Herbal and Botanical

All Drugs and Chemicals

Peppermint

English Lavender

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.

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.

Lavender Aromatherapy Inhaler Peppermint Aromatherapy Inhaler

Aromatherapy Inhaler

Aubrey Florom-Smith, PhD, RN

Aubrey L Florom-smith, PhD, RN

Aubrey L Florom-Smith, PhD, RN

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).

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.

Aromatherapy Inhaler Use for HSCT Distress

Aromatherapy Inhaler Use for Hematopoietic Stem Cell Transplant Patient Distress

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

Distress "thermometer" (visual analog scale; 0 = No Distress, 10 = Extreme Distress) for rating distress

Distress specific problem list in five domains (checklist); optional open-ended question about "other problems"

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

Log of aromatherapy inhaler use completed by patients.

Chart review using STAnford Research Repository (STARR) of pharmacological Interventions for nausea (ondansetron, lorazepam, prochlorperazine IV or oral, IV aprepitant).

Chart review using STAnford Research Repository (STARR) of pharmacological Interventions for insomnia (trazodone oral, melatonin oral).

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).

5-item Likert-type scale (1 = Terrible, 5 = Neutral, 10 = Exceptional); patient assessment of aromatherapy experience

Stanford University

Neoplasms

All Conditions

Head and Neck Neoplasms

The Usual Care Group will include adult patients undergoing primary surgical treatment for head and neck cancer. Supportive care will be offered or provided according to patients' wishes.

The NAPT Group will include adult patients undergoing primary surgical treatment for head and neck cancer. Patients will be given access to a web-based application that monitors depression, distress, and functional outcomes scores at regular intervals for 12 months. Patients will be able to alert the treatment team of decreased mood, increased distress, and functional issues impacting both. Patients will also be able to track their mood and distress levels throughout the 12 months and involve care-givers in monitoring as well.

Web-based depression and distress monitoring application

NAPT

Brittany Barber

Scott Murray

Brittany Barber, MD

Scott Murray, MD

This is a randomized controlled trial comparing a web-based psychosocial screening application to usual care in a cohort of surgically-treated head and neck cancer patients to determine its efficacy in monitoring depression and distress, and prompting necessary psychiatry/psychology referrals. In addition, treatment adherence, rehabilitation and return to work, primary care utilization, and survival will be monitored.

This is a randomized controlled trial comparing a web-based psychosocial screening application to usual care in a cohort of surgically-treated head and neck cancer patients.

This study will utilize a web-based application available on desktop or laptop computers, and smartphones. The application involves monitoring using the NCCN Distress Thermometer Score, the Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) score, and the Head and Neck Research Network (HNRN-33), a patient-reported, validated functional outcomes score. These assessments will be completed at baseline, 2 weeks postoperatively, and monthly thereafter until 12 months. Patients will have the option of filling out questionnaires more frequently if desired.

This web-based application, the NAPT App, will allow patients to alert the treatment team of their current state of mood or distress. Automatic alerts will be sent to the team if a Distress Score of \</=3, a QIDS score \>/=11, or suicidal ideation are expressed in the application.

The study duration will be 12 months with a primary endpoint of 6 months. Our primary outcome will be NCCN Distress Thermometer Score at 6 months, with secondary outcomes of the QIDS and HNRN-33 functional scores at 6 and 12 months. Additional outcomes assessed will pertain to completion of adjuvant therapy, weight maintenance, rehabilitation and return to work, and survival. Health services delivery outcomes, such as primary care visits, emergency department visits, hospitalizations, and narcotic use will also be evaluated.

Northern Alberta Psychosocial Telecare (NAPT) Screening for HNC Patients

Northern Alberta Psychosocial Telecare (NAPT) Screening for Surgical Head and Neck Cancer Patients: a Randomized Controlled Trial

Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR)

Completion of Adjuvant Therapy, including radiation or chemotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Aromatherapy Inhaler Use for HSCT Distress	NCT05302583	Cancer Distress Cancer Coping Hematopoetic St... Aromatherapy	Aromatherapy In...	19 Years -	Stanford University
Northern Alberta Psychosocial Telecare (NAPT) Screening for HNC Patients	NCT03215199	Cancer Distress	NAPT	18 Years -	University of Alberta

Spots Global Cancer Trial Database for cancer distress