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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| NCI-2024-05514 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 23234 | Other Identifier | City of Hope Medical Center |
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Accrual goal met
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial evaluates whether using aromatherapy can reduce pain and anxiety for cancer patients during routine biopsy procedures. Because of the discomfort associated with a bone marrow aspirate and biopsy (BMAB), many patients have significant anxiety in addition to their pain. With the current background of the opioid crisis, researchers have been looking for different ways to treat pain and anxiety in cancer patients without using medications that have a risk for abuse. Recent research suggests that using lavender aromatherapy may be an effective and more affordable treatment for anxiety and pain in patients. Information gathered from this study may help researchers determine whether using aromatherapy may help to manage pain and anxiety during biopsy procedures for cancer patients.
PRIMARY OBJECTIVES:
I. To determine the feasibility of utilizing aromatherapy oils during bone marrow biopsy procedures in clinical practice.
II. To assess satisfaction of patients receiving aromatherapy oils during bone marrow biopsy procedures in clinical practice.
SECONDARY OBJECTIVES:
I. To observe the relationship of aromatherapy oils (as compared to placebo aromatherapy) on anxiety in patients undergoing a bone marrow aspirate and biopsy procedure.
II. To observe the relationship of aromatherapy oils (as compared to placebo aromatherapy) on pain in patients undergoing a bone marrow aspirate and biopsy procedure.
III. To observe the relationship of aromatherapy oils (versus placebo aromatherapy) on other symptoms (i.e., physical, emotional symptoms, etc.).
IV. Additionally assess if there are any differences in practitioner procedure evaluation between the groups.
OUTLINE: Patients are randomized to 1 of 3 groups.
GROUP I: Patients inhale lavender oil aromatherapy (LAO) for 20 minutes prior to standard of care (SOC) BMAB and throughout the procedure.
GROUP II: Patients inhale linalool oil aromatherapy (LA) for 20 minutes prior to SOC BMAB and throughout the procedure.
GROUP III: Patients inhale jojoba oil aromatherapy for 20 minutes prior to SOC BMAB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (LOA) | Experimental | Patients inhale LOA for 20 minutes prior to SOC BMAB and throughout the procedure. |
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| Group II (LA) | Experimental | GROUP II: Patients inhale LA for 20 minutes prior to SOC BMAB and throughout the procedure. |
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| Group III (jojoba) | Placebo Comparator | Patients inhale jojoba oil for 20 minutes prior to SOC BMAB. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aromatherapy and Essential Oils | Procedure | Inhale LA |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients participated in the aromatherapy oils (Feasibility) | Will consider the study feasible if > 70% of patients are able to complete the oil treatment (lavender, linalool or placebo). Will be estimated within 95% confidence interval. | Up to 1 month |
| Proportion of patients completed the aromatherapy oils (Feasibility) | Completion will be defined as receiving oil treatments as described. Each patient will be assigned one of the following categories: 1) complete treatment course, 2) incomplete treatment course, or 3) unknown (not assessable, insufficient data). Will be estimated within 95% confidence interval. | Up to 1 month |
| Patient satisfaction | Will be evaluated using a survey, in order to fully understand their experience with the treatment. Will also evaluate whether the patients are interested in aromatherapy oils for future bone marrow aspiration and biopsy (BMAB), and their experience in the clinical trial. Descriptive analyses (exploratory) will be provided for all individual assessment items. | One time patient satisfaction assessment within 30 minutes after bone marrow aspiration and biopsy (BMAB). |
| Measure | Description | Time Frame |
|---|---|---|
| Association between aromatherapy and other symptoms | Will be compared (to placebo aromatherapy) using the ESAS scores for the remaining symptoms via the mixed effect modeling approach. For individual scores, research indicates a change of 1.0-1.5 correlates with a minimal clinically important difference. | The 3 time points are: at baseline before oil administration; after oil administration before BMAB; after BMAB up to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
Allergy to lavender oil, linalool oil, jojoba oil
Previous enrollment in this study
Uncontrolled respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD)
Mental incapacitation (ex. stroke, brain metastasis etc.) that would cause inability to follow directions, in the opinion of the investigators
Ongoing uncontrolled active psychiatric condition that would interfere in the conduct of the study (e.g., mood disorders, anxiety, psychosis disorders, or substance use), as determined by the patient's primary cancer team.
Recent changes in the past 2 weeks to medications prescribed for pain or anxiety
Abnormal smelling abilities due to sinus infections, long COVID, etc.
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| Name | Affiliation | Role |
|---|---|---|
| Richard T Lee | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States | ||
| City of Hope at Lennar |
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| Electronic Health Record Review | Other | Ancillary studies |
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| Jojoba Oil | Other | Inhale jojoba oil aromatherapy |
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| Lavender Oil | Other | Inhale LAO |
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| Questionnaire Administration | Other | Ancillary studies |
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| Association between aromatherapy and anxiety | We will compare differences in anxiety scores between each intervention aromatherapy group (Lavender, Linalool) and Placebo (Jojoba) using independent sample t-test (or Mann-Whitney test). We will assess anxiety scores from the ESAS form, within and between groups, at three specific assessment points (pre-BMAB, post-relaxation, and post-BMAB) via mixed effect regression models (which will account for the correlation between observations on the same patient). We will test for time, and group by time interaction effects. | The 3 time points are: at baseline before oil administration; after oil administration before BMAB; after BMAB up to 24 hours |
| Clinician's responses | Will be assessed using the post-procedure questionnaire. Descriptive analyses will be produced (by group). Furthermore, independent samples t-tests will be applied to determine if there are any differences in practitioner procedure evaluation questions between the two groups. | At post-BMAB up to 24 hours |
| Association between aromatherapy and pain | Will be compared (to placebo aromatherapy) using scores from the pain question of the ESAS. Will also use the Brief Pain Inventory Short Form total score. A statistical analysis similar to the comparison in anxiety scores will be performed. | The 3 time points are: at baseline before oil administration; after oil administration before BMAB; after BMAB up to 24 hours |
| Irvine |
| California |
| 92618 |
| United States |
| ID | Term |
|---|---|
| D019341 | Aromatherapy |
| C034743 | jojoba wax |
| C045718 | lavender oil |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D008517 | Phytotherapy |
| D026421 | Sensory Art Therapies |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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