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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-00729 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00020015 | Other Identifier | OHSU Knight Cancer Institute |
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Inadequate enrollment
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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Complete radiation therapist-led education module using virtual reality |
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| 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) |
| 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. |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristi Tonning | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Compass Oncology Rose Quarter | Portland | Oregon | 97227 | United States | ||
| OHSU Knight Cancer Institute |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Educational Intervention | Other | Receive the usual verbal and written education materials |
|
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| Educational Intervention | Other | Complete radiation therapist-led face-to-face education module |
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| Survey Administration | Other | Ancillary studies |
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| 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) |
| 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) |
| Portland |
| Oregon |
| 97239 |
| United States |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |