Virtual Reality for the Education of Cancer Patients Undergoing Radiation Therapy

A Randomized Controlled Trial to Assess the Effectiveness of Virtual Reality in Education for Cancer Patients Undergoing Radiation Therapy

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.

Study Overview

• Status: Terminated
• Conditions: Malignant Neoplasm
• Intervention / Treatment: Other: Survey Administration; Other: Educational Intervention; Other: Educational Intervention; Other: Educational Intervention

Detailed Description

PRIMARY OBJECTIVE:

I. To assess if proximal knowledge regarding radiation therapy (RT) treatment is improved as result of radiation therapist-led education sessions utilizing VERT.

SECONDARY OBJECTIVE:

I. To assess if proximal anxiety related to first RT is reduced as result of radiation therapist-led education sessions utilizing VERT.

EXPLORATORY OBJECTIVES:

I. To determine whether self-reported knowledge changes throughout course of RT treatment.

II. To evaluate if self-reported knowledge related to RT treatment differs by patient and tumor characteristics (gender, age, diagnosis, type of cancer, etc.).

III. To determine whether the level of patient knowledge and/or anxiety changes throughout radiation RT treatment.

IV. To evaluate if the level of anxiety related to RT treatment differs by patient and tumor characteristics (gender, age, diagnosis, type of cancer, etc.).

V. To characterize the levels informational support provided by interprofessional RT treatment team needs and knowledge gaps of cancer patients undergoing RT treatment.

VI. To determine the sources of information related to RT treatment being accessed by study participants.

VII. To assess self-reported satisfaction in knowledge gained regarding RT treatment.

VIII. To compare the baseline proximal knowledge and anxiety of Oregon Health and Science University (OHSU) patients with Compass Oncology patients.

OUTLINE: Patients are either randomized to Arm I or 1 of 2 groups of Arm II, or assigned to the observational cohort.

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

ARM II: Patients are randomized to 1 of 2 groups.

ARM II CONTROL GROUP I: Patients receive the usual verbal and written education materials at the first treatment appointment, prior to radiation therapy treatment.

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

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

After completion of study, patients are optionally followed up periodically.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97227
      • Compass Oncology Rose Quarter
    • Portland, Oregon, United States, 97239
      • OHSU Knight Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (VERT); 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: Survey Administration; Ancillary studies; Other: Educational Intervention; Complete radiation therapist-led education module using virtual reality; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Educational Intervention; Receive the usual verbal and written education materials; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Educational Intervention; Complete radiation therapist-led face-to-face education module; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational
Active Comparator: Arm II Control Group I (usual education materials); Patients receive the usual verbal and written education materials at the first treatment appointment, prior to radiation therapy treatment.	Other: Survey Administration; Ancillary studies; Other: Educational Intervention; Complete radiation therapist-led education module using virtual reality; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Educational Intervention; Receive the usual verbal and written education materials; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Educational Intervention; Complete radiation therapist-led face-to-face education module; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational
Active Comparator: Arm II Control Group II (face-to-face education module); Patients complete a radiation therapist-led face-to-face education module at the first treatment appointment, prior to radiation therapy treatment.	Other: Survey Administration; Ancillary studies; Other: Educational Intervention; Complete radiation therapist-led education module using virtual reality; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Educational Intervention; Receive the usual verbal and written education materials; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Educational Intervention; Complete radiation therapist-led face-to-face education module; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational
Active Comparator: Observational Cohort (usual education materials); Observational patients receive the usual verbal and written education materials at the first treatment appointment, prior to radiation therapy treatment.	Other: Survey Administration; Ancillary studies; Other: Educational Intervention; Complete radiation therapist-led education module using virtual reality; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Educational Intervention; Receive the usual verbal and written education materials; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Educational Intervention; Complete radiation therapist-led face-to-face education module; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety in radiation therapy	Measured by part 2 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 CG1 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 VERT intervention of planned RT (up to 9 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge in radiation therapy	Measured by part 1 of the Radiation Therapy Patient Education Survey. Paired t-test will be used to determine if total scores for knowledge and anxiety at the end of RT (as measured in Survey 2.0) differs from before the RT starts (Survey 1.1 for subjects in Arm 1 and Arm 2 CG2, and Survey 1.0 for Arm 2 CG 1). Linear regression model will be used to evaluate the association between change in total scores for knowledge/anxiety at the end of RT from before the RT starts and patient/tumor characteristics.	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	Measured by part 2 of the Radiation Therapy Patient Education Survey. Paired t-test will be used to determine if total scores for knowledge and anxiety at the end of RT (as measured in Survey 2.0) differs from before the RT starts (Survey 1.1 for subjects in Arm 1 and Arm 2 CG2, and Survey 1.0 for Arm 2 CG 1). Linear regression model will be used to evaluate the association between change in total scores for knowledge/anxiety at the end of RT from before the RT starts and patient/tumor characteristics.	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	Measured by part 3 of the Radiation Therapy Patient Education Survey. Paired t-test will be used to determine if total scores for knowledge and anxiety at the end of RT (as measured in Survey 2.0) differs from before the RT starts (Survey 1.1 for subjects in Arm 1 and Arm 2 CG2, and Survey 1.0 for Arm 2 CG 1). Linear regression model will be used to evaluate the association between change in total scores for knowledge/anxiety at the end of RT from before the RT starts and patient/tumor characteristics.	Prior to start of planned RT on the first treatment day up to the last week of planned RT (up to 9 weeks)
Frequency/benefits of information sources	Measured by part 4 of the Radiation Therapy Patient Education Survey. Paired t-test will be used to determine if total scores for knowledge and anxiety at the end of RT (as measured in Survey 2.0) differs from before the RT starts (Survey 1.1 for subjects in Arm 1 and Arm 2 CG2, and Survey 1.0 for Arm 2 CG 1). Linear regression model will be used to evaluate the association between change in total scores for knowledge/anxiety at the end of RT from before the RT starts and patient/tumor characteristics.	Prior to start of planned RT on the first treatment day up to the last week of planned RT (up to 9 weeks)
Overall satisfaction in knowledge gained regarding RT treatment	Measured by part 5 of the Radiation Therapy Patient Education Survey. Paired t-test will be used to determine if total scores for knowledge and anxiety at the end of RT (as measured in Survey 2.0) differs from before the RT starts (Survey 1.1 for subjects in Arm 1 and Arm 2 CG2, and Survey 1.0 for Arm 2 CG 1). Linear regression model will be used to evaluate the association between change in total scores for knowledge/anxiety at the end of RT from before the RT starts and patient/tumor characteristics.	Prior to start of planned RT on the first treatment day up to the last week of planned RT (up to 9 weeks)
Knowledge and anxiety in radiation therapy	Measured by part 1 and part 2 of the Radiation Therapy Patient Education Survey. Paired t-test will be used to determine if total scores for knowledge and anxiety at the end of RT (as measured in Survey 2.0) differs from before the RT starts (Survey 1.1 for subjects in Arm 1 and Arm 2 CG2, and Survey 1.0 for Arm 2 CG 1). Linear regression model will be used to evaluate the association between change in total scores for knowledge/anxiety at the end of RT from before the RT starts and patient/tumor characteristics.	Prior to start of planned RT on the first treatment day up to the last week of planned RT (up to 9 weeks)

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University
• Investigators: Principal Investigator: Kristi Tonning, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2020
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: STUDY00020015 (Other Identifier: OHSU Knight Cancer Institute); NCI-2020-00729 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No