Aromatherapy for HSCT Distress

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Aromatherapy Inhaler Use for Hematopoietic Stem Cell Transplant Patient Distress

Conditions
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Cancer Distress, Cancer Coping, Hematopoetic Stem Cell Transplant, Aromatherapy

Intervention / Treatment
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* Other: Aromatherapy Inhaler


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SOC only then SOC plus Aromatherapy Inhaler<br>Participant will receive standard of care pharmacological intervention (SOC) as needed throughout the day. Participants will complete the Standard of Care Pharmacological Intervention Use Log. At between 1300 and 1500 hours, study personnel will administer the NCCN Distress Thermometer and Problem List. | Other: Aromatherapy Inhaler<br>* Lavender Aromatherapy Inhaler Peppermint Aromatherapy Inhaler<br>|
| Other: SOC and Aromatherapy Inhaler then SOC only<br>Participant will use the aromatherapy inhaler as needed for up to two (2) hours in the morning and complete the Aromatherapy Inhaler Use Log. At between 1300 and 1500 hours, study personnel will administer the NCCN Distress Thermometer and Problem List. | Other: Aromatherapy Inhaler<br>* Lavender Aromatherapy Inhaler Peppermint Aromatherapy Inhaler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |