NCT05135260

Brief Summary

This study will investigate the ability of virtual reality to function as a novel distraction intervention and improve the experience of patients who are receiving chemotherapy in the infusion clinic.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2023

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

2.1 years

First QC Date

November 9, 2021

Last Update Submit

October 15, 2024

Conditions

CancerChemotherapy

Outcome Measures

Primary Outcomes (3)

  • Positive or negative effect of Virtual Reality therapy on improving the experience of participants receiving chemotherapy

    Measured by the Positive and Negative Affect Scale (0=minimum to 5=maximum). Consisting of a number of words that describe different feelings and emotions. Patients are instructed to indicate to what extent they currently feel each of the feelings or emotions. Afterwards, patient responses are scored to produce a numerical positive affect score and a negative affect score.

    Approximately 12 months

  • Measure the affect of Virtual Reality Therapy on improving stress

    Measured by stress level using the stress numerical rating

    Approximately 12 months

  • Measure the affect of Virtual Reality Therapy on improving pain

    Measured by pain level using the pain numerical score (scale 0 (none) to 10 (worst)

    Approximately 12 months

Secondary Outcomes (1)

  • Rate of cyber sickness (Virtual Reality Therapy Arm Only)

    Approximately 12 months

Study Arms (2)

Virtual Reality Therapy

EXPERIMENTAL

Participants will watch videos for 11 minutes that will allow them to view nature, dinosaurs, animals, and human interactions in three dimension.

Behavioral: Virtual reality therapyBehavioral: QuestionnairesProcedure: Measure heart rateBehavioral: Cyber sickness measurement

Control Group

ACTIVE COMPARATOR

This group will not watch videos, but will continue with their normal routine as if nothing has changed.

Behavioral: QuestionnairesProcedure: Measure heart rate

Interventions

Virtual reality therapyBEHAVIORAL

Participants will watch a video allowing them to view nature, dinosaurs, animals, and human interactions in three dimensions during a session lasting 11 minutes.

Virtual Reality Therapy
QuestionnairesBEHAVIORAL

Questionnaires will be completed regarding stress, pain and affect

Control GroupVirtual Reality Therapy
Measure heart ratePROCEDURE

To be measured prior to starting treatment and halfway through the 11 minute Video

Control GroupVirtual Reality Therapy
Cyber sickness measurementBEHAVIORAL

To be measured using the fast motion sickness scale

Virtual Reality Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At or above the age of 18
  • English Speaking
  • Diagnosed with cancer
  • No previous history of seizures, losses of awareness, or other symptoms linked to an epileptic condition
  • Not sensitive to motion sickness
  • Not currently experiencing any contagious conditions, infections, or diseases (particularly of the eyes, skin, or scalp)
  • Does not use a device to regulate heart rate or rhythm (such as a pacemaker)
  • Not taking antiarrhythmic medications
  • Not actively receiving radiopharmaceutical therapy

You may not qualify if:

  • To ensure that there is sufficient time to complete the virtual reality treatment, patients who are scheduled for visits for periods of less than one hour will not be included in this study. Additionally, patients must consent to participating in the study on the day of the experience.
  • Patients who are asleep prior to consenting will not be asked to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Virtual Reality Exposure TherapySurveys and Questionnaires

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Cody Stansel, MSN

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 9, 2021

First Posted

November 26, 2021

Study Start

November 1, 2021

Primary Completion

December 16, 2023

Study Completion

December 16, 2023

Last Updated

October 16, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)