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

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

Study Overview

• Status: Completed
• Conditions: Nausea; Vomiting; Anxiety
• Intervention / Treatment: Other: Elequil Aromatabs

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Anxiety Arm (Treatment); Patient will receive Elequil Aromatabs	Other: Elequil Aromatabs; There will be a variety of different Aromatabs such as orange/peppermint or lavender
EXPERIMENTAL: Nausea/Vomiting Arm (Treatment); Patient will receive Elequil Aromatabs	Other: Elequil Aromatabs; There will be a variety of different Aromatabs such as orange/peppermint or lavender
NO_INTERVENTION: Nausea/Vomiting Arm (Control); Patient will not receive Elequil Aromatabs
NO_INTERVENTION: Anxiety Arm (Control); Patient will not receive Elequil Aromatabs

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hackensack Meridian Health
• Investigators: Principal Investigator: Megan Tracey, MSN, Hackensack Meridian Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 27, 2017
• Primary Completion (ACTUAL): October 2, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (ACTUAL): August 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Vomiting
• Other Study ID Numbers: PRO2017-0162

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data will be handled in a confidential manner to meet mandated IT security standards and prevent loss of privacy. All electronic files will be stored in an encrypted and password-protected database on a secure medical center server. Any research data extracted from participants' medical records will be recorded in REDCap and electronic spreadsheets will be kept on a password protected computer. The information will be de-identified for study analysis. If the results of the trial are published, participants' identities will remain confidential and all data will be presented in the aggregate.

Publications resulting from this research will not contain any information that could potentially identify participants, either directly or indirectly.

• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No