscoe@urmc.rochester.edu

585 275-9962

Study Officials

• Joseph A Roscoe, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: October 19, 2005
• First Posted: October 21, 2005
• Study Start: November 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: January 1, 2010
• Last Updated: June 18, 2015
• Results First Posted: January 21, 2011

Record last verified: 2010-03

Locations

US (1)