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| ID | Type | Description | Link |
|---|---|---|---|
| R01AT007474-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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216 Chemotherapy-naïve, female breast cancer patients about to begin chemotherapy and who expect to have nausea, will be entered. Participants will be randomized to one of three study arms: Arm 1: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure bands; Arm 3: Expectancy-enhancing handout + Expectancy-enhancing MP3 + acupressure bands.
Hypothesis: Acupressure bands provided with the relaxation MP3 will be effective in controlling chemotherapy-induced nausea
Earlier research has shown that the effectiveness of acupressure bands in reducing nausea could be enhanced by boosting patients' expectations of the bands' efficacy. The present study seeks to confirm and extend these findings in a multi-site, 3-arm, randomized, controlled study of 216 breast cancer patients beginning chemotherapy who expect to have nausea. All patients will receive a standardized antiemetic regimen. Arm 1: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure bands; Arm 3: Expectancy-enhancing handout + Expectancy-enhancing MP3 + acupressure bands. The investigators hypothesize that acupressure bands provided with the relaxation MP3 will be effective in controlling chemotherapy-induced nausea. The two versions of the handout and MP3 are being examined to determine what is the most effective way to deliver the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Standard Care Only | No Intervention | Patients will receive standard care only | |
| Arm 2 - Expectancy-neutral Arm | Other | Patients receive:
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| Arm 3 - Expectancy-enhancing Arm | Experimental | Patients receive:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupressure bands | Device | Bilateral acupressure wrist bands |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Report Nausea Diary | Nausea and will be measured by a patient report diary completed by patients over a five-day period. Each day is divided into four segments (morning, afternoon, evening, night) in which patients report the severity of nausea and number of vomiting episodes for each period of the day. Severity of nausea is 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 outcome variable for the primary analysis was greatest reported nausea from the five day period. | five days |
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Inclusion Criteria:
Be female.
Have a diagnosis of breast cancer, any stage.
Be chemotherapy naïve and about to begin her first course of chemotherapy.
Be scheduled to receive one of the following four common chemotherapy regimens with the specified antiemetic regimen. They are:
Note: Fosaprepitant will be allowed in place of aprepitant, and either granisetron or ondansetron, on one or more days, will be allowed in place of palonosetron.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph A Roscoe, Ph.D. | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States | ||
| Hematology-Oncology Associates of Central New York |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | Patients receive standard care only |
| FG001 | Arm 2 | Handout without expectancy- enhancing component Relaxation MP3 without expectancy-enhancing component - Acupressure bands |
| FG002 | Arm 3 | Handout with expectancy- enhancing component Relaxation MP3 with expectancy- enhancing component Acupressure bands |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | Patients will receive only standard care |
| BG001 | Arm 2 |
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Report Nausea Diary | Nausea and will be measured by a patient report diary completed by patients over a five-day period. Each day is divided into four segments (morning, afternoon, evening, night) in which patients report the severity of nausea and number of vomiting episodes for each period of the day. Severity of nausea is 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 outcome variable for the primary analysis was greatest reported nausea from the five day period. | Posted | Mean | Standard Deviation | units on a scale | five days |
|
two months
We used a standard definition for adverse events, but because this was a minimal risk study, our IRB required us to report and record only SAEs that were possibly, probably, or definitely related to the study intervention. See Section 5.7.1.1 of the protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Patients will receive only standard care | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph A. Roscoe, PhD Associate Research Professor | University of Rochester Medical Center | 585 275-9962 | joseph_roscoe@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 26, 2016 | Mar 23, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Expectancy-neutral handout | Other | The expectancy neutral handout has neutral information regarding the acupressure bands |
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| Expectancy-neutral MP3 | Behavioral | Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery. |
|
| Expectancy-enhancing handout | Other | The expectancy enhancing handout has expectancy-enhancing information regarding the acupressure bands |
|
| Expectancy-enhancing MP3 | Behavioral | Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery. It also has expectancy-enhancing information regarding the acupressure bands. |
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| East Syracuse |
| New York |
| 13057 |
| United States |
| Rochester General Hospital's Lipson Cancer and Blood Center | Rochester | New York | 14621 | United States |
| University of Rochester James P. Wilmot Cancer Center | Rochester | New York | 14642 | United States |
| To ill to continue |
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| Changed Medical Facility |
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| BG002 | Arm 3 |
|
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG002 | Expectancy-Enhancing Condition |
|
|
|
|
| 76 |
| 0 |
| 76 |
| 0 |
| 76 |
| EG001 | Arm 2 | Patients receive:
| 0 | 75 | 0 | 75 | 0 | 75 |
| EG002 | Arm 3 | Patients receive:
| 0 | 75 | 0 | 75 | 0 | 75 |
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