AroMatherapy for Blood and Marrow Transplant PatIENTs (AMBIENT)

Study Overview
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Brief Summary
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The study is comparing the difference between the use of Elequil Aromatabs versus standard of care practice treatments on Blood Marrow Transplantation patients.

Detailed Description
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The primary objective is to examine whether there are differences in the level of anxiety and nausea between patients in the treatment and control groups. The secondary objective is to compare the number of as needed (PRN) antiemetics and anxiolytics, as well as the duration of prolonged standardized antiemetic and anxiolytic regimen for the treatment and control cohorts. The sample size of 200 patients is anticipated to be enrolled over a period of 1 year. A total of 50 patients will be enrolled in each of the four groups The enrollment procedure will begin with a screening of patients who are admitted within 24 hours of admission for blood and marrow transplantation conditioning to evaluate if they meet the inclusion criteria. Patients who meet inclusion criteria will be offered an opportunity to participate in the study. The patient will complete an informed consent form, then assessed to identify their predominant symptom:anxiety or nausea. Based on the patients' primary symptom, they will be randomized into either control or treatment group for a total of four groups (nausea treatment, nausea control, anxiety treatment, and anxiety control). The study will be using a Wei's Urn algorithm for the randomization sequence. The randomization sequence and patient information will be stored in a protected SharePoint folder between the 8PE and 8PW nurses enrolled with the Institutional Review Board as study staff. Patients enrolled in the nausea control/treatment group will be required to complete a Generalized Anxiety Disorder 7-Item Scale (GAD-7) form to determine the baseline of anxiety.

Official Title
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AroMatherapy for Blood and Marrow Transplant PatIENTs (AMBIENT)

Conditions
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Anxiety, Nausea, Vomiting

Intervention / Treatment
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* Other: Elequil Aromatabs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult blood and marrow transplant patients admitted to 8 Pavilion East Blood and Marrow Transplant and 8 Pavilion West Blood and Marrow Transplant for autologous and allogeneic blood and marrow transplant conditioning (chemotherapy and/or radiation therapy) and transplant cell infusion Ages 22 and above. Adults ages 18-21 are admitted under the pediatric service and are not admitted to 8PE and 8PW Patients with blood and marrow transplant conditioning induced nausea and vomiting- Patients expressing feeling of anxiety English and Spanish speaking only Patients enrolled in other research studies that allow them to participate Exclusion Criteria: Patients with known allergy to lavender Patient with known allergy to orange/peppermint Patients less than 22 years Patients with olfactory/sinus impairment Patients unable to give written informed consent Patients admitted for inpatient conditioning but receiving transplant cell infusion in the outpatient setting

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients receiving Elequil Aromatabs(treatment cohort) and patients receiving Standard of care (control cohort). In addition, patients will be receiving PRN antiemetic or PRN anxiolytics
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anxiety Arm (Treatment)<br>Patient will receive Elequil Aromatabs | Other: Elequil Aromatabs<br>* There will be a variety of different Aromatabs such as orange/peppermint or lavender<br>|
| Experimental: Nausea/Vomiting Arm (Treatment)<br>Patient will receive Elequil Aromatabs | Other: Elequil Aromatabs<br>* There will be a variety of different Aromatabs such as orange/peppermint or lavender<br>|
| No Intervention: Nausea/Vomiting Arm (Control)<br>Patient will not receive Elequil Aromatabs | |
| No Intervention: Anxiety Arm (Control)<br>Patient will not receive Elequil Aromatabs | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Using the Halpin 0-to-5 Nausea and Vomiting Scales to document the degree of severity of patients' self-reported blood and marrow transplant conditioning regimen induced nausea and vomiting | Differences in the severity of nausea and vomiting between patients in the treatment and control groups | 12-hour intervals for a year | 
| Using the Patient Self-Report of Anxiety Assessment Tool to document the degree of severity of patients' self-reported anxiety | Differences in the severity of anxiety between patients in the treatment and control groups | 12-hour intervals for a year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of PRN antiemetics for prolonged standardized antiemetic regimen | These are patients who self-report blood and marrow transplant conditioning regimen induced nausea and vomiting in the treatment and control cohorts | 1 year | 
| Duration of PRN antiemetics for prolonged standardized antiemetic regimen | These are patients who self-report blood and marrow transplant conditioning regimen induced nausea and vomiting in the treatment and control cohorts | 1 year | 
| Number of PRN anxiolytics for prolonged standardized anxiolytic regimen | These are patients who self-report blood and marrow transplant conditioning regimen induced anxiety in the treatment and control cohorts | 1 year | 
| Duration of PRN anxiolytics for prolonged standardized anxiolytic regimen | These are patients who self-report blood and marrow transplant conditioning regimen induced anxiety in the treatment and control cohorts | 1 year | 
| Using the Patient Self-Report of Anxiety Assessment Tool to document the severity of anxiety prior to and following application of the patch | The level of anxiety in the hour prior to and following application of the patch for patients in the treatment arm | one hour prior to and following application of the patch | 
| Using the Halpin 0-to-5 Nausea and Vomiting Scales to document the severity of nausea/vomiting prior to and following application of the patch | The level of nausea/vomiting in the hour prior to and following application of the patch for patients in the treatment arm | one hour prior to and following application of the patch |