Aromatherapy Inhaler Use for HSCT Distress

Aromatherapy Clinical Trial

Official title:

Aromatherapy Inhaler Use for Hematopoietic Stem Cell Transplant Patient Distress

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05302583
• Other study ID #: IRB-65140
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: Stanford University
• Contact: Aubrey Florom-Smith, PhD, RN
• Phone: 650-285-9512
• Email: aubsmith[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Phase 1: Transplant Day +1, +2, or +3. Phase 2: Washout Day: Standard of care (SOC) pharmacological intervention only. Phase 3: Transplant Day +3, +4, or +5). Study Completion: Transplant Day +4, +5, or +6. *Study activities will occur on a single day for each phase. However, a three-day window for Phases 1 and 3 will allow consideration of patients' ability to participate in the immediate post-transplant period.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aromatherapy
• Cancer Distress
• Hematopoetic Stem Cell Transplant

Intervention

Other:
• Aromatherapy Inhaler
Lavender Aromatherapy Inhaler Peppermint Aromatherapy Inhaler

Locations

Country	Name	City	State
United States	Aubrey Florom-smith	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Aromatherapy Inhaler Use Log	Log of aromatherapy inhaler use completed by patients.	Up to 6 days
Primary	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
Primary	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)
Primary	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
Primary	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)