Aromatherapy Inhaler Use for HSCT Distress

Aromatherapy Inhaler Use for Hematopoietic Stem Cell Transplant Patient Distress

This randomized controlled trial will evaluate the feasibility and acceptability of an inhaled aromatherapy stick for patients during the acute inpatient phase after hematopoietic cell transplantation (HCT) . The study will also explore whether aromatherapy use is associated with short-term changes in patient-reported cancer-related distress and coping self-efficacy.

Study Overview

• Status: Recruiting
• Conditions: Aromatherapy; Cancer Distress; Cancer Coping; Hematopoetic Stem Cell Transplant
• Intervention / Treatment: Other: Standard of Care; Other: Aromatherapy Stick

Detailed Description

Patients undergoing hematopoietic cell transplantation (HCT) commonly experience high levels of distress and other symptoms during the acute inpatient period. Inhaled aromatherapy is a low-burden, patient-directed supportive care strategy that may be feasible to deliver during hospitalization. This randomized, parallel-group study will evaluate the feasibility and acceptability of an aromatherapy inhaler ("aromatherapy stick") during the early post-transplant inpatient period and will explore short-term changes in patient-reported outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Oh, PhD, MPH, RN; Phone Number: 650-512-6691; Email: aoh2@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Principal Investigator: Anna Oh, PhD, MPH, RN
      • Contact: Anna Oh, PhD, MPH, RN; Phone Number: 650-512-6691; Email: aoh2@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Autologous and Allogeneic patients admitted to E1 for planned HSCT
• Patients with hematologic malignancies requiring HSCT
• No allergies to lavender or peppermint essential oils
• Must have received chemotherapy during preparative regimen (single or multi-agent regimen)
• Adult patient over 18 years of age
• Able to speak, read, and comprehend English
• Willing and capable of providing informed consent

Exclusion Criteria:

• Patients admitted for Chimeric Antigen Receptor T cell (CART) infusion
• Patients receiving a transplant for a germ cell tumor diagnosis
• Unexpected/unplanned admission (e.g., neutropenic fever, confusion, clinical deterioration)
• Immune effector cell-associated neurotoxicity syndrome (ICANS) grade 1 through 4
• History of scleroderma
• History of atrial fibrillation
• Known history of G6PD deficiency
• Allergic to lavender or peppermint essential oils
• Pediatric patient 18 years of age or less
• Unable to speak, read, and comprehend English
• Unwilling or incapable of providing informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; Participants receive standard supportive care during hospitalization. No aromatherapy stick is provided.	Other: Standard of Care; Participants receive standard inpatient supportive care during the acute post-HCT period. No aromatherapy inhaler is provided.
Experimental: Aromatherapy + Usual Care; Participants receive standard supportive care plus aromatherapy inhaler education and an aromatherapy stick for self-administered inhalation. Aromatherapy use occurs on the assigned Inhaler Use Day (targeted for Transplant Day +1, +2, or +3). Use is tracked with an inhaler use log. The aromatherapy "dose" is standardized by a maximum total exposure time (up to 2 hours total), while allowing participants to choose how to distribute use.	Other: Aromatherapy Stick; Participants receive aromatherapy inhaler education and an aromatherapy stick for self-administered inhalation during the early post-transplant inpatient period. Aromatherapy use occurs on the assigned Inhaler Use Day (targeted for Transplant Day +1, +2, or +3) and is documented using an inhaler use log. Total exposure is limited to a maximum of 2 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cancer distress (NCCN Distress Thermometer)	Change in NCCN Distress Thermometer score (0-10 visual analog scale). Calculated as follow-up score minus baseline score.	Baseline: SOC/Inhaler Use Day (Transplant Day +1, +2, or +3); Follow-up: Study Completion Day (Transplant Day +2, +3, or +4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cancer coping self-efficacy (Cancer Behavior Inventory-Brief Form, modified)	Change in Cancer Behavior Inventory (Brief Form; modified) total score (Likert-type confidence ratings). Calculated as follow-up score minus baseline score.	Baseline: SOC/Inhaler Use Day (Transplant Day +1, +2, or +3); Follow-up: Study Completion Day (Transplant Day +2, +3, or +4)
Aromatherapy Inhaler Use Log (Inhaler Use Log)	Number of aromatherapy inhalations recorded by participants on a paper log during the Inhaler Use Day.	1 day (Inhaler Use Day)
Aromatherapy experience (Final Evaluation of Aromatherapy)	Participant-rated aromatherapy experience using a 5-item Likert-type scale (1 = Terrible, 5 = Neutral, 10 = Exceptional). (Group B only.)	Study Completion Day (Transplant Day +4, +5, or +6)

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Anna Oh, PhD, MPH, RN, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: IRB-65140; NCI-2026-02783 (Registry Identifier: National Cancer Institute Clinical Trials Reporting Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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