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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-02783 | Registry Identifier | National Cancer Institute Clinical Trials Reporting Program |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | Participants receive standard supportive care during hospitalization. No aromatherapy stick is provided. |
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| Aromatherapy + Usual Care | Experimental | Participants receive standard supportive care plus aromatherapy inhaler education and an aromatherapy stick for self-administered inhalation. Aromatherapy use occurs on the assigned Inhaler Use Day (targeted for Transplant Day +1, +2, or +3). Use is tracked with an inhaler use log. The aromatherapy "dose" is standardized by a maximum total exposure time (up to 2 hours total), while allowing participants to choose how to distribute use. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aromatherapy Stick | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cancer distress (NCCN Distress Thermometer) | Change in NCCN Distress Thermometer score (0-10 visual analog scale). Calculated as follow-up score minus baseline score. | Baseline: SOC/Inhaler Use Day (Transplant Day +1, +2, or +3); Follow-up: Study Completion Day (Transplant Day +2, +3, or +4) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cancer coping self-efficacy (Cancer Behavior Inventory-Brief Form, modified) | Change in Cancer Behavior Inventory (Brief Form; modified) total score (Likert-type confidence ratings). Calculated as follow-up score minus baseline score. | Baseline: SOC/Inhaler Use Day (Transplant Day +1, +2, or +3); Follow-up: Study Completion Day (Transplant Day +2, +3, or +4) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Oh, PhD, MPH, RN | Contact | 650-512-6691 | aoh2@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anna Oh, PhD, MPH, RN | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Other | Participants receive standard inpatient supportive care during the acute post-HCT period. No aromatherapy inhaler is provided. |
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| Aromatherapy Inhaler Use Log (Inhaler Use Log) | Number of aromatherapy inhalations recorded by participants on a paper log during the Inhaler Use Day. | 1 day (Inhaler Use Day) |
| Aromatherapy experience (Final Evaluation of Aromatherapy) | Participant-rated aromatherapy experience using a 5-item Likert-type scale (1 = Terrible, 5 = Neutral, 10 = Exceptional). (Group B only.) | Study Completion Day (Transplant Day +4, +5, or +6) |