Cancer DistressNCT05302583
Aromatherapy Inhaler Use for HSCT Distress
A study testing Aromatherapy Stick in people with Cancer Distress and Cancer Coping, run by Stanford University at 1 site in United States.
Trial 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) . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Distress, Cancer Coping, Hematopoetic Stem Cell Transplant
- What is being tested?
- Aromatherapy Stick
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94305
Anna Oh, PhD, MPH, RN, 650-512-6691, aoh2@stanford.edu
Anna Oh, PhD, MPH, RN
About this study
Official title: Aromatherapy Inhaler Use for Hematopoietic Stem Cell Transplant Patient Distress
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.
Read the 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.
- Being tested
- Aromatherapy Stick, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatherapy StickOther
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.
Standard of CareOther
Participants receive standard inpatient supportive care during the acute post-HCT period. No aromatherapy inhaler is provided.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Participants receive standard supportive care during hospitalization. No aromatherapy stick is provided. Receives: Other: Standard of Care |
| 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. Receives: Other: Aromatherapy Stick |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline: SOC/Inhaler Use Day (Transplant Day +1, +2, or +3); Follow-up: Study Completion Day (Transplant Day +2, +3, or +4)
Secondary outcomes (3)
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.
Measured: Baseline: SOC/Inhaler Use Day (Transplant Day +1, +2, or +3); Follow-up: Study Completion Day (Transplant Day +2, +3, or +4)
Aromatherapy Inhaler Use Log (Inhaler Use Log)
Number of aromatherapy inhalations recorded by participants on a paper log during the Inhaler Use Day.
Measured: 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.)
Measured: Study Completion Day (Transplant Day +4, +5, or +6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start16 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer DistressStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Oh, PhD, MPH, RN, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302583
- Sponsor's protocol ID
- IRB-65140
- Other IDs
- NCI-2026-02783
- Status last verified
- Aug 2026
- First submitted
- 21 Mar 2022
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatherapy Inhaler Use for Hematopoietic Stem Cell Transplant Patient Distress
- ClinicalTrials.gov ID
- NCT05302583
- Acronym / sponsor ID
- IRB-65140
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Standard of CareParticipants receive standard supportive care during hospitalization. No aromatherapy stick is provided. |
| Aromatherapy + Usual Care | Experimental | Other: Aromatherapy StickParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aromatherapy StickParticipants 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. | Other | Aromatherapy + Usual Care |
| Standard of CareParticipants receive standard inpatient supportive care during the acute post-HCT period. No aromatherapy inhaler is provided. | Other | Usual Care |
Primary outcome
Change in cancer distress (NCCN Distress Thermometer)
Time frame: 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.
3 secondary outcomes
Change in cancer coping self-efficacy (Cancer Behavior Inventory-Brief Form, modified)
Time frame: Baseline: SOC/Inhaler Use Day (Transplant Day +1, +2, or +3); Follow-up: Study Completion Day (Transplant Day +2, +3, or +4)
Aromatherapy Inhaler Use Log (Inhaler Use Log)
Time frame: 1 day (Inhaler Use Day)
Aromatherapy experience (Final Evaluation of Aromatherapy)
Time frame: Study Completion Day (Transplant Day +4, +5, or +6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Oh, PhD, MPH, RN principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy Stick in people with Cancer Distress and Cancer Coping, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Oh, PhD, MPH, RN (650-512-6691, aoh2@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cancer distress (NCCN Distress Thermometer) (time frame: Baseline: SOC/Inhaler Use Day (Transplant Day +1, +2, or +3); Follow-up: Study Completion Day (Transplant Day +2, +3, or +4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.