Clinical trial NCT04278534: Virtual Reality for the Education of Cancer Patients Undergoing Radiation Therapy
Official title: A Randomized Controlled Trial to Assess the Effectiveness of Virtual Reality in Education for Cancer Patients Undergoing Radiation Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Malignant Neoplasm
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
First posted: 2020-02-20
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knowledge of radiation therapy (RT)
timeFrame: 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:
measure: Anxiety in radiation therapy
timeFrame: 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:
measure: Knowledge in radiation therapy
timeFrame: Prior to start of planned RT on the first treatment day up to the last week of planned RT (up to 9 weeks)
measure: Anxiety in radiation therapy
timeFrame: Prior to start of planned RT on the first treatment day up to the last week of planned RT (up to 9 weeks)
measure: Proportion of information contribution by interprofessional team
timeFrame: Prior to start of planned RT on the first treatment day up to the last week of planned RT (up to 9 weeks)
measure: Frequency/benefits of information sources
timeFrame: Prior to start of planned RT on the first treatment day up to the last week of planned RT (up to 9 weeks)
measure: Overall satisfaction in knowledge gained regarding RT treatment
timeFrame: Prior to start of planned RT on the first treatment day up to the last week of planned RT (up to 9 weeks)
measure: Knowledge and anxiety in radiation therapy
timeFrame: Prior to start of planned RT on the first treatment day up to the last week of planned RT (up to 9 weeks)
Locations:
city: Portland
country: United States
facility: Compass Oncology Rose Quarter
state: Oregon
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Kristi Tonning
role: PRINCIPAL_INVESTIGATOR
References: