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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
50
Lavender Aromatherapy Inhaler Peppermint Aromatherapy Inhaler
Stanford University
Stanford, California, United States
RECRUITINGChange 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
Time frame: 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
Time frame: 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"
Time frame: 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
Time frame: 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.
Time frame: 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).
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Time frame: 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).
Time frame: 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).
Time frame: Up to 6 days
Final Evaluation of Aromatherapy
5-item Likert-type scale (1 = Terrible, 5 = Neutral, 10 = Exceptional); patient assessment of aromatherapy experience
Time frame: Study Completion Day (Transplant Day +4, +5, or +6)