Aromatherapy, Cancer Coping, Cancer Distress, Hematopoetic Stem Cell Transplant
Conditions
Brief summary
This randomized controlled trial will evaluate the feasibility and acceptability of an inhaled aromatherapy stick for patients during the acute inpatient phase after hematopoietic cell transplantation (HCT) . The study will also explore whether aromatherapy use is associated with short-term changes in patient-reported cancer-related distress and coping self-efficacy.
Detailed description
Patients undergoing hematopoietic cell transplantation (HCT) commonly experience high levels of distress and other symptoms during the acute inpatient period. Inhaled aromatherapy is a low-burden, patient-directed supportive care strategy that may be feasible to deliver during hospitalization. This randomized, parallel-group study will evaluate the feasibility and acceptability of an aromatherapy inhaler ("aromatherapy stick") during the early post-transplant inpatient period and will explore short-term changes in patient-reported outcomes.
Interventions
OTHERAromatherapy Stick
Participants receive aromatherapy inhaler education and an aromatherapy stick for self-administered inhalation during the early post-transplant inpatient period. Aromatherapy use occurs on the assigned Inhaler Use Day (targeted for Transplant Day +1, +2, or +3) and is documented using an inhaler use log. Total exposure is limited to a maximum of 2 hours.
OTHERStandard of Care
Participants receive standard inpatient supportive care during the acute post-HCT period. No aromatherapy inhaler is provided.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cancer distress (NCCN Distress Thermometer) | Baseline: SOC/Inhaler Use Day (Transplant Day +1, +2, or +3); Follow-up: Study Completion Day (Transplant Day +2, +3, or +4) | Change in NCCN Distress Thermometer score (0-10 visual analog scale). Calculated as follow-up score minus baseline score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cancer coping self-efficacy (Cancer Behavior Inventory-Brief Form, modified) | Baseline: SOC/Inhaler Use Day (Transplant Day +1, +2, or +3); Follow-up: Study Completion Day (Transplant Day +2, +3, or +4) | Change in Cancer Behavior Inventory (Brief Form; modified) total score (Likert-type confidence ratings). Calculated as follow-up score minus baseline score. |
| Aromatherapy Inhaler Use Log (Inhaler Use Log) | 1 day (Inhaler Use Day) | Number of aromatherapy inhalations recorded by participants on a paper log during the Inhaler Use Day. |
| Aromatherapy experience (Final Evaluation of Aromatherapy) | Study Completion Day (Transplant Day +4, +5, or +6) | Participant-rated aromatherapy experience using a 5-item Likert-type scale (1 = Terrible, 5 = Neutral, 10 = Exceptional). (Group B only.) |
Countries
United States
Contacts
CONTACTAnna Oh, PhD, MPH, RN
PRINCIPAL_INVESTIGATORAnna Oh, PhD, MPH, RN
Stanford University
Outcome results
None listed