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Aromatherapy for HSCT Distress

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05302583
Recruitment Status : Not yet recruiting
First Posted : March 31, 2022
Last Update Posted : January 27, 2023
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Cancer Distress Cancer Coping Hematopoetic Stem Cell Transplant Aromatherapy Other: Aromatherapy Inhaler Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Aromatherapy Inhaler Use for Hematopoietic Stem Cell Transplant Patient Distress
Estimated Study Start Date : February 2023
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024
Arms and Interventions
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Arm Intervention/treatment
SOC only then SOC plus Aromatherapy Inhaler
  1. Participant will receive standard of care pharmacological intervention (SOC) as needed throughout the day.
  2. Participants will complete the Standard of Care Pharmacological Intervention Use Log.
  3. At between 1300 and 1500 hours, study personnel will administer the NCCN Distress Thermometer and Problem List.
 Other: Aromatherapy Inhaler
Lavender Aromatherapy Inhaler Peppermint Aromatherapy Inhaler
SOC and Aromatherapy Inhaler then SOC only
  1. Participant will use the aromatherapy inhaler as needed for up to two (2) hours in the morning and complete the Aromatherapy Inhaler Use Log.
  2. At between 1300 and 1500 hours, study personnel will administer the NCCN Distress Thermometer and Problem List.
 Other: Aromatherapy Inhaler
Lavender Aromatherapy Inhaler Peppermint Aromatherapy Inhaler


Outcome Measures
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Primary Outcome Measures :
  1. Change in Attitudes and Beliefs about Complementary and Alternative Medicine Survey [ Time Frame: Phase 1 Baseline (Transplant Day +1, +2 or +3), Phase 3 (Transplant Day +3, +4 or +5) ]
    15-item Likert-type scale (1 = Strongly Disagree, 5 = Strongly Agree); domain scores range between 0 and 100 and are evaluated separately; higher scores indicate greater expected benefits, perceived barriers, and positive subjective norms

  2. Change in NCCN Distress Thermometer [ Time Frame: Phase 1 Baseline (Transplant Day +1, +2 or +3); through Study Completion Day (Transplant Day +4, +5 or +6) ]
    Distress "thermometer" (visual analog scale; 0 = No Distress, 10 = Extreme Distress) for rating distress

  3. Change in NCCN Distress Problem List [ Time Frame: Phase 1 Baseline (Transplant Day +1, +2 or +3) through Study Completion Day (Transplant Day +4, +5 or +6) ]
    Distress specific problem list in five domains (checklist); optional open-ended question about "other problems"

  4. Change in Cancer Behavior Inventory (Brief Form) [ Time Frame: Phase 1 Baseline (Transplant Day +1, +2 or +3) through Study Completion Day (Transplant Day +4, +5, or +6) ]
    12-item Likert-type scale (1 = Not at all Confident, 5 = Moderately Confident, 10 = Totally Confident); rate level of confidence in range of activities, behaviors and feelings while undergoing and after cancer treatment

  5. Aromatherapy Inhaler Use Log [ Time Frame: Up to 6 days ]
    Log of aromatherapy inhaler use completed by patients.

  6. Standard of Care Pharmacological Interventions - Nausea (STAnford Research Repository - STARR) [ Time Frame: Up to 6 days ]
    Chart review using STAnford Research Repository (STARR) of pharmacological Interventions for nausea (ondansetron, lorazepam, prochlorperazine IV or oral, IV aprepitant).

  7. Standard of Care Pharmacological Interventions - Insomnia [ Time Frame: Phase 1 (Transplant Day +1, +2 or +3), Phase 3 (Transplant Day +3, +4 or +5) ]
    Chart review using STAnford Research Repository (STARR) of pharmacological Interventions for insomnia (trazodone oral, melatonin oral).

  8. Standard of Care Pharmacological Interventions - Pain [ Time Frame: Up to 6 days ]
    Chart review using STAnford Research Repository (STARR) of pharmacological Interventions for pain (oxycodone oral, hydromorphone IV or oral, IV fentanyl, acetaminophen oral, morphine IV or oral).

  9. Final Evaluation of Aromatherapy [ Time Frame: Study Completion Day (Transplant Day +4, +5, or +6) ]
    5-item Likert-type scale (1 = Terrible, 5 = Neutral, 10 = Exceptional); patient assessment of aromatherapy experience


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05302583


Contacts
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Contact: Aubrey Florom-Smith, PhD, RN 650-285-9512 aubsmith@stanford.edu

Locations
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United States, California
Aubrey Florom-smith
Stanford, California, United States, 94305
Contact: Aubrey L Florom-smith, PhD, RN    650-285-9512    afloromsmith@stanfordhealthcare.org   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Aubrey L Florom-Smith, PhD, RN Stanford University
More Information
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT05302583    
Other Study ID Numbers: IRB-65140
First Posted: March 31, 2022    Key Record Dates
Last Update Posted: January 27, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No