Nausea
Conditions
Keywords
nausea, acupressure bands, relaxation
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.
Interventions
BEHAVIORALAcupressure 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.
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited at three cancer clinics from Feb. 6, 2006 to April 23, 2009
Participants by arm
| Arm | Count |
|---|---|
| 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. | 31 |
| 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. | 11 |
| 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. | 12 |
| 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. | 29 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 1 | 3 |
| Overall Study | Protocol Violation | 2 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Active Handout and Control Tape. | Control Handout and Active Tape. | Control Handout and Control Tape. | Active Handout and Active Tape. | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 2 Participants | 5 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 11 Participants | 29 Participants | 24 Participants | 73 Participants |
| Age, Continuous | 53.9 years STANDARD_DEVIATION 9.4 | 49.1 years STANDARD_DEVIATION 11.1 | 48.2 years STANDARD_DEVIATION 10.5 | 55.4 years STANDARD_DEVIATION 9.9 | 51.6 years STANDARD_DEVIATION 10.6 |
| Region of Enrollment United States | 11 participants | 12 participants | 31 participants | 29 participants | 83 participants |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 31 Participants | 29 Participants | 83 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 11 | 0 / 12 | 0 / 29 |
| serious Total, serious adverse events | 0 / 31 | 0 / 11 | 0 / 12 | 0 / 29 |
Outcome results
Primary
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.
Time frame: Five days
Population: All patients who did not have protocol violations who provided evaluable data were included in the analyses. No data imputation was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Handout and Control Tape. | Five-day Nausea Diary | 2.0 Units on scale | Standard Deviation 1.1 |
| Active Handout and Control Tape. | Five-day Nausea Diary | 2.1 Units on scale | Standard Deviation 1.7 |
| Control Handout and Active Tape. | Five-day Nausea Diary | 2.1 Units on scale | Standard Deviation 0.9 |
| Active Handout and Active Tape. | Five-day Nausea Diary | 1.9 Units on scale | Standard Deviation 1.1 |
Comparison: The primary analyses consisted of calculating means and standard deviations on nausea for the four study arms to generate an effect size estimate for a later R01. We also planned to use a 2 x 2 (i.e., two levels of expectancy CDs and two levels of expectancy handouts) full factorial analysis of variance (ANOVA) to examine the efficacy of these two methods of expectancy enhancement in reducing Average Nausea as well as any interaction effects.p-value: 0.932ANOVA
Secondary
Health Related Quality of Life
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.
Time frame: 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Handout and Control Tape. | Health Related Quality of Life | 75.2 Units on scale | Standard Deviation 15.2 |
| Active Handout and Control Tape. | Health Related Quality of Life | 74.6 Units on scale | Standard Deviation 14.9 |
| Control Handout and Active Tape. | Health Related Quality of Life | 70.9 Units on scale | Standard Deviation 13.6 |
| Active Handout and Active Tape. | Health Related Quality of Life | 75.9 Units on scale | Standard Deviation 17.2 |
Comparison: ANOVA to compare means of the four groups was used.p-value: 0.84ANOVA