Malignant NeoplasmNCT04278534
Virtual Reality for the Education of Cancer Patients Undergoing Radiation Therapy
A study testing Educational Intervention and Survey Administration in people with Malignant Neoplasm, run by OHSU Knight Cancer Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Educational Intervention and Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 May 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Compass Oncology Rose Quarter
Portland, Oregon, 97227
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess if proximal knowledge regarding radiation therapy (RT) treatment is improved as result of radiation therapist-led education sessions utilizing VERT.
SECONDARY OBJECTIVE:
- To assess if proximal anxiety related to first RT is reduced as result of radiation therapist-led education sessions utilizing VERT.
EXPLORATORY OBJECTIVES:
- 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.).
- 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
- Malignant Neoplasm
- Being tested
- Educational Intervention, Survey Administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Complete radiation therapist-led education module using virtual reality
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive the usual verbal and written education materials
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Complete radiation therapist-led face-to-face education module
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Educational Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start28 May 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Why it stopped: Inadequate enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Kristi Tonning, OHSU Knight Cancer Institute
- Investigators
- Kristi Tonning, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278534
- Sponsor's protocol ID
- STUDY00020015
- Other IDs
- NCI-2020-00729, STUDY00020015
- Status last verified
- Aug 2023
- First submitted
- 18 Feb 2020
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Assess the Effectiveness of Virtual Reality in Education for Cancer Patients Undergoing Radiation Therapy
- ClinicalTrials.gov ID
- NCT04278534
- Acronym / sponsor ID
- STUDY00020015
- Conditions
- Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate enrollment
- Enrolment
- 27 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- 28 May 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess if proximal knowledge regarding radiation therapy (RT) treatment is improved as result of radiation therapist-led education sessions utilizing VERT.
SECONDARY OBJECTIVE:
- To assess if proximal anxiety related to first RT is reduced as result of radiation therapist-led education sessions utilizing VERT.
EXPLORATORY OBJECTIVES:
- 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.).
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I (VERT) | Experimental | Other: Educational Intervention, Other: Survey AdministrationPatients 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 Control Group I (usual education materials) | Active comparator | Other: Educational Intervention, Other: Survey AdministrationPatients receive the usual verbal and written education materials at the first treatment appointment, prior to radiation therapy treatment. |
| Arm II Control Group II (face-to-face education module) | Active comparator | Other: Educational Intervention, Other: Survey AdministrationPatients complete a radiation therapist-led face-to-face education module at the first treatment appointment, prior to radiation therapy treatment. |
| Observational Cohort (usual education materials) | Active comparator | Other: Educational Intervention, Other: Survey AdministrationObservational patients receive the usual verbal and written education materials at the first treatment appointment, prior to radiation therapy treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalComplete radiation therapist-led education module using virtual reality | Other | Arm I (VERT) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive the usual verbal and written education materials | Other | Arm II Control Group I (usual education materials), Observational Cohort (usual education materials) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalComplete radiation therapist-led face-to-face education module | Other | Arm II Control Group II (face-to-face education module) |
| Survey AdministrationAncillary studies | Other | 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) |
Primary outcome
Knowledge of radiation therapy (RT)
Time frame: 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)
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.
1 secondary outcome
Anxiety in radiation therapy
Time frame: 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)
Results and safety
The study was stopped early (reason given: Inadequate enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristi Tonning principal investigator
OHSU Knight Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention and Survey Administration in people with Malignant Neoplasm, run by OHSU Knight Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inadequate enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of radiation therapy (RT) (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.