Virtual Reality for the Education of Cancer Patients Undergoing Radiation Therapy

NCT04278534 | Terminated

• 2 other identifiers: STUDY00020015NCI-2020-00729
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

This trial studies the use of virtual reality as an educational tool for cancer patients undergoing radiation therapy. The purpose of the study is to learn about virtual reality education (VERT) and if it may be able to help people who are planning to receive radiation therapy. Patient education using virtual reality may result in better understanding and/or decreased anxiety in patients receiving radiation therapy.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• Knowledge of radiation therapy (RT)

  Measured by part 1 of the Radiation Therapy Patient Education Survey by start of RT. The sum of scores from Survey 1.1 for Arm 1 will be compared with that of Arm 2 (using total scores from Survey 1.0 for Arm 2 control group \[CG\]1 and total scores from Survey 1.1 for Arm 2 CG2) using two-sided two-sample t test. Linear regression models will be fitted for adjusted comparison after controlled for disease sites and other important patient and tumor characteristics.

  Prior to start of planned RT, on the first treatment day up to completion of the virtual reality education (VERT) intervention of planned RT (up to 9 weeks)

Secondary Outcomes (1)

• Anxiety in radiation therapy

  Prior to start of planned RT, on the first treatment day up to completion of the VERT intervention of planned RT (up to 9 weeks)

Other Outcomes (6)

• Knowledge in radiation therapy

  Prior to start of planned RT on the first treatment day up to the last week of planned RT (up to 9 weeks)

• Anxiety in radiation therapy

  Prior to start of planned RT on the first treatment day up to the last week of planned RT (up to 9 weeks)

• Proportion of information contribution by interprofessional team

  Prior to start of planned RT on the first treatment day up to the last week of planned RT (up to 9 weeks)

Study Arms (4)

Arm I (VERT)

EXPERIMENTAL

Patients complete a radiation therapist-led education module using virtual reality over 30 minutes at the first treatment appointment, prior to radiation therapy treatment.

Other: Educational Intervention; Other: Survey Administration

Arm II Control Group I (usual education materials)

ACTIVE COMPARATOR

Patients receive the usual verbal and written education materials at the first treatment appointment, prior to radiation therapy treatment.

Other: Educational Intervention; Other: Survey Administration

Arm II Control Group II (face-to-face education module)

ACTIVE COMPARATOR

Patients complete a radiation therapist-led face-to-face education module at the first treatment appointment, prior to radiation therapy treatment.

Other: Educational Intervention; Other: Survey Administration

Observational Cohort (usual education materials)

ACTIVE COMPARATOR

Observational patients receive the usual verbal and written education materials at the first treatment appointment, prior to radiation therapy treatment.

Other: Educational Intervention; Other: Survey Administration

Interventions

Educational Intervention OTHER

Complete radiation therapist-led education module using virtual reality

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm I (VERT)

Survey Administration OTHER

Ancillary studies

Arm I (VERT); Arm II Control Group I (usual education materials); Arm II Control Group II (face-to-face education module); Observational Cohort (usual education materials)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and the willingness to sign a written informed consent document
• All races and ethnic groups will be included
• Participants with any cancer diagnosis that is intended to receive RT for curative intent for their cancer
• Participants must have a minimum of 10 planned RT treatments

You may not qualify if:

• Any prior RT
• Known history of anxiety or depression
• Individuals with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
• Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of participant safety or study results
• Inability to understand either English or Spanish

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator

Study Sites (2)

Compass Oncology Rose Quarter

Portland, Oregon, 97227, United States

Location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Kristi Tonning

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 20, 2020
• Study Start: May 28, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

US (2)