Clinical trial NCT05302583: Aromatherapy Inhaler Use for HSCT Distress
Official title: Aromatherapy Inhaler Use for Hematopoietic Stem Cell Transplant Patient Distress
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer Distress
Cancer Coping
Hematopoetic Stem Cell Transplant
Aromatherapy
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Attitudes and Beliefs about Complementary and Alternative Medicine Survey
timeFrame: Phase 1 Baseline (Transplant Day +1, +2 or +3), Phase 3 (Transplant Day +3, +4 or +5)
measure: Change in NCCN Distress Thermometer
timeFrame: Phase 1 Baseline (Transplant Day +1, +2 or +3); through Study Completion Day (Transplant Day +4, +5 or +6)
measure: Change in NCCN Distress Problem List
timeFrame: Phase 1 Baseline (Transplant Day +1, +2 or +3) through Study Completion Day (Transplant Day +4, +5 or +6)
measure: Change in Cancer Behavior Inventory (Brief Form)
timeFrame: Phase 1 Baseline (Transplant Day +1, +2 or +3) through Study Completion Day (Transplant Day +4, +5, or +6)
measure: Aromatherapy Inhaler Use Log
timeFrame: Up to 6 days
measure: Standard of Care Pharmacological Interventions - Nausea (STAnford Research Repository - STARR)
timeFrame: Up to 6 days
measure: Standard of Care Pharmacological Interventions - Insomnia
timeFrame: Phase 1 (Transplant Day +1, +2 or +3), Phase 3 (Transplant Day +3, +4 or +5)
measure: Standard of Care Pharmacological Interventions - Pain
timeFrame: Up to 6 days
measure: Final Evaluation of Aromatherapy
timeFrame: Study Completion Day (Transplant Day +4, +5, or +6)
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Anna Oh, PhD, MPH, RN
role: PRINCIPAL_INVESTIGATOR
References: