Acupressure and Relaxation for Nausea Control

Phase 1

Completed

Conditions: Nausea

Interventions: Behavioral: Acupressure expectancy enhancement

Registration Number: NCT00243269

Lead Sponsor: University of Rochester

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. 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 83

Inclusion Criteria

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

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	Acupressure expectancy enhancement	Expectancy enhancing handout and expectancy enhancing tape
3	Acupressure expectancy enhancement	Expectancy neutral handout and expectancy enhancing tape
1	Acupressure expectancy enhancement	Expectancy neutral handout and expectancy neutral tape
2	Acupressure expectancy enhancement	Expectancy enhancing handout and expectancy neutral tape

Primary Outcome Measures

Name	Time	Method
Five-day Nausea Diary	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

Name	Time	Method
Health Related Quality of Life	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.