Aromatherapy Inhaler Use for HSCT Distress

NCT05302583 | Recruiting

• 2 other identifiers: IRB-65140NCI-2026-02783
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to evaluate aromatherapy inhaler use and how it may impact cancer distress and coping by patients in the first few days after hematopoietic stem cell transplant (HSCT).

Conditions

Cancer Distress; Cancer Coping; Hematopoetic Stem Cell Transplant; Aromatherapy

Outcome Measures

Primary Outcomes (9)

• Change in Attitudes and Beliefs about Complementary and Alternative Medicine Survey

  15-item Likert-type scale (1 = Strongly Disagree, 5 = Strongly Agree); domain scores range between 0 and 100 and are evaluated separately; higher scores indicate greater expected benefits, perceived barriers, and positive subjective norms

  Phase 1 Baseline (Transplant Day +1, +2 or +3), Phase 3 (Transplant Day +3, +4 or +5)

• Change in NCCN Distress Thermometer

  Distress "thermometer" (visual analog scale; 0 = No Distress, 10 = Extreme Distress) for rating distress

  Phase 1 Baseline (Transplant Day +1, +2 or +3); through Study Completion Day (Transplant Day +4, +5 or +6)

• Change in NCCN Distress Problem List

  Distress specific problem list in five domains (checklist); optional open-ended question about "other problems"

  Phase 1 Baseline (Transplant Day +1, +2 or +3) through Study Completion Day (Transplant Day +4, +5 or +6)

• Change in Cancer Behavior Inventory (Brief Form)

  12-item Likert-type scale (1 = Not at all Confident, 5 = Moderately Confident, 10 = Totally Confident); rate level of confidence in range of activities, behaviors and feelings while undergoing and after cancer treatment

  Phase 1 Baseline (Transplant Day +1, +2 or +3) through Study Completion Day (Transplant Day +4, +5, or +6)

• Aromatherapy Inhaler Use Log

  Log of aromatherapy inhaler use completed by patients.

  Up to 6 days

• Standard of Care Pharmacological Interventions - Nausea (STAnford Research Repository - STARR)

  Chart review using STAnford Research Repository (STARR) of pharmacological Interventions for nausea (ondansetron, lorazepam, prochlorperazine IV or oral, IV aprepitant).

  Up to 6 days

• Standard of Care Pharmacological Interventions - Insomnia

  Chart review using STAnford Research Repository (STARR) of pharmacological Interventions for insomnia (trazodone oral, melatonin oral).

  Phase 1 (Transplant Day +1, +2 or +3), Phase 3 (Transplant Day +3, +4 or +5)

• Standard of Care Pharmacological Interventions - Pain

  Chart review using STAnford Research Repository (STARR) of pharmacological Interventions for pain (oxycodone oral, hydromorphone IV or oral, IV fentanyl, acetaminophen oral, morphine IV or oral).

  Up to 6 days

• Final Evaluation of Aromatherapy

  5-item Likert-type scale (1 = Terrible, 5 = Neutral, 10 = Exceptional); patient assessment of aromatherapy experience

  Study Completion Day (Transplant Day +4, +5, or +6)

Study Arms (2)

SOC only then SOC plus Aromatherapy Inhaler

OTHER

1. Participant will receive standard of care pharmacological intervention (SOC) as needed throughout the day. 2. Participants will complete the Standard of Care Pharmacological Intervention Use Log. 3. At between 1300 and 1500 hours, study personnel will administer the NCCN Distress Thermometer and Problem List.

Other: Aromatherapy Inhaler

SOC and Aromatherapy Inhaler then SOC only

OTHER

1. Participant will use the aromatherapy inhaler as needed for up to two (2) hours in the morning and complete the Aromatherapy Inhaler Use Log. 2. At between 1300 and 1500 hours, study personnel will administer the NCCN Distress Thermometer and Problem List.

Other: Aromatherapy Inhaler

Interventions

Aromatherapy Inhaler OTHER

Lavender Aromatherapy Inhaler Peppermint Aromatherapy Inhaler

SOC and Aromatherapy Inhaler then SOC only; SOC only then SOC plus Aromatherapy Inhaler

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

Study Officials

• Anna Oh, PhD, MPH, RN

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aubrey Florom-Smith, PhD, RN

CONTACT

650-285-9512; aubsmith@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: June 16, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)