Virtual Reality for the Education of Cancer Patients Undergoing Radiation Therapy

NCT ID: NCT04278534

Last Updated: 2023-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-28

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malignant Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Complete radiation therapist-led education module using virtual reality

Survey Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type ACTIVE_COMPARATOR

Educational Intervention

Intervention Type OTHER

Receive the usual verbal and written education materials

Survey Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type ACTIVE_COMPARATOR

Educational Intervention

Intervention Type OTHER

Complete radiation therapist-led face-to-face education module

Survey Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type ACTIVE_COMPARATOR

Educational Intervention

Intervention Type OTHER

Receive the usual verbal and written education materials

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Educational Intervention

Complete radiation therapist-led education module using virtual reality

Intervention Type OTHER

Educational Intervention

Receive the usual verbal and written education materials

Intervention Type OTHER

Educational Intervention

Complete radiation therapist-led face-to-face education module

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Education for Intervention Intervention by Education Intervention through Education Intervention, Educational

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Kristi Tonning

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristi Tonning

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

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Compass Oncology Rose Quarter

Portland, Oregon, United States

Site Status

OHSU Knight Cancer Institute

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2020-00729

Identifier Type: REGISTRY

Identifier Source: secondary_id

STUDY00020015

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00020015

Identifier Type: -

Identifier Source: org_study_id

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