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Aromatherapy Inhaler Use for HSCT Distress

ConditionsCancer DistressCancer CopingHematopoetic Stem Cell TransplantAromatherapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aromatherapy Stick

    Other intervention

    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 Care

    Other intervention

    Participants receive standard inpatient supportive care during the acute post-HCT period. No aromatherapy inhaler is provided.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Usual CareActive comparator 1 intervention
Group B: Aromatherapy + Usual CareExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline: SOC/Inhaler Use Day (Transplant Day +1, +2, or +3); Follow-up: Study Completion Day (Transplant Day +2, +3, or +4)

Secondary outcomes

1

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.

Time frame
Baseline: SOC/Inhaler Use Day (Transplant Day +1, +2, or +3); Follow-up: Study Completion Day (Transplant Day +2, +3, or +4)
2

Aromatherapy Inhaler Use Log (Inhaler Use Log)

Number of aromatherapy inhalations recorded by participants on a paper log during the Inhaler Use Day.

Time frame
1 day (Inhaler Use Day)
3

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.)

Time frame
Study Completion Day (Transplant Day +4, +5, or +6)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Source ClinicalTrials.gov
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