Aromatherapy Inhaler Use for Hematopoietic Stem Cell Transplant Patient Distress
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in NCCN Distress Thermometer
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Usual Care
Participants receive standard supportive care during hospitalization. No aromatherapy stick is provided.
干预措施: Standard of Care (Other)
Aromatherapy + Usual Care
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.
干预措施: Aromatherapy Stick (Other)
结局指标
主要结局
Change in NCCN Distress Thermometer
时间窗: 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
Change in NCCN Distress Problem List
时间窗: 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"
Change in Cancer Behavior Inventory (Brief Form)
时间窗: 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
Change in Attitudes and Beliefs about Complementary and Alternative Medicine Survey
时间窗: 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
Aromatherapy Inhaler Use Log
时间窗: Up to 6 days
Log of aromatherapy inhaler use completed by patients.
Standard of Care Pharmacological Interventions - Insomnia
时间窗: 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).
Standard of Care Pharmacological Interventions - Nausea (STAnford Research Repository - STARR)
时间窗: Up to 6 days
Chart review using STAnford Research Repository (STARR) of pharmacological Interventions for nausea (ondansetron, lorazepam, prochlorperazine IV or oral, IV aprepitant).
Final Evaluation of Aromatherapy
时间窗: 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
Standard of Care Pharmacological Interventions - Pain
时间窗: 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).
次要结局
未报告次要终点