Behaviors and Mental Disorders

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Anxiety Disorders

Breast Neoplasms

Head and Neck Neoplasms

Thoracic Neoplasms

Breast Diseases

Skin Diseases

Patients use VR during chemotherapy infusion on study.

Patients use smartphone during chemotherapy infusion on study.

Questionnaire Administration

Telephone-Based Intervention

Virtual Technology Intervention

Ryan J Li

This clinical trial evaluates the use of virtual reality (VR) goggles during chemotherapy infusion to reduce anxiety-related symptoms in patients with head and neck, thoracic, hematologic, and breast cancers. Virtual reality headsets provide the ability for users to explore a simulated, three-dimensional environment with which users can interact. In virtual reality users can play interactive games, enjoy relaxing experiences, and watch immersive videos. The use of VR goggles may help with anxiety management during chemotherapy infusion.

PRIMARY OBJECTIVE:

I. To evaluate the effectiveness of VR therapy in reducing severity of anxiety symptoms during chemotherapy infusion, compared to participants utilizing a smartphone as a control.

SECONDARY OBJECTIVES:

I. To evaluate whether there is a short-term effect of VR use in anxiety levels.

II. To assess participant satisfaction with their chemotherapy infusion experience in the control and treatment groups.

EXPLORATORY OBJECTIVE:

I. To assess participants' reported adverse effects associated with VR headset use.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP 1: Patients use VR during chemotherapy infusion on study.

GROUP 2: Patients use smartphone during chemotherapy infusion on study.

Use of Virtual Reality Goggles During Chemotherapy Infusion to Reduce Anxiety-Related Symptoms

Anxiety in the Context of Chemotherapy Infusion: Is There an Association Between the Use of Virtual Reality Goggles and Changes in Anxiety-Related Symptoms?

Will be assessed in the treatment and control groups determined by the difference in the scores provided by the State Anxiety Inventory before and right after VR use. Range of scores is 20-80, the higher score indicating greater anxiety. Will be compared using two-sample t-test to compare the anxiety levels change before and after VR between intervention group and control group (VR vs control). The effect of VR on anxiety levels will be described using a linear regression model addressing the unanticipated imbalance between treatment groups after randomization adjusting for the confounder.

Will be assessed by the difference in anxiety levels right before VR use and immediately after chemotherapy infusion is completed as provided by the State Anxiety Inventory using a two sample t-test. Range of scores is 20-80, with a higher score indicating greater anxiety.

Will be assessed by an investigator-designed satisfaction questionnaire after chemotherapy completion to assess participants' satisfaction with the VR device using descriptive statistics to summarize this data.

Oregon Health and Science University

OHSU Knight Cancer Institute

Principal Investigator

Patients and their caregivers participate use the electronic symptom monitoring program to log symptoms QW for 24 weeks. Patients and their caregivers also watch a video and review education materials prior to starting the remote symptom monitoring program.

Educational Activity

Electronic Health Record Review

Participate use the electronic symptom monitoring program to log symptoms

Internet-Based Intervention

Media Intervention

Survey Administration

The Ohio State Comprehensive Cancer Center

Julia L. Agne, MD

Julia L Agne, MD

This clinical trial evaluates earlier symptom management through remote electronic symptom monitoring (such as through an app on patient's phone), and accessibility of palliative care self-referral by patients with thoracic cancer and caregivers by proxy (legal representative). Thoracic cancer occurs in the chest and often causes symptoms for patients. Patients and/or their caregivers are often unable to attend in-person clinic visits for various reasons. The most frequently reported symptom by patients at initial palliative care consultations is pain, and caregivers' most common concerns are pain management for the patient, stress reduction, and fears about patient decline. Earlier palliative care referral can help control these symptoms before they worsen, providing a better quality of life for patients and caregivers. improve physical and emotional functioning for patients and caregivers in cancer care. This study may help researchers learn how an electronic symptom monitoring program may provide an earlier and more accessible way for patients with thoracic cancer to receive palliative care.

PRIMARY OBJECTIVE:

I. Develop and assess feasibility of a remote electronic symptom monitoring program with a prompted option for palliative care self-referral for patients or caregivers by proxy after diagnosis of a thoracic malignancy.

SECONDARY OBJECTIVE:

I. Evaluate palliative care referral patterns after implementation of a remote electronic symptom monitoring program.

OUTLINE:

Patients and their caregivers use the electronic symptom monitoring program to log symptoms once a week (QW) for 24 weeks. Patients and their caregivers also watch a video and review education materials prior to starting the remote symptom monitoring program.

After completion of study intervention, participants are followed up to 2 years.

Electronic Symptom Monitoring Program for Triggered Palliative Referrals in Patients With Thoracic Cancer

SyMPLER: Patient- and Caregiver-Triggered Palliative Referrals Via an Electronic Symptom Monitoring Program

Will estimate that ≥ 50% of patient participants will log symptoms at least monthly through the remote electronic symptom monitoring program.

Descriptive statistics will include study enrollment rates (eligible vs. ineligible participants, consented vs. refused), completion rate of weekly symptom monitoring (patient vs. caregiver by proxy), and person requesting palliative care services (patient vs. caregiver by proxy vs. medical provider), if applicable. Will be considered feasible if within 20% of target enrollment.

Symptom scores (Edmonton Symptom Assessment Scale revised with Constipation and Sleep \[ESAS-r-CS\]) reported by patients and caregivers will be tracked and their association with palliative care referral, if applicable, will be assessed.

Descriptive statistics will be used to assess for congruency between patient and proxy-reported symptom assessments. Patients' oncologic treatment (chemotherapy, immunotherapy, radiation therapy, surgery) will be abstracted from the electronic medical record (EMR) at the time of each ESAS-r-CS survey completed by either the patient or caregiver by proxy.

Palliative care referrals pre- and post- launch of the SyMPLER study will be evaluated for trends. Historical control data collecting palliative referrals by month will be compared between groups (pre-post- launch).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Use of Virtual Reality Goggles During Chemotherapy Infusion to Reduce Anxiety-Related Symptoms	NCT05793957	Hematopoietic a... Malignant Breas... Malignant Head ... Malignant Solid... Malignant Thora...	Questionnaire A... Telephone-Based... Virtual Technol...	18 Years - 89 Years	OHSU Knight Cancer Institute
Use of Virtual Reality Goggles During Chemotherapy Infusion to Reduce Anxiety-Related Symptoms	NCT05793957	Hematopoietic a... Malignant Breas... Malignant Head ... Malignant Solid... Malignant Thora...	Questionnaire A... Telephone-Based... Virtual Technol...	18 Years - 89 Years	OHSU Knight Cancer Institute
Electronic Symptom Monitoring Program for Triggered Palliative Referrals in Patients With Thoracic Cancer	NCT06396598	Malignant Thora...	Educational Act... Electronic Heal... Internet-Based ... Media Intervent... Survey Administ...	18 Years -	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for malignant thoracic neoplasm